EP1499303A2

EP1499303A2 - Multi-phase, multi-compartment capsular system

Info

Publication number: EP1499303A2
Application number: EP03717010A
Authority: EP
Inventors: Fred H. Miller
Original assignee: Individual
Current assignee: Individual
Priority date: 2002-04-10
Filing date: 2003-04-09
Publication date: 2005-01-26
Also published as: AU2003220689A1; EP1499303A4; AU2009202495B2; WO2003086267B1; WO2003086267A2; WO2003086267A3; JP2005528383A; NZ536267A; CA2481486C; JP2011068664A; AU2009202495A1; AU2011202164A1; CA2481486A1

Abstract

A multi-compartment capsule, comprising, a first receiving chamber comprising at least one ingredient having a first physical state, wherein said ingredient is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral; and a second receiving chamber comprising at least one ingredient having a second physical state, wherein said ingredient is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral; wherein said first physical state of said ingredient of said first receiving chamber being different from said second physical state of said ingredient of said second receiving chamber; and said ingredient of said first receiving chamber being different from said ingredient of said second receiving chamber.

Description

MULTI-PHASE, MULTI-COMPARTMENT CAPSULAR SYSTEM

BACKGROUND

1. Related Applications

This application claims the benefit of U.S. Provisional Application Serial No.

60/371,448, filed April 10, 2002, and entitled "INTEGRATED CAPSULE DELIVERY

APPARATUS AND METHOD," which is hereby incorporated herein by reference. This application further claims the benefit of U.S. Application Serial No. 10/369,427, filed February 18, 2003, entitled "MULTI-PHASE, MULTI-COMPARTMENT CAPSULAR DELIVERY APPARATUS AND METHODS FOR USING SAME," which is hereby incorporated herein by reference. This application further claims the benefit of U.S. Application Serial No. 10/368,951, filed February 18, 2003, entitled "PROCESS FOR ENCAPSULATING MULTI-PHASE, MULTI-COMPARTMENT CAPSULES," which is hereby incorporated herein by reference. This application further claims the benefit of U.S. Application Serial No. 10/369,244, filed on February 18, 2003, and entitled "MULTI-PHASE, MULTI-COMPARTMENT CAPSULAR DELIVERY APPARATUS FOR THERAPEUTIC COMPOSITIONS AND METHODS FOR USING SAME," which is hereby incorpoated herein by reference. This application further claims the benefit of U.S. Application Serial No. 10/369,247, filed February 18, 2003, and entitled "PROCESS FOR ENCAPSULATING MULTI-PHASE, MULTI-COMPARTMENT CAPSULES FOR THERAPEUTIC COMPOSITIONS," which is hereby incorporated herein by reference.

2. The Field ofthe Invention The present invention relates to delivery of active ingredients or medicaments and, more particularly, to novel capsular delivery apparatus and methods for delivering one or more active ingredients or medicaments having diverse physical states (e.g., solid, liquid, gas or dispersion) into a single dosage, multi-compartment capsule.

The present invention further relates to methods for the administration of a plurality of heterogenous chemical and biological compounds to animals and humans using a multicompartment delivery system for treatment of different conditions or the same condition or diseases (different or same) in one or more organ systems.

3. Background ofthe Invention

As appreciated by those skilled in the art, the contemplation, design, testing and manufacture of chemicals and biomolecules for administration to humans and animals, as nutritional or therapeutic agents, requires a thorough integration of clinically contemplated delivery principles and modalities. Chemicals and biomolecules that may be administered to humans and animals are often referred to herein as "actives," "active ingredients" or "medicaments."

Oral administration has become one of the most frequent routes for delivering one or more active ingredients or medicaments to the body. Active ingredients or medicaments, such as nutritional or therapeutic agents, may be orally administered in a variety of physical states (i.e., solid, liquid or gas). Tablets and capsules are generally the most common vehicle for the oral delivery of medicaments. As appreciated, a tablet may be broadly characterized as a compressed powder or granular solid. Prior to compression of the granular powder comprising the medicament into tablet form, the presence of one or more excipients may be required. An excipient includes any inert substance (i.e., gum arabic, starch or the like) combined with a principal ingredient to facilitate the preparation of an agreeable or convenient dosage form ofthe active or medicament. Functional characteristics of excipients may include, for example, disintegration, lubrication, appearance, palatability, shelf-stability or the like.

Those skilled in the art also developed capsules as a contrivance for containing a solid or liquid dosage form of a medicament. Traditional capsular embodiments include a first containment section referred to as a base, and a second containment section referred to as a cap. The two pieces ofthe capsule are usually formulated and designed in a manner such that the material to be encapsulated may be introduced into the base section, whereas the open end of the cap section may be correspondingly positioned over the open end of the base. The walls of the cap and base are generally in physical contact with one another to form a single internal cavity. A means for structurally sealing the cap in relation to the base may also be incorporated during manufacture to insure non-tampering ofthe capsule. In this regard, those skilled in the art developed sealing technology which contemplates banding, heat fusion (spot-welding) and snap seals which utilize a "tongue and groove" scheme.

The outer walls of a capsule are preferably formed of a soluble ingredient, such as, for example, gelatin (animal-based product), starch, hydrophillic polymer or hydroxypropyl methyl-cellulose (HPMC), which provides a barrier for containing the active ingredient or medicament, in powder or liquid form, within the internal periphery of the capsule walls. Traditionally, hard gelatin capsules may be manufactured by dipping plates of stainless steel pins into a pool of gelatin solution. The pins are then removed from the gelatin and rotated while the gelatin is dried in a kiln with forced, humidity-controlled air. Once dried, the gelatin capsules are typically stripped from the pins, trimmed to a suitable length and then joined together (e.g. , base and cap) and packaged for production use.

With the advent of automated encapsulation machinery, the responsibility to produce encapsulated products shifted mainly to industrial manufacturers. Contemporaneous with the development ofthe encapsulation industry, those skilled in the art have advanced the state of the encapsulation art. For example, several significant improvements in encapsulation technology have been seen over the last forty years. These technological improvements have included, for example, the development of soft elastic capsules, film-coating techniques, micro-encapsulation and multiple-compartment technology.

Soft elastic capsules, often referred to as soft gelatin capsules, were developed in an effort to provide means for encapsulating liquids and other medicaments which are typically poorly soluble in water. In preferred design, soft elastic capsules are made from a thicker and more plastic gelatin having an increased flexibility due to the addition of a polyol, such as glycerin or sorbitol. The addition of such plasticizers has been found, however, to have the potential disadvantage of increasing the risk for microbial growth. Thus an antimicrobial, such as a paraben or sorbic acid, may be added to the soft elastic capsule shell in order to address any microbial concern.

Prior art film-coating techniques generally involve a plating process, whereby a thin, uniform film may be deposited onto the outer surface of the delivery vehicle (e.g., tablet or capsule). Several successive layers may be deposited onto the outer surface ofthe vehicle, if desired, in an effort to facilitate various desirable properties. For example, sugar-coating, a , precursor to film-coating, has been used by those skilled in the art for more than one hundred years to make tablets more palatable. Other advantages or properties of film-coating may include for example, but not by way of limitation, protection from moisture, oxidation, controlling microbial contamination and inhibiting modification ofthe chemical properties of the active ingredient. As further appreciated by those skilled in the art, prior art film-coating may form an interfacial barrier between two chemicals or chemical compounds that might otherwise react when they come into contact.

Enteric coatings and sustained-release formulations are contemplated as variations on prior art film-coating techniques. In particular, enteric coating describes a process where the delivery vehicle (e.g., tablet or capsule) is coated with one or more layers of chemicals that are somewhat resistant to extreme pH conditions. For example, conditions of extremely low pH are commonly encounter in the stomach. Many active ingredients or medicaments are in the form of a pharmaeceutical salt and thus highly susceptible to ionization in the presence of hydrogen ions. Thus, the presence of an enteric coating generally provides a level of protection as to degradation of the active ingredient or medicament until transit from the stomach into the small intestine is accomplished.

Film coatings have also led to the development of delivery vehicles (e.g., tablets and capsules) having sustained-release properties. Mixtures of waxes, cellulose, silicone and similar resins have been found useful by those skilled in the art for creating-sustained release coatings. In principle, these prior art coatings function to delay the release of the active ingredient or medicament to the targeted body system, thereby facilitating a timed, absoφtion rate in the body. Furthermore, the entire daily dosage of an active or medicament may be contained in a single, sustained-release delivery vehicle (e.g., tablet or capsule), whereas the immediate absorption of the entire dosage could possibly lead to an overdosage of the medicament. Thus, by layering quanta of medicament with differential coatings, the dosage undergoes a controlled release over specified time period. The application of sustained-release film coating technology therefore may inherently facilitate the delivery of a total daily dosage amount of an active or medicament to be released to the body in controlled increments.

Over the last several years, a considerable amount of attention has been focused on the further development of multi-compartment capsule technology for the delivery of therapeutic and diagnostic agents. Series formulations teach the use of membranes or other types of barriers to cordon a line of separate chambers within a single encapsulating shell. As appreciated, the purpose of such multi-compartment delivery devices is the administration of multiple dosages. Moreover, multiple-compartment delivery mechanisms of the prior art were developed to circumvent or diminish the effects of harsh pH environments within humans. For example, the prior art contemplates a hard capsule formulation which contains three different compartments of active medicaments for administration to the vaginal and rectal areas. In preferred structure, the formulation outer, rapid-release layer may contain an active medicament and excipient; the middle, intermediate-release layer may include a powder form of active medicament; and the inner, slow-release layer may contain pellets or granules of active medicament.

Also taught in the prior art are multi-compartment capsules having groups of spheroids with pH-dependent coatings which are encapsulated within a hard gelatin shell and provided for treating female yeast infection. The first spheroid is preferably uncoated and may be in a powder form; the second spheroid may contain a pH sensitive coat; and the inner spheroid may include a pH insensitive coat.

In addition to pH-sensitive coatings, hydrogels and other gastric retention technologies have been developed by those skilled in the art in an effort to retard the progression of the delivery vehicle during enteric transit. This retarding action, presumably, allows the full amount of active medicament to be released and/or targeted to a specific area of the gastrointestinal tract. Hydrogel and related gastric retention devices of the prior art generally rely upon the imbibing of water into a center core which is filled with cellulose or similar water absorbent material. In preferred operation, the material swells and releases multiple compartments of active medicament. The concept of using bulk size to slow transit of single active medicament in a single physical state is thus appreciated.

In an effort to administer active ingredients or medicaments to a specific location in the body to treat a specific disorder caused by a specific pathogen, those skilled in the art have used targeted-release systems using multi-compartment capsular technology. For example, a method for carrying out a triple therapy against the microorganisms Helicobacter pylori, a known infectious agent which is believed largely responsible for the development of gastric ulcer disease, was developed which comprises the steps of oral administration of a pharmaeceutical dosage form comprising an internal capsule placed inside an external capsule, wherein the external capsule comprises a soluble salt of bismuth and a first antibiotic, and the internal capsule comprises a second antibiotic. In addition, multi-compartmental capsules were developed which combine a nutrient supplement with a viable direct-fed microbial (i.e., gastrointestinal microorganisms, including bacteria, live cell yeasts, fungi or a combination thereof) for the purpose of treating livestock for feeding disorders and improving feed efficiency. A disadvantage with prior art encapsulation technology is when the base and corresponding cap of a capsule are joined, dead space volume is typically created within the internal periphery of the capsule. Internal capsular dead space may be filed with an air bubble which may ultimately react with one or more ofthe active ingredients or medicaments introduced within the capsule, thereby potentially degrading the quality and effectiveness of the active ingredients.

Although the prior art discloses multiple compartment, capsular delivery technology, these manifestations generally includes one of two approaches. For example, one approach contemplates the introduction of a single active or medicament into multiple capsular compartments to vary the temporal release of the medicament and ultimately the absorption rate into the body. Another approach contemplates the introduction of a plurality of active ingredients or medicaments into different compartments of a single capsule for delivery to a specific area ofthe body to treat a targeted illness or condition.

The use or contemplation of multiple-compartment capsular delivery apparatus or methods which deliver different physical forms ofthe same active or medicament, or a variation in physical forms of different actives or medicaments in a single dosage, however, has not heretofore been contemplated in the art. As appreciated by those skilled in the art, active ingredients or medicaments may take the physical form of a solid (e.g. , pill, tablet, capsule (both hard and soft elastic), powder, granulation, flakes, troches (lozenges and pastilles), suppositories and semi-solid ointments, pastes, emulsions and creams), a liquid (e.g., solution, spirits, elixir, syrups, sprays and fluid extracts), a gas or a dispersion. A dispersion is a system in which a dispersed phase is distributed through a continuous phase (e.g., aerosols (liquid or solid in gas), suspensions (solid in liquid), emulsion (liquid in liquid), foam (gas in liquid), solid foam (solid in gas) or gel (liquid or solid in solid)). Dispersions can be classified as molecular, colloidal and coarse, depending on size. In many circumstances, however, the different physical forms or phases of more than one active ingredient or medicament may not be suitably combined or mixed together without altering the individual desirable properties ofthe active ingredient or medicament. For example, although it would be possible and desirable to formulate a dispersion by combining a first active ingredient in the solid state with a second active ingredient that exists as a liquid, adverse chemical interactions between the active ingredients may adversely affect various characteristics ofthe ingredients, including but not limited to, their shelf lives. The resulting chemical decomposition - and the potential formation of any unwanted side products - could result in diminished drug potency or even toxicity to a patient.

Additionally, the physical properties of crystalline active ingredients could be drastically altered in scenarios where it is desirable to co-administer a crystalline active ingredient with a liquid or semi-liquid different active ingredient. In this context, the control of physical properties such as active ingredient dissolution rate and solubility is often a critical factor in determining the overall bioavailability ofthe active ingredient. It is well established in the art that different polymorphs or solvates ofthe same crystalline active ingredient exhibit dramatically different solubility and dissolution rates. Thus, combining a crystalline active agent with a liquid or semi-liquid active agent could give rise to an equilibrium between concentrations of different polymorphs and/or solvates ofthe crystalline active ingredient, and thereby frustrate efforts at tailoring an active ingredient mixture to its intended purpose as a medicament.

Another shortcoming with co-administering plural active ingredients in different physical forms in an intimate mixture is the potential for adverse in vivo drug-drug interactions upon administration. The desire to co-administer these active ingredients would be offset by the one active ingredient, for example as in a liquid or semi-liquid (e.g., a paste, solution, or syrup) form, becoming rapidly available. In this context, the active ingredient may adversely react with a co-administered drug, for example a less bioavailable solid or semi-solid, in a physiological environment. Thus, the true therapeutic benefit resulting from the pharmacological effects ofthe individual active agents may never be realized. It would be desirable to co-administer plural active ingredients while insuring against the potential of such harmful drug-drug interactions.

Providing active ingredients or medicaments in separate capsules may also be undesirable in the context of patient compliance. Geriatric and pediatric populations in particular disfavor the handling and consumption of multiple capsules of active ingredients. Patient compliance is essential in maintaining patient health in many dosage regimens. For example, deviations from accurate dosing and consistent consumption of immunosuppressant therapies can result in severe or even lethal consequences for a patient. Providing combined dosages of active ingredients would result in fewer capsules a patient or consumer would have to take, and thereby contribute to an overall increase in compliance.

Therefore, it would be desirable to provide a multi-compartment capsular delivery apparatus and methods that provide active ingredients or medicaments having diverse physical properties (e.g., solid, liquid, gas or dispersion), which may or may not be properly combined or stored together into a unitary structure (i.e., multi-compartment capsule) for usage in a single dosage form. The present invention, in overcoming the shortcomings ofthe prior art, satisfies these and other objectives. The art and practice of pharmacy can be divided into four distinct divisions. Pharmacology is the study of interactions occurring between the pharmacologic agent, or medicament and specific targeted cells in the body. More specifically, the interaction between an active agent and a cellular receptor along with the resulting change in cell physiology is examined. Medicinal chemistry is largely concerned with the identification of naturally occurring and synthetic compounds which possess medicinal characteristics.

Pharmacotherapeutics is the holistic application of pharmacy practice to specific pathologies, illnesses, and other body functions. Finally, Pharmaceutical science ascertains or regulates the composition of medicinal substances, and is largely directed to the development of new mechanisms for delivering chemicals and biomolecules into animals and humans. A subcategory of pharmaceutical science is called pharmacokinetics and sometimes generally referred to as biopharmaceutics.

A.D.M.E. is an acronym often used to describe the four essential components to pharmaceutical science: absorption, distribution, metabolism, and elimination, respectively. One way to differentiate between pharmacology and pharmaceutical science is that the former is primarily concerned with the effect of the medicament on the body, whereas, the latter is primarily concerned with the delivery and time-course of the medicament on its journey through the body.

In clinical applications, chemicals and biomolecules are often referred to as active ingredients or medicaments. Medicaments may include "pharmaceuticals, nutraceuticals, biotechnicals, vitamins, minerals and dietary supplements." Oral administration is the most frequent route for delivery of medicaments. Medicaments may be orally administered in a variety of physical states, including, solid, liquid, dispersion, and gaseous forms. As appreciated, tablets and capsules are the most common vehicle for oral delivery of medicaments.

Frequently, a medical or surgical patient may receive a plurality of concurrent medicaments. Data has been accumulated to demonstrate that patients undergoing a surgical procedure may receive ten (10) or more medicaments during the surgery and the resulting surgical recovery period. Some patients who have undergone organ transplantation or who have contracted human immunodeficiency virus (HIV) may receive three (3) or more medicaments which require multiple administrations per day. HIV patients often receive many more than three (3) medicaments. These medicaments may be necessary for the treatment of several conditions occurring in a plurality of organ systems or they may be necessary to treat a single condition or some combination thereof.

In some cases, it may be desirous to combine a plurality of medicaments because of a synergistic interaction between a plurality of medicaments. This synergy may enhance the efficacy of one or more of the medicaments. Medicaments may be combined to increase the intensity of response or efficacy. A plurality of medicaments, in combination, may be homergic (i.e. , ellicit the same quality of effect). In many cases, a plurality of homergic medicaments may also be homodynamic (i.e. , interact with the same receptor). A plurality of homergic medicaments may be additive, supra-additive and infra-additive. A plurality of combined medicaments which do not produce the same quality of response may be called, heterergic. When heterergy is found to be a positive effect (i.e., at least one medicament enhances the response to another medicament), this may be called synergism and is sometimes called synergy.

In further cases, it maybe desirous to combine a plurality of medicaments to decrease their individual dosages and possibility for toxicity. It may also be desirous to combine a plurality of medicaments to target the treatment of a disease, illness or condition from divergent angles. It may be desirous to combine a plurality of medicaments to minimize the side effects and adverse effects of one or more medicaments. It may be still further desirous to combine a plurality of medicaments to alter the pharmacokinetic characteristics of one or more medicaments. For example, alterations in the absorption, distribution, metabolism or elimination of one or more medicaments.

Fixed combinations of a plurality of medicaments have been generally disfavored due to any number of perceived disadvantages. These disadvantages may include, for example: (1) complicating the interpretation of safety and efficacy in therapeutic regimens, (2) there may be inter-patient differences to fixed combinations, (3) there may be difficulties in dosage titration, and (4) the delivery platforms for fixed combinations have generally been found to be uneconomical to produce. On the other hand, fixed combinations of a plurality of medicaments may lead to several therapeutic advantages, including, for example, but not by way of limitation: (1) increasing patient compliance with therapy, (2) increasing efficacy by optimizing timing of medicaments, (3) minimization of side effects and adverse effects, (4) enhancement of pharmacokinetic characteristics of one or more medicaments in a fixed combination, (5) increased patient quality of life, (6) optimization of institutional resources by minimizing the amount of medicament administrations, and (7) minimizing patient length of stay in institutional facilities by optimizing therapy.

Prior art therapeutic technologies contain isolated examples of pharmaceutical formulations containing fixed combinations of medicaments. However, therapeutic technologies of the prior art teach a fixed combination, wherein a plurality of medicaments are placed into a single receiving chamber in the delivery formulation (i.e., no separation between the plurality of medicaments).

In view of the state of the technology as it exists today, generally, therapeutic apparatus and methods are needed to provide a plurality of medicaments for medical and surgical conditions, as well as maintenance of normal health function for delivery to animals and humans using a multi-chambered delivery apparatus. Such apparatus and methods for delivering a plurality of medicaments to animals and humans using a multi- chambered delivery apparatus are contemplated herein.

BRIEF SUMMARY AND OBJECTS OF THE INVENTION

In view of the foregoing, it is a primary object of the present invention to provide novel integrated capsule delivery apparatus and methods for delivering diverse physical states (e.g., solid, liquid, gas or dispersion) of a single active ingredient or medicament, or a plurality of active ingredients or medicaments, in a single dosage form, wherein at least two ofthe active ingredients or medicaments have physical states that differ.

It is also an object of the present invention to provide novel integrated capsule delivery apparatus and methods which facilitate various desirable properties including, for example, controlling time-release of key active ingredients or medicaments, prolonging shelf-life of the active ingredients or medicaments, improving palatability, reducing overall production costs and, accordingly, reducing the number of capsules consumed by a patient or consumer as nutritional or therapeutic agents. Further, it is an object of the present invention to provide novel integrated capsule delivery apparatus and methods for delivering one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) in the form of a single dosage, multi-compartment capsule having one or more active ingredients in a primary capsule, and one or more active ingredients introduced into a secondary smaller capsule having a size sufficient for being selectively positionable within the primary capsule, wherein the active ingredient(s) within the primary capsule comprises a physical state (e.g., solid, liquid, gas or dispersion) that is different from the physical state ofthe active ingredient(s) in the secondary capsule.

It is an additional object of the present invention to provide novel integrated capsule delivery apparatus and methods for delivering one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) in the form of a single dosage, multi-compartment capsule having one or more active ingredients in a primary capsule and the same active ingredient(s) introduced into a smaller secondary capsule having a size sufficient for being positionable within the primary capsule, wherein the active ingredient(s) in the primary capsule comprises a physical state (e.g., solid, liquid, gas or dispersion) different from the active ingredient(s) in the secondary capsule.

It is a further object of the present invention to provide novel integrated capsule delivery apparatus and methods for delivering one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) in the form of a single dosage, multi-compartment capsule wherein at least one ofthe primary and secondary capsules include a time-release coating for controlling the release ofthe active ingredient(s) contained therein. It is also another object of the present invention to provide novel integrated capsule delivery apparatus and methods for delivering one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) in the form of a single dosage, multi-compartment capsule having one or more active ingredients in the capsular body, wherein the capsule includes a longitudinally extending body and at least one dividing wall formed along a length ofthe extending body to form a first chamber and an opposing second chamber within the capsular body and introducing at least one active ingredient or medicament having a first physical state into the first chamber and at least one active ingredient or medicament having a second physical state into a second chamber, whereas the physical state (e.g., solid, liquid, gas or dispersion) ofthe ingredient(s) in the first chamber is different from the physical state ofthe ingredient(s) in the second chamber.

It is an additional object of the present invention to provide novel integrated capsule delivery apparatus and methods for delivering one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) in the form of a single dosage, multi-compartment capsule having a longitudinally extending body and one or more dividing walls disposed along the length of the longitudinally extending body ofthe capsule, wherein the capsule and one or more of the dividing walls contained therein may include time-release coatings for controlling the release ofthe active ingredients or medicaments contained therein, respectively.

It is a further object of the present invention to provide novel integrated capsule delivery apparatus and methods for delivering one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) in the form of a single dosage, multi-compartment capsule having a plurality of active ingredients or medicaments having the physical form of a solid (e.g., pill, tablet, capsule (both hard and soft elastic), powder, granulation, flakes, troches (lozenges and pastilles), suppositories and semi-solid ointments, pastes, emulsions and creams), a liquid (e.g., solution, spirits, elixir and fluid extracts), a gas or a dispersion (e.g., aerosols (liquid or solid in gas), suspensions (solid in liquid), emulsion (liquid in liquid), foam (gas in liquid), solid foam (solid in gas) or gel (liquid or solid in solid), wherein the physical form of the active ingredients differ between a primary and secondary capsule, and between one or more dividing walls disposed in spaced-apart relationship along the length of a longitudinally extending capsular body.

It is a still further object of the present invention to provide novel integrated capsule delivery apparatus and methods for delivering one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) in the form of a single dosage, multi-compartment capsule, wherein an encapsulation process comprises the steps of: (1) providing a capsule comprising a first end, a second end, a longitudinally extending body having a length disposed between the first and second ends, and a plurality of dividing walls spaced apart along the length of the extending body, wherein the dividing walls form a plurality of receiving chambers; (2) introducing at least one active ingredient having a first physical state into a first receiving chamber; (3) introducing at least one active ingredient having a second physical state into a second receiving chamber; (4) introducing at least one active ingredient having a third physical state into a third receiving chamber, wherein the physical states of at least two of the active ingredients introduced into the first, second or third receiving chambers differ; and (5) sealing the first and second ends of said capsule. Additionally, it is an object of the present invention to provide novel integrated capsule delivery apparatus and methods for delivering a single dosage, multi-compartment capsule comprising a capsular base and cap configuration, wherein the size and shape of the cap, relative to its sealing relationship with the base, generally eliminates or substantially reduces any potential dead space volume within the internal periphery ofthe capsule, thereby functionally negating the opportunity for reaction between an air bubble and one or more active ingredients introduced into the capsule and, accordingly, improving stability of the capsular ingredient(s). Consistent with the foregoing objects, and in accordance with the invention as embodied and broadly described herein, one presently preferred embodiment of the novel integrated capsule delivery apparatus and methods of the present invention comprises a multi-compartment capsule including a primary capsule and a secondary capsule selectively positionable within an internal periphery ofthe primary capsule. The secondary capsule may include a base, a corresponding cap and one or more receiving chambers. Each of the receiving chambers of the secondary capsule may be formed having an internal periphery sufficient for receiving at least one active ingredient or medicament (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) therein. Similarly, the primary capsule may be formed having a base, a corresponding cap and one or more receiving chambers. The receiving chambers ofthe primary capsule may be formed having an internal periphery sufficient for receiving the secondary capsule and one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) having a physical state (i.e., solid, liquid, gas or dispersion) different from the physical state of the active ingredient(s) housed within the receiving chamber ofthe secondary capsule.

As further contemplated herein, a multi-compartment capsule is provided comprising a base, a corresponding cap and one or more dividing walls positionable between the base and the cap. Structurally, the size, shape and positioning ofthe dividing walls relative to the base and corresponding cap facilitates the formation of at least two, independent and separate receiving chambers. Each of the receiving chambers having an internal periphery sufficient for receiving one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) therein. In preferred design, the physical state (e.g., solid, liquid, gas or dispersion) of the active ingredient(s) in the first receiving chamber is different from the physical state of the active ingredient(s) in the second receiving chamber. After introducing one or more active ingredients or medicaments into each receiving chamber, the cap may be selectively positioned in sealing relationship with the base to form one presently preferred embodiment ofthe single, dosage multi-compartment capsule.

One presently preferred embodiment of an encapsulation process for forming a multi-compartment capsule may comprise the steps of: (1) providing a primary capsule having a base, a corresponding cap and a receiving chamber; (2) providing a secondary capsule having a base, a corresponding cap and a receiving chamber; (3) introducing at least one ingredient or medicament (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) having a first physical state (e.g., solid, liquid, gas or dispersion) into at least a portion of the receiving chamber of the secondary capsule and selectively positioning the cap in sealing relationship with the base; (4) introducing at least one ingredient or medicament (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) having a second physical state (e.g., solid, liquid, gas or dispersion) into at least a portion of the receiving chamber of the primary capsule, wherein the first physical state of the ingredient(s) in the secondary capsule is different from the second physical state of the ingredient(s) in the primary capsule; and (5) introducing the secondary capsule into at least a portion of the receiving chamber of the primary capsule and selectively positioning the cap in sealing relationship with the base to form a single dosage multi-compartment capsule.

In alternate presently preferred embodiments of the present invention, a tertiary capsule comprising a base, a corresponding cap and a receiving chamber having an internal periphery sufficient for receiving one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) may be selectively introduced within an internal periphery of at least one receiving chamber ofthe secondary capsule. After the introduction of at least one active ingredient into one or more receiving chambers of a tertiary capsule pursuant to an encapsulation process of the present invention, the cap of the tertiary capsule may be selectively positioned in sealing relationship with the base and then introduced into at least a portion of the internal periphery of the secondary capsule, together with one or more active ingredients therein. It is contemplated herein that at least two of the active ingredients introduced within the receiving chambers of the primary, secondary and tertiary capsules, respectively, comprise at least two different physical states (e.g., solid, liquid, gas or dispersion). In preferred structural design, the primary capsule may comprise a cap having a generally U-shaped configuration adapted to provide a sealing relationship when engaging the corresponding base, thereby reducing dead space volume in the internal periphery of the cap and receiving chamber of the base. A cap having a configuration adapted to generally eliminate or substantially reduce potential dead space volume of the cap and receiving chamber ofthe base may, accordingly, function to negate the potential for a reaction between an air bubble and one or more active ingredient(s) introduced into the base of the primary capsule.

Alternatively, a multi-compartment capsule of the present invention may include the introduction of a filling material into the cap ofthe primary capsule, the cap having a general cylindrical configuration adapted to provide a sealing relationship when engaging the corresponding base. An amount of filling material may be introduced into at least a portion of the internal periphery ofthe cap to fill, either partially or completely, the inner volume of the cap, thereby reducing the dead space volume in the cap and the internal periphery of the receiving chamber ofthe base. In this regard, the introduction of a filling material relative to the internal periphery ofthe cap may generally eliminate or substantially reduce the potential dead space volume, thus functionally negating the potential for a reaction between an air bubble and one or more active ingredient(s) introduced into the base ofthe primary capsule.

The primary, secondary or tertiary capsules, in accordance with the present invention, may be formed having the same or different colors. Moreover, the base and corresponding cap of a single capsule may be formed having different colors in an effort to enhance the aesthetics of the capsule to the consumer. In one presently preferred embodiment of a multi-compartment capsule of the present invention, the dosage may be banded, sealed or easily dividable in a contact area of the primary and secondary capsules or the sealing band may be color-coded to assist in branding, if desired.

It is further contemplated herein that a multi-compartment capsule of the present invention may comprise component parts of the capsule having various time-release coatings to facilitate the release and ultimately the absoφtion of those active ingredients introduced into the different receiving chambers of the multi-compartment capsule to release at different release rates. In particular, a primary capsule may be formed having a conventional time-release coating that dissolves and releases the active ingredient(s) contained therein before the timed-release of the active ingredient(s) contained within a secondary capsule. Likewise, the dividing walls disposed within the internal periphery of the base of a capsule may be formed having conventional time-release coatings that dissolve and release the active ingredients within each receiving chamber defined by the dividing walls at different rates, thereby delivering the active ingredients or medicaments contained within a multi-compartment capsule at different rates. Certain active ingredients or medicaments may, therefore, be delivered at a selected interval, while other ingredients may be released at a later interval, hi this way, the novel design of the multi-compartment capsules of the present invention may facilitate precision delivery of active ingredients to targeted areas of the consumer.

Still further, a primary object of the present invention is to provide novel delivery apparatus and methods for affecting multiple organ systems in animals or humans using a plurality of medicaments delivered by a pharmaceutical formulation comprising a multi- chambered apparatus. Accordingly, the present invention provides novel delivery apparatus and administration techniques or methods aimed at affecting multiple organ systems in an animal or human using a plurality of medicaments. A delivery apparatus may be in any multi-chambered apparatus, but preferably in a capsular formulation. Thus, a plurality of medicaments may be encapsulated and stored separately within a larger capsule until the time of ingestion, consumption, or the like. Upon consumption, the capsule walls of one or more dividing walls of a capsule may dissolve to release their contents. Different methods of encapsulation may be used to deliver their respective contents, including but not limited to, dissolution, melting, ablation or biodegradation of the encapsulating wall. In certain embodiments and as contemplated herein, the medicaments retained in the multicompartment capsule may actually diffuse through one or more of the encapsulating walls.

In one embodiment ofthe present invention there is a multi-compartment capsule, comprising a first receiving chamber comprising at least one ingredient having a first physical state, wherein said ingredient is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral; and a second receiving chamber comprising at least one ingredient having a second physical state, wherein said ingredient is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral; said first physical state of said ingredient of said first receiving chamber being different from said second physical state of said ingredient of said second receiving chamber.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, further comprising a base and a corresponding cap, wherein said cap is configured to provide a sealing relationship when engaging said base.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said cap comprises a configuration adapted to reduce dead volume space within said first receiving chamber.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, further comprising a filling material introduced into said cap to reduce dead volume space within said first receiving chamber.

h another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said filling material is selected from the group consisting of gelatin, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl methyl cellulose, oleoresin, polyvinylacetate-phtalate, polymerisates of acrylic or methacrylic esters and combinations thereof. In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said first receiving chamber comprises no dead volume space.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said physical state of said ingredient in said first receiving chamber is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said physical state of said ingredient in said second receiving chamber is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said solid is selected from the group consisting of a pill, a tablet, a capsule, a powder, granulation, flakes, a troche, a suppository, an ointment, a paste, an emulsion and a cream.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said liquid is selected from the group consisting of a solution, a spirit, an elixir, a spray, a syrup and a fluid extract.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said dispersion is selected from the group consisting of an aerosol, a suspension, an emulsion, a foam, a solid foam and a gel.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said first receiving chamber comprises a time-release coating.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said second receiving chamber comprises a time-release coating.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said time-release coating of said second receiving chamber is different from said time-release coating of said primary capsule.

hi another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, further comprising a third receiving chamber comprising at least one ingredient. In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said ingredient in said third receiving chamber is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said ingredient in said third receiving chamber comprises a physical state selected from the group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said third receiving chamber comprises a time-release coating.

In another embodiment ofthe present invention, there is a multi-compartment capsule, comprising a primary capsule comprising at least one ingredient having a first physical state, wherein said ingredient is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral; a secondary capsule comprising at least one ingredient having a second physical state, wherein said ingredient is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral; said first physical state of said ingredient of said primary capsule being different from said second physical state of said ingredient of said secondary capsule; and said primary capsule comprising an internal periphery sufficient for receiving said ingredient and said secondary capsule therein.

h another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said primary capsule further comprises a base and a corresponding cap, wherein said cap is configured to provide a sealing relationship when engaging said base.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said primary capsule comprises no dead volume space.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said first physical state of said ingredient in said primary capsule is selected from the group consisting of a solid, a liquid, a gas and a dispersion. In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said second physical state of said ingredient in said secondary capsule is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said primary capsule comprises a time-release coating.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said secondary capsule comprises a time-release coating.

h another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said time-release coating of said secondary capsule is different from said time-release coating of said primary capsule.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said primary capsule is formed of a material selected from the group consisting of gelatin, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, oleoresin, polyvinylacetate, hydroxypropyl methyl cellulose, polymerisates of acrylic or methacrylic esters, polyvinylacetate-phtalate and combinations thereof.

hi another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said primary capsule further comprises a soft elastic capsule formed of a material selected from the group consisting of glycerin and sorbitol.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said soft elastic capsule includes an antimicrobial selected from the group consisting of paraben and sorbic acid.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said secondary capsule is formed of a material selected from the group consisting of gelatin, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, oleoresin, polyvinylacetate, hydroxypropyl methyl cellulose, polymerisates of acrylic or methacrylic esters, polyvinylacetate-phtalate and combinations thereof.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said ingredient introduced in said primary capsule comprises a moisture content in the range of about 0% to 6% by weight.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said ingredient introduced in said secondary capsule comprises a moisture content in the range of about 0% to 6% by weight.

hi another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said primary and secondary capsules contain at least one pharmaceutically acceptable lubricant in the range of about 0% to 10% by weight.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said lubricant is selected from the group consisting of aluminiurnstearate, calciumstearate, magnesiumstearate, tinstearate, talc, sodium lauryl sulfate, lecithins, mineral oils, stearic acid, silicones and mixtures thereof.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said primary and secondary capsules have different colors.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said primary capsule is formed having a first color.

h another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said secondary capsule is formed having a second color different from said first color of said primary capsule.

hi another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said capsule further comprises a base and a corresponding cap, wherein said cap is configured to provide a sealing relationship when engaging said base. In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said base and said cap are formed having different colors.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said sealing relationship between said base and corresponding cap comprises no dead volume space.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said physical state of said ingredient in said second receiving chamber capsule is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said capsule comprises a time-release coating.

hi another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said dividing wall comprises a time-release coating.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said time-release coating of said dividing wall is different from said time-release coating of said capsule.

hi another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said third receiving chamber comprises a time-release coating.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said capsule is formed of a material selected from the group consisting of gelatin, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, oleoresin, polyvinylacetate, hydroxypropyl methyl cellulose, polymerisates of acrylic or methacrylic esters, polyvinylacetate-phtalate and combinations thereof. In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said capsule further comprises a soft elastic capsule formed of a material selected from the group consisting of glycerin and sorbitol.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said dividing wall is formed of a material selected from the group consisting of gelatin, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, oleoresin, polyvinylacetate, hydroxypropyl methyl cellulose, polymerisates of acrylic or methacrylic esters, polyvinylacetate-phtalate and combinations thereof.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said ingredient introduced in said first receiving chamber comprises a moisture content in the range of about 0% to 6% by weight.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said ingredient introduced in said second receiving chamber comprises a moisture content in the range of about 0% to 6% by weight.

h another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said capsule contains at least one pharmaceutically acceptable lubricant in the range of about 0% to 10% by weight.

h another embodiment ofthe present invention there is, an encapsulation process for forming a multi-compartment capsule, said process comprising the steps of providing a primary capsule having a base and a cap; providing a secondary capsule having a base and a cap; introducing at least one ingredient having a first physical state into said secondary capsule, wherein said ingredient introduced into said primary capsule is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral; positioning said cap of said secondary capsule in sealing relationship with said base; introducing at least one ingredient having a second physical state into said primary capsule, wherein said ingredient introduced into said primary capsule is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral; and wherein said first physical state of said ingredient of said secondary capsule is different from said second physical state of said ingredient of said primary capsule; introducing said secondary capsule into said base of said primary capsule; and positioning said cap of said primary capsule in sealing relationship with said base.

h another embodiment ofthe present invention there is, an encapsulation process as defined above, further comprising the step of reducing dead volume space within said primary capsule.

h another embodiment ofthe present invention, an encapsulation process as defined above, further comprising the step of introducing a filling material into said cap of said primary capsule to reduce dead volume space.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said filling material is selected from the group consisting of gelatin, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl methyl cellulose, oleoresin, polyvinylacetate-phtalate, polymerisates of acrylic or methacrylic esters and combinations thereof.

In another embodiment ofthe present invention, an encapsulation process as defined above, wherein said cap of said primary capsule comprises a configuration sufficient for reducing dead volume space within the primary capsule.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said physical state of said ingredient in said primary capsule is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said physical state of said ingredient in said secondary capsule is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said ingredient introduced into said primary capsule is the same as said ingredient introduced into said secondary capsule.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said primary capsule comprises a time-release coating. In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said secondary capsule comprises a time-release coating.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said time-release coating of said secondary capsule is different from said time-release coating of said primary capsule.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, further comprising the steps of providing a tertiary capsule having a base and a cap; introducing at least one ingredient having a third physical state into said tertiary capsule; positioning said cap of said secondary capsule in sealing relationship with said base; and introducing said tertiary capsule into said base of said secondary capsule.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said ingredient in said tertiary capsule is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said ingredient in said tertiary capsule comprises a physical state selected from the group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said tertiary capsule comprises a time-release coating.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said primary capsule is formed of a material selected from the group consisting of gelatin, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl methyl cellulose, oleoresin, polymerisates of acrylic or mthacrylic esters, polyvinylacetate-phtalate and combinations thereof.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said primary capsule further comprises a soft elastic capsule formed of a material selected from the group consisting of glycerin and sorbitol. In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said secondary capsule is formed of a material selected from the group consisting of gelatin, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl methyl cellulose, oleoresin, polymerisates of acrylic or mthacrylic esters, polyvinylacetate-phtalate and combinations thereof.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said secondary capsule further comprises a soft elastic capsule formed of a material selected from the group consisting of glycerin and sorbitol.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said ingredient introduced in said primary capsule comprises a moisture content in the range of about 0% to 6% by weight.

hi another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said primary and secondary capsules contain at least one pharmaceutically acceptable lubricant in the range of about 0% to 10% by weight.

h another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said lubricant is selected from the group consisting of aluminiurnstearate, calciumstearate, magnesiumstearate, tinstearate, talc, sodium lauryl sulfate, lecithins, mineral oils, stearic acid, silicones and combinations thereof.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said primary and secondary capsules are formed having different colors.

In another embodiment ofthe present invention, there is an encapsulation process for forming a multi-compartment capsule, said process comprising the steps of providing a capsule comprising a cap, a base configured having a longitudinally extending body including a length and at least one dividing wall formed along said length of said extending body, said dividing wall adapted to form a first receiving chamber and a second receiving chamber; introducing at least one ingredient having a first physical state into said second receiving chamber, wherein said ingredient introduced into said primary capsule is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral; introducing at least one ingredient having a second physical state into said first receiving chamber, wherein said ingredient introduced into said primary capsule is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral, and wherein said first physical state of said ingredient of said second receiving chamber being different from said second physical state of said ingredient of said first receiving chamber; and positioning said cap in sealing relationship with said base.

h another embodiment ofthe present invention, there is an encapsulation process as defined above, further comprising the step of reducing dead volume space within said primary capsule.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, further comprising the step of introducing a filling material into said cap to reduce said dead volume space.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said cap comprises a configuration sufficient for reducing dead volume space within said capsule.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said physical state of said ingredient in said receiving chamber is selected from the group consisting of a solid, a liquid, a gas and a dispersion. In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said physical state of said ingredient in said second receiving chamber is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said first receiving chamber comprises a time-release coating.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said second receiving chamber comprises a time-release coating.

hi another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said time-release coating of said second receiving chamber is different from said time-release coating of said first receiving chamber.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, further comprising the steps of positioning a second dividing wall along said length of said extending body, said second dividing wall adapted to form a third receiving chamber; and introducing at least one ingredient having a third physical state into said third receiving chamber.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said ingredient in said third receiving chamber is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said ingredient in said third receiving chamber comprises a physical state selected from the group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said dispersion is selected from the group consisting of an aerosol, a suspension, an emulsion, a foam, a solid foam and a gel.

hi another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said third receiving chamber comprises a time-release coating.

h another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said capsule is formed of a material selected from the group consisting of gelatin, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl methyl cellulose, oleoresin, t polymerisates of acrylic or mthacrylic esters, polyvinylacetate-phtalate and combinations thereof.

h another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said capsule further comprises a soft elastic capsule formed of a material selected from the group consisting of glycerin and sorbitol.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said primary and secondary capsules contain at least one pharmaceutically acceptable lubricant in the range of about 0% to 10% by weight.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said lubricant is selected from the group consisting of aluminiurnstearate, calciumstearate, magnesiumstearate, tinstearate, talc, sodium lauryl sulfate, lecithins, mineral oils, stearic acid, silicones and combinations thereof.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said base and said cap of said capsule are formed having different colors.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, further comprising the step of introducing two or more dividing walls adapted to form a plurality of receiving chambers into said base of said capsule.

hi another embodiment ofthe present invention, there is an encapsulation process as defined above, further comprising the step of introducing a capsule into one of said plurality of receiving chambers.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said capsule may comprise a multi-compartment capsule.

In another embodiment ofthe present invention, there is a multi-compartment capsule, comprising a first receiving chamber comprising at least one ingredient having a first physical state; and a second receiving chamber comprising at least one ingredient having a second physical state, wherein said first physical state of said ingredient of said first receiving chamber being different from said second physical state of said ingredient of said second receiving chamber.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said first receiving chamber comprises no dead space.

hi another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said cap is configured to reduce dead volume space within said first receiving chamber.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said ingredient in said first receiving chamber is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

h another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said ingredient in said second receiving chamber is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

h another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said ingredient in said first receiving chamber comprises a pharmaceutical and said ingredient in said second receiving chamber comprises a pharmaceutical.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said ingredient in said first receiving chamber comprises a pharmaceutical and said ingredient in said second receiving chamber is selected from the group consisting of a biotechnical, a nufraceutical, a vitamin, a dietary supplement and a mineral. In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said physical state of said ingredient in said first receiving chamber is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

hi another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said physical state of said ingredient in said second receiving chamber is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment ofthe present invention, there is a multi-compartment capsule, comprising a primary capsule comprising at least one ingredient having a first physical state; a secondary capsule comprising at least one ingredient having a second physical state; said first physical state of said ingredient of said primary capsule being different from said second physical state of said ingredient of said secondary capsule; and said primary capsule comprising an internal periphery sufficient for receiving said ingredient and said secondary capsule therein.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said primary capsule further comprises a base and a conesponding cap, wherein said cap is configured to provide a sealing relationship when engaging said base.

h another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said ingredient in said primary capsule is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said ingredient in said secondary capsule is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

hi another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said ingredient in said first receiving chamber comprises a pharmaceutical and said ingredient in said second receiving chamber comprises a pharmaceutical.

h another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said ingredient introduced in said primary capsule comprises a moisture content in the range of about 0% to 6% by weight.

h another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said primary and secondary capsules contain at least one pharmaceutically acceptable lubricant in the range of about 0% to 10% by weight.

h another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said primary and secondary capsules have different colors.

h another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said primary capsule is formed having a first color.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said secondary capsule is formed having a second color different from said first color of said primary capsule.

hi another embodiment ofthe present invention, there is a multi-compartment capsule, comprising a capsule comprising a longitudinally extending body having a length; at least one dividing wall formed along said length of said extending body, said dividing wall forming a first receiving chamber and a second receiving chamber; said first receiving chamber comprising at least one ingredient having a first physical state; said second receiving chamber comprising at least one ingredient having a second physical state; and said first physical state of said ingredient of said first receiving chamber being different from said second physical state of said ingredient of said second receiving chamber.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said capsule further comprises a base and a corresponding cap, wherein said cap is configured to provide a sealing relationship when engaging said base.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said base and said cap are formed having different colors.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said sealing relationship between said base and conesponding cap comprises no dead volume space within said capsule.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said ingredient in said first receiving chamber comprises a pharmaceutical and said ingredient in said second receiving chamber comprises a pharmaceutical.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said ingredient in said first receiving chamber comprises a pharmaceutical and said ingredient in said second receiving chamber is selected from the group consisting of a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said first physical state of said ingredient in said first receiving chamber is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said second physical state of said ingredient in said second receiving chamber capsule is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

h another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said capsule comprises a time-release coating.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined in above, wherein said capsule is formed of a material selected from the group consisting of gelatin, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl methyl cellulose, oleoresin, polymerisates of acrylic or methacrylic esters, polyvinylacetate-phtalate and mixtures thereof.

In another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said capsule further comprises a soft elastic capsule formed of a material selected from the group consisting of glycerin and sorbitol.

h another embodiment ofthe present invention, there is a multi-compartment capsule as defined above, wherein said lubricant is selected from the group consisting of aluminiurnstearate, calciumstearate, magnesiumstearate, tinstearate, talc, sodium lauryl sulfate, lecithins, mineral oils, stearic acid, silicones and mixtures thereof.

. hi another embodiment ofthe present invention, there is an encapsulation process for forming a multi-compartment capsule, said process comprising the steps of providing a primary capsule having a base and a cap; providing a secondary capsule having a base and a cap; introducing at least one ingredient having a first physical state into said secondary capsule; positioning said cap of said secondary capsule in sealing relationship with said base; introducing at least one ingredient having a second physical state into said primary capsule, wherein said first physical state of said ingredient of said secondary capsule is different from said second physical state of said ingredient of said primary capsule; introducing said secondary capsule into said base of said primary capsule; and positioning said cap of said primary capsule in sealing relationship with said base.

h another embodiment ofthe present invention, there is an encapsulation process as defined above, further comprising the step of reducing dead volume space within said primary capsule. In another embodiment ofthe present invention, there is an encapsulation process as defined above, further comprising the step of introducing a filling material into said cap of said primary capsule to reduce dead volume space.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said cap of said primary capsule comprises a configuration sufficient for reducing dead volume space within the primary capsule.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said ingredient introduced into said primary capsule is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said ingredient in said secondary capsule is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

h another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said physical state of said ingredient in said secondary capsule is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said ingredient in said primary capsule comprises a pharmaceutical and said ingredient in said secondary capsule is selected from the group consisting of a pharmaceutical.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said ingredient in said primary capsule comprises a pharmaceutical and said ingredient in said secondary capsule is selected from the group consisting of a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral. In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said ingredient introduced into said primary capsule is the same as said ingredient introduced into said secondary capsule.

h another embodiment ofthe present invention, there is an encapsulation process as defined above, further comprising the steps of providing a tertiary capsule having a base and a cap; introducing at least one ingredient having a third physical state into said tertiary capsule; positioning said cap of said secondary capsule in sealing relationship with said base; and introducing said tertiary capsule into said base of said secondary capsule.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said ingredient in said tertiary capsule is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

h another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said ingredient in said tertiary capsule comprises a physical state selected from the group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment ofthe present invention, there is an encapsulation process for forming a multi-compartment capsule, said process comprising the steps of providing a capsule comprising a cap, a base configured having a longitudinally extending body including a length and at least one dividing wall formed along said length of said extending body, said dividing wall adapted to form a first receiving chamber and a second receiving chamber; introducing at least one ingredient having a first physical state into said second receiving chamber; introducing at least one ingredient having a second physical state into said first receiving chamber, wherein said first physical state of said ingredient of said second receiving chamber being different from said second physical state of said ingredient of said first receiving chamber; and positioning said cap in sealing relationship with said base.

h another embodiment ofthe present invention, there is an encapsulation process as defined above, further comprising the step of reducing dead volume space within said primary capsule. i In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said filling material is selected from the group consisting of gelatin, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl methyl cellulose, polyvinylacetate-phtalate, polymerisates of acrylic or methacrylic esters and combinations thereof.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said ingredient in said first receiving chamber is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said physical state of said ingredient in said receiving chamber is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said ingredient in said second receiving chamber is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said physical state of said ingredient in said second receiving chamber is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said ingredient in said first receiving chamber comprises a pharmaceutical and said ingredient in said second receiving chamber is selected from the group consisting of a pharmaceutical.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, further comprising the steps of positioning a second dividing wall along said length of said extending body of said base, said second dividing wall adapted to form a third receiving chamber; and introducing at least one ingredient having a physical state into said third receiving chamber.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said ingredient introduced into said third receiving chamber is selected from the group consisting of a pharmaceutical, a biotechnical, a nufraceutical, a vitamin, a dietary supplement and a mineral.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said physical state of said ingredient introduced into said third receiving chamber is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said second dividing wall comprises a time-release coating. In another embodiment ofthe present invention, there is an encapsulation process as defined above, wherein said capsule further comprises a soft elastic capsule formed of a material selected from the group consisting of glycerin and sorbitol.

BRIEF DESCRIPTION OF THE DRAWINGS The foregoing and other objects and features of the present invention will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only typical embodiments of the invention and are, therefore, not to be considered limiting of its scope, the invention will be described with additional specificity and detail through use ofthe accompanying drawings in which:

Figure 1 is a flow diagram illustrating one presently prefened embodiment of a process of the present invention comprising the steps of introducing at least one active ingredient or medicament having a solid physical state into a secondary capsule and introducing the secondary capsule into a primary capsule further including at least one active ingredient or medicament having a liquid physical state;

Figure 2 is a cross-sectional view illustrating another presently prefened embodiment of a multi-compartment capsule of the present invention wherein a primary capsule houses a secondary capsule and a secondary capsule houses a tertiary capsule, wherein each of the capsules include one or more active ingredients or medicaments and the active ingredient(s) introduced into at least two ofthe capsules comprise different physical states; Figure 3 is a perspective view illustrating yet another presently prefened embodiment of a multi-compartment capsule comprising a base, a cap and a dividing wall positioned between the base and the cap, wherein the dividing wall facilitates the formation of at least two, independent receiving chambers for receiving one or more active ingredients or medicaments having different physical states;

Figure 4 is a cross-sectional view of the multi-compartment capsule shown in Figure 3 wherein the base, the dividing wall defining the two receiving chambers and the cap are assembled to form a capsule of the present invention and wherein one or more active ingredients or medicaments having different physical states are introduced into the receiving chambers;

Figure 5 is a perspective view illustrating an alternate presently prefened embodiment of a multi-compartment capsule ofthe present invention having a primary capsule comprising a capsular base configured with a longitudinally extending body, a conesponding cap and a series of dividing walls disposed in spaced apart relationship along the length of the longitudinally extending body of the base, wherein the dividing walls define a plurality of independent receiving chambers having an internal periphery sufficient for introducing one or more active ingredients or medicaments having different physical states therein and for introducing a secondary capsule, having one or more active ingredients contained therein, within at least one of said receiving chambers; Figure 6 is a cross-sectional view of the multi-compartment capsule shown in Figure

5 wherein the base and the cap are assembled to form a single dosage capsule having a series of dividing walls that define a plurality of chambers for receiving one or more active ingredients or medicaments, wherein the active ingredient(s) in at least two of the receiving chambers comprise different physical states; Figure 7 is a perspective view illustrating yet another presently prefened embodiment of a multi-compartment capsule ofthe present invention having a primary capsule comprising a capsular base configured with a longitudinally extending body, a conesponding cap and a series of dividing walls disposed in spaced apart relationship, both vertically and horizontally, along the length of the longitudinally extending body of the base, wherein the dividing walls define a plurality of independent receiving chambers having an internal periphery sufficient for introducing one or more active ingredients or medicaments having different physical states therein; Figure 8 is a perspective view illustrating an alternate prefened embodiment of the multi-compartment capsule shown in Figure 7, wherein the multi-compartment capsule includes a primary capsule comprising a capsular base configured with a longitudinally extending body, a conesponding cap and a series of dividing walls disposed in spaced apart relationship, both vertically and horizontally, along the length ofthe longitudinally extending body of the base, wherein the dividing walls define a plurality of independent receiving chambers having an internal periphery sufficient for introducing one or more active ingredients or medicaments having different physical states therein and for introducing a secondary capsule, having one or more active ingredients contained therein, within at least one of said receiving chambers; Figure 9 is a perspective view illustrating yet another presently prefened embodiment of a multi-compartment capsule of the present invention wherein the multi-compartment capsule shown in Figure 7 is introduced within the internal periphery of a receiving chamber of a primary capsule having one or more active ingredients also contained therein;

Figure 10 is a cross-sectional view illustrating a presently prefened embodiment of a multi-compartment capsule of the present invention including a secondary capsule having one or more active ingredients or medicaments selectively introduced into the internal periphery of a primary capsule having one or more active ingredients or medicaments, wherein the active ingredient(s) introduced into the primary capsule comprises a physical state ( e.g., solid, liquid, gas or dispersion) which differs from the physical state ofthe active ingredient(s) introduced into the internal periphery of the secondary capsule, the primary capsule further comprising a cap having a generally U-shaped configuration adapted to provide a sealing relationship when engaging the conesponding base, thereby reducing dead space volume in the internal periphery ofthe receiving chamber ofthe base; Figure 11 is a perspective view illustrating yet another presently prefened embodiment of a multi-compartment capsule of the present invention including a secondary capsule having one or more active ingredients or medicaments and having a size and shape sufficient for being selectively introduced into the internal periphery of a primary capsule having one or more active ingredients or medicaments, wherein the active ingredient(s) introduced into the primary capsule comprises a physical state ( e.g., solid, liquid, gas or dispersion) which differs from the physical state of the active ingredient(s) introduced into the internal periphery of the secondary capsule, the primary capsule further comprising a filling material introduced into the internal periphery of the cap having a general conical configuration and adapted to provide a sealing relationship when engaging the conesponding base, thereby reducing dead space volume in the internal periphery of the receiving chamber ofthe base;

Figure 12 is a cross-sectional view ofthe multi-compartment capsule shown in Figure 11 wherein a sufficient amount of filling material is introduced into the internal periphery of the cap, thereby functioning to eliminate or significantly reduce the dead space volume in the receiving chamber ofthe primary capsule; and

Figure 13 is a cross-sectional view illustrating an alternate presently prefened embodiment of a multi-compartment capsule of the present invention comprising a tertiary capsule having one or more active ingredients or medicaments and having a size a shape sufficient for being introduced into at least a portion ofthe internal periphery ofthe receiving chamber of a secondary capsule having one or more active ingredients or medicaments also introduced therein, the size and shape ofthe secondary capsule sufficient for being selectively introduced into the internal periphery of a primary capsule having one or more active ingredients or medicaments, wherein the active ingredient(s) introduced into the primary capsule comprises a physical state (e.g. , solid, liquid, gas or dispersion) which differs from the physical state of the active ingredient(s) introduced into the receiving chambers of the secondary and tertiary capsules, the primary capsule further comprising a filling material introduced into the internal periphery of the cap having a general conical configuration and adapted to provide a sealing relationship when engaging the conesponding base, thereby reducing dead space volume in the internal periphery ofthe receiving chamber of the base of the primary capsule.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

It will be readily understood that the components of the present invention, as generally described and illustrated in the Figures herein, could be ananged and designed in a wide variety of different configurations and process steps. Those of ordinary skill in the art will, of course, appreciate that various modifications to the details herein may easily be made without departing from the essential characteristics of the invention, as described. Thus, the following more detailed description of the embodiments of apparatus and methods of the present invention, as represented in Figures 1 through 13, is not intended to limit the scope of the invention, as claimed, but it is merely representative of the presently prefened embodiments ofthe invention. The presently prefened embodiments of the invention will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout.

One presently prefened embodiment of the present invention, designated generally at 10, is best illustrated in Figure 1. As shown, a multi-compartment capsule 10 is illustrated comprising a primary capsule 11 and a secondary capsule 20 selectively introduced within at least a portion of an internal periphery of the primary capsule. The secondary capsule 20 includes a base 24, a conesponding cap 22 and a receiving chamber 28 formed between the base and cap. The receiving chamber 28 is configured having an internal periphery sufficient for receiving at least one active ingredient or medicament (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) therein, h similar structural design, the primary capsule 11 may be formed having a base 14, a conesponding cap 12 and a receiving chamber 18 formed between the base and cap. The receiving chamber 18 of the primary capsule 11 is preferably formed having an internal periphery sufficient for receiving the secondary capsule 20, together with at least one active ingredient or medicament (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) therein.

Still referring to Figure 1, one presently prefened embodiment of an encapsulation process for forming a multi-compartment capsule 10 is comprising the steps of: (1) providing a primary capsule 11 having a base 14, a conesponding cap 12 and a receiving chamber 18; (2) providing a secondary capsule 20 having a base 24, a conesponding cap 22 and a receiving chamber 28; (3) introducing at least one ingredient or medicament (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) having a first physical state (e.g., solid, liquid, gas or dispersion) into at least a portion of the receiving chamber 28 of the secondary capsule 20 and selectively positioning the cap 22 in sealing relationship with the base 24; (4) introducing at least one ingredient or medicament (e.g., pharmaeceutical, biotechnical, nufraceutical, vitamin, dietary supplement, mineral or combination thereof) having a second physical state (e.g., solid, liquid, gas or dispersion) into at least a portion of the receiving chamber 18 of the primary capsule 11, wherein the first physical state of the ingredient(s) in the secondary capsule is different from the second physical state of the ingredient(s) in the primary capsule; and (5) introducing the secondary capsule 20 into at least a portion ofthe receiving chamber 18 ofthe primary capsule 11 and selectively positioning the cap 12 in sealing relationship with the base 14 to form a single dosage multi-compartment capsule. As shown, a solid is selectively introduced within at least a portion of the internal periphery ofthe receiving chamber 28 of the secondary capsule 20 and a liquid is selectively introduced within at least a portion of the internal periphery of the receiving chamber 18 of the primary capsule 11. Although the ingredient(s) introduced into the receiving chamber 18 ofthe primary capsule 11 may be the same or different from the ingredient(s) introduced into the receiving chamber 28 of the secondary capsule, the active ingredient(s) in the primary capsule 11 have a physical state (i.e., solid, liquid, gas or dispersion) that varies from the physical state of the active ingredient(s) in the secondary capsule 20. Accordingly, those skilled in the art will readily recognize other possible modifications and adaptations relative to the contemplated variations in physical states of the active ingredient(s) selectively positionable within the receiving chambers 18, 28 of the primary and secondary capsules, respectively, which are consistent with the spirit and scope of the present invention. It is intended, therefore, that the figures and examples provided herein be viewed as exemplary of the principles of the present invention, and not as restrictive to a particular structure or method for implementing those principles.

Referring now to Figure 2, an alternate presently prefened embodiment of a multi-compartment capsule 110 is shown comprising a primary capsule 111, a secondary capsule 120 and a tertiary capsule 130. The tertiary capsule 130 includes a base 134, a conesponding cap 132 and a receiving chamber 138 formed between the base and cap. The receiving chamber 138 is preferably formed having an internal periphery sufficient for receiving at least one active ingredient or medicament (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof). Structurally, the tertiary capsule 130 is configured having a size sufficient for being selectively introduced within at least a portion of an internal periphery of a receiving chamber 128 defined between a base 124 and a conesponding cap 122 of the secondary capsule 120. One or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) may be introduced into at least a portion ofthe receiving chamber 128 of the secondary capsule 120, together with the introduction of the tertiary capsule 130 comprising its active ingredient(s). The secondary capsule 120 having its active ingredient(s) and housing the tertiary capsule 130 with its active ingredient(s) may then be selectively introduced within at least a portion of an internal periphery of a receiving chamber 118 ofthe primary capsule 111 defined between a base 124 and a conesponding cap 122. Preferably, the receiving chamber 118 of the primary capsule 111 may also include one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) introduced therein. Still referring to Figure 2, another presently prefened embodiment of an encapsulation process for forming a multi-compartment capsule 110 may comprise the steps of: (1) providing a primary capsule 111 having a base 114, a conesponding cap 112 and a receiving chamber 118 defined between the base and cap; (2) providing a secondary capsule 120 having a base 124, a conesponding cap 122 and a receiving chamber 128 defined between the base and cap; (3) providing a tertiary capsule 130 having a base 134, a conesponding cap 132 and a receiving chamber 138 defined between the base and cap; (4) introducing at least one ingredient (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) having a first physical state (e.g., solid, liquid, gas or dispersion) into at least a portion of the receiving chamber 138 of the tertiary capsule 130 and selectively positioning the cap 132 in sealing relationship with the base 134; (5) introducing at least one ingredient (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) having a second physical state (e.g., solid, liquid, gas or dispersion) into at least a portion of the receiving chamber 128 of the secondary capsule 120, wherein the first physical state of the ingredient(s) in the tertiary capsule 130 are the same as the second physical state of the ingredient(s) in the secondary capsule 120; (6) introducing the tertiary capsule 130 into at least a portion of the receiving chamber 218 of the secondary capsule 120 and selectively positioning the cap 122 in sealing relationship with the base 124; (7) introducing at least one ingredient (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) having a third physical state (e.g., solid, liquid, gas or dispersion) into at least a portion of the receiving chamber 118 of the primary capsule 111, wherein the third physical state of the ingredient(s) in the primary capsule are different from the first and second physical states of the ingredient(s) in the tertiary capsule 130 and the secondary capsule 120, respectively; and (8) introducing the secondary capsule 120 into at least a portion of the receiving chamber 118 of the primary capsule 111 and selectively positioning the cap 112 in sealing relationship with the base 114 to form a single dosage multi-compartment capsule. In the presently prefened embodiment illustrated in Figure 2, a liquid may be selectively introduced into at least a portion of the internal periphery of the receiving chamber 118 ofthe primary capsule 111, a solid may be selectively introduced into at least a portion of the internal periphery of the receiving chamber 128 of the secondary capsule 120 and a solid may be selectively introduced into at least a portion of the receiving chamber 138 of the tertiary capsule 130. Although the ingredient(s) selectively introduced into the receiving chambers 118, 128, 138 of the primary, secondary and tertiary capsules 111, 120, 130, respectively, may be the same or different, the active ingredient(s) in at least two of the receiving chambers comprise at least two different physical states (e.g., solid, liquid, gas or dispersion). It is further contemplated herein as an alternate embodiment that the active ingredient(s) introduced in the receiving chamber 118 ofthe primary capsule 111 comprises a physical state (e.g., solid, liquid, gas or dispersion) different from the physical state of the active ingredient(s) contained within the receiving chamber 128 ofthe secondary capsule 120 which is different from the physical state of the active ingredient(s) contained within the receiving chamber 138 of the tertiary capsule 130. Those skilled in the art will readily recognize other possible modifications and adaptations relative to contemplated variations in physical states of the active ingredient(s) selectively introduced within the receiving chambers 118, 128, 138 of the primary, secondary and tertiary capsules, respectively, which are consistent with the spirit and scope ofthe present invention. It is intended, therefore, that the figures and examples provided herein be viewed as exemplary of the principles of the present invention, and not as restrictive to a particular structure or method for implementing those principles.

Referring now to Figures 3 and 4, another presently prefened embodiment of a multi-compartment capsule 210 is shown comprising a base 214, a conesponding cap 212 and a dividing wall 216 positionable between the base and the cap. Structurally, the size, shape and positioning ofthe dividing wall 216 relative to the base 214 and conesponding cap 212 facilitates the formation of at least two, independent and separate receiving chambers 218a, 218b, each having an internal periphery sufficient for receiving one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) therein. As best shown in Figure 4, the dividing wall 216 seats within the internal periphery of both the base 214 and the conesponding cap 212. After introducing one or more active ingredients or medicaments into receiving chamber 218b and disposing the dividing wall 216 relative thereto, one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) may be introduced into receiving chamber 218a and the cap may be selectively positioned in sealing relationship with the base 214 to form one presently prefened embodiment of the single, dosage multi-compartment capsule 210. Moreover, the dividing wall 216 may functionally assist in forming a sealing relationship between the base 214 and conesponding cap 212 of the multi-compartment capsule 210, if desired.

In one presently prefened embodiment of the multi-compartment capsule 211 of the present invention, a solid may be selectively introduced into at least a portion of the internal periphery of the receiving chamber 218a and a liquid may be selectively introduced into at least a portion of the internal periphery of the receiving chamber 218b. Although the ingredient(s) introduced into the receiving chamber 218a may be the same or different from the ingredient(s) introduced into the receiving chamber 218, the active ingredient(s) in the first receiving chamber 218a preferably comprise a physical state (e.g., solid, liquid, gas or dispersion) that is different from the physical state of the active ingredient(s) in the second receiving chamber 218b. Those skilled in the art will readily recognize other possible modifications and adaptations relative to the contemplated variations in physical states (e.g., solid, liquid, gas and dispersion) ofthe active ingredient(s) selectively positionable within the receiving chambers 218a, 218b which are consistent with the spirit and scope of the present invention. It is intended, therefore, that the figures and examples provided herein be viewed as exemplary of the principles of the present invention, and not as restrictive to a particular structure or method for implementing those principles. Referring now to Figures 5 and 6, another presently prefened embodiment of a multi-compartment capsule, designated as 310, is shown including a primary capsule 311 comprising a capsular base 314 configured having an elongated or longitudinally extending body, a conesponding cap 312 and a plurality of dividing walls 316 selectively disposed along the length of the longitudinally extending body of the base. Preferably, the structural size, shape and positioning of the dividing walls 316a, 316b, 316c along the length of the elongated body ofthe base 314 facilitate the formation of a plurality of independent receiving chambers 318a, 318b, 318c, 318d. Each receiving chamber 318a, 318b, 318c, 318d of the primary capsule 311 having an internal periphery sufficient for receiving one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) therein.

As best shown in Figure 6, the dividing walls 316a, 316b, 316c are preferably seated within the internal periphery ofthe base 314 ofthe primary capsule 311 and in a spaced apart relationship along the length ofthe longitudinally extending body and form four independent receiving chambers 318a, 318b, 318c, 318d. In one presently prefened embodiment of the multi-compartment capsule 310 of the present invention, each of the receiving chambers 318a, 318b, 318c comprises at least one active ingredient or medicament having a physical state (e.g., solid, liquid, gas or dispersion) different from the physical state of the ingredient(s) in the other receiving chambers. As illustrated by way of example, and not by way of restriction, a solid may be selectively introduced into at least a portion of the internal periphery of the receiving chamber 318a, a dispersion may be selectively introduced into at least a portion of the internal periphery ofthe receiving chamber 318b, a liquid may be selectively introduced into at least a portion of the internal periphery of the receiving chamber 318c and a secondary capsule 320 may be selectively introduced into at least a portion of the internal periphery of the receiving chamber 318d. As contemplated herein, receiving chamber 318d may be further configured having an internal periphery sufficient for receiving a secondary capsule 320, together with at least one active ingredient or medicament therein. One presently prefened embodiment of an encapsulation process, as defined by the structural configuration of the multi-compartment capsule 310 illustrated in Figures 5 and 6, may comprise the steps of: (1) introducing a secondary capsule 320 (e.g., tablet) and one or more active ingredients or medicaments into receiving chamber 318d; (2) selectively positioning dividing wall 316c along the length of the elongated body of the base 314; (3) introducing one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) into receiving chamber 318c; (4) selectively positioning dividing wall 316b along the length of the elongated body of the base 314 in a spaced apart relationship to dividing wall 316c; (5) introducing one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) into receiving chamber 318b; (6) selectively positioning dividing wall 316a along the length of the elongated body of the base 314 in a spaced apart relationship to dividing wall 316b; and (7) selectively positioning the cap 312 in sealing relationship with the base 314 to form a presently prefened embodiment of a single, dosage multi-compartment capsule 310. The dividing wall 316a may also function in the formation ofthe sealing relationship between the base 314 and the conesponding cap 312, if desired.

Although the ingredient(s) introduced into one of the receiving chambers 318 may be the same ingredient or may be different from the ingredient(s) introduced into the other receiving chambers, the active ingredient(s) in at least two of the receiving chambers 318 preferably comprise a physical state (e.g., solid, liquid, gas or dispersion) that is different from the physical state of the active ingredient(s) in one or more of the remaining receiving chambers. Those skilled in the art will readily recognize other possible modifications and adaptations relative to the contemplated variations in physical states (e.g., solid, liquid, gas and dispersion) of the active ingredient(s) selectively introduced within the receiving chambers 318 which are consistent with the spirit and scope of the present invention. It is intended, therefore, that the figures and examples provided herein be viewed as exemplary of the principles of the present invention, and not as restrictive to a particular structure or method for implementing those principles.

Another presently prefened embodiment of a multi-compartment capsule of the present invention, generally designated as 410 in Figure 7, is shown comprising a capsular base 414 preferably configured having an elongated or longitudinally extending body, a conesponding cap 412 and a plurality of dividing walls 416 selectively disposed along the length of the longitudinally extending body of the base, both horizontally and vertically. In structural design, the size, shape and positioning of the dividing walls 416a, 416b, 416c, 416d, 416e along the length ofthe longitudinally extending body ofthe base 414 facilitate the formation of a plurality of independent receiving chambers 418.

In one presently prefened embodiment, the dividing walls 416a, 416b, 416c, 416d, 416e are preferably disposed or seated in a spaced apart relationship within the internal periphery of the base 414 of the primary capsule 411 along the length of the longitudinally extending body, whereby forming five (5) independent receiving chambers 418a, 418b, 418c, 418d, 418e. Each receiving chamber 418a, 418b, 418c, 418d, 418e of the primary capsule 411 are preferably configured having an internal periphery dimensionally sufficient for receiving one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) therein.

Still referring to Figure 7, one presently prefened embodiment of an encapsulation process, as defined by the structural configuration of the multi-compartment capsule 410, may comprise the steps of: (1) introducing one or more active ingredients or medicaments into receiving chamber 418e defined by dividing walls 416d, 416e wliich are vertically disposed along the length ofthe elongated body of the base 414; (2) introducing one or more active ingredients or medicaments into receiving chamber 418d defined by dividing walls 416c, 416d which are vertically disposed along the length of the elongated body of the base 414; (3) introducing one or more active ingredients or medicaments into receiving chamber 418c defined by dividing walls 416b, 416c which are vertically disposed along the length of the elongated body of the base 414; (4) introducing one or more active ingredients or medicaments into receiving chamber 418b defined by dividing walls 416b, 416e which are vertically disposed along the length of the elongated body of the base 414; (5) disposing dividing wall 416a along the length of the elongated body of the base 414 peφendicular to the disposition of dividing walls 416b, 416c, 416d, 416e and introducing one or more active ingredients or medicaments into receiving chamber 418a; and (6) selectively positioning the cap 412 in sealing relationship with the base 414 to fonn one presently prefened embodiment of a single, dosage multi-compartment capsule 410. As appreciated, the dividing wall 416a may also function in the formation of the sealing relationship between the base 414 and the conesponding cap 412, if structurally desired. As illustrated by way of example, and not by way of restriction, a solid may be selectively introduced into at least a portion of the internal periphery of the receiving chamber 418a, a dispersion may be selectively introduced into at least a portion of the internal periphery of the receiving chamber 418b, a liquid may be selectively introduced into at least a portion of the internal periphery of the receiving chamber 418c, a solid may be selectively infroduced into at least a portion of the internal periphery of the receiving chamber 418d and a liquid may be selectively infroduced into at least a portion ofthe internal periphery ofthe receiving chamber 418e.

Although the ingredient(s) infroduced into one of the receiving chambers 418 may be the same ingredient or may be different from the ingredient(s) infroduced into the other receiving chambers, the active ingredient(s) in at least two of the receiving chambers 418 preferably comprise a physical state (e.g., solid, liquid, gas or dispersion) that is different from the physical state of the active ingredient(s) in one or more of the remaining receiving chambers. Those skilled in the art will readily recognize other possible modifications and adaptations relative to the contemplated variations in physical states (e.g., solid, liquid, gas and dispersion) of the active ingredient(s) selectively introduced within the receiving chambers 418 which are consistent with the spirit and scope of the present invention. It is intended, therefore, that the figures and examples provided herein be viewed as exemplary of the principles of the present invention, and not as restrictive to a particular structure or method for implementing those principles.

Referring now to Figure 8, an alternate presently prefened embodiment of a multi-compartment capsule 510 includes a capsular base 514 preferably configured having an elongated or longitudinally extending body, a conesponding cap 512 and a plurality of dividing walls 516 selectively disposed along the length of the longitudinally extending body of the base, both horizontally and vertically. In structural design, the size, shape and positioning of the dividing walls 516a, 516b, 516c, 516d along the length of the longitudinally extending body of the base 514 facilitate the formation of a plurality of independent receiving chambers 518.

In one presently prefened embodiment, the dividing walls 516a, 516b, 516c, 516d, 516e are preferably disposed or seated in a spaced apart relationship within the internal periphery of the base 514 of the primary capsule 511 along the length of the longitudinally extending body, whereby forming five (5) independent receiving chambers 518a, 518b, 518c, 518d, 518e. Each of the receiving chamber 518a, 518b, 518c, 518d, 518e of the primary capsule 411 are preferably configured having an internal periphery dimensionally sufficient for receiving one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) therein. Moreover, receiving chamber 518d is formed having an internal periphery sufficient for receiving a secondary capsule 520. The secondary capsule 520 being configured with a base 524, conesponding cap 522 and a dividing wall 526 defining a first receiving chamber 528a and a second receiving chamber 528b. The first receiving chamber 528a is preferably configured having an internal periphery sufficient for receiving one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) having a first physical state (e.g., solid, liquid, gas or dispersion) therein. Similarly, the second receiving chamber 528b is configured having an internal periphery sufficient for receiving one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) having a second physical state (e.g., solid, liquid, gas or dispersion), wherein the physical state of the ingredient(s) in the second receiving chamber varies from the physical state of the ingredient(s) in the first receiving chamber. As contemplated and disclosed hereinabove, after the ingredients are introduced into the respective receiving chambers 528a, 528b, the cap 522 may be positioned in sealing relationship with the base 524 ofthe secondary capsule 520.

Still referring to Figure 8, as illustrated by way of example, and not by way of restriction, a solid may be selectively introduced into at least a portion of the internal periphery of the receiving chamber 528a and a liquid may be selectively introduced into at least a portion of the internal periphery of the receiving chamber 528b. Although the ingredient(s) introduced into one of the receiving chamber 528 a may be the same ingredient or may be different from the ingredient(s) introduced into receiving chamber 528b, the active ingredient(s) in the first receiving chamber 528a comprise a physical state (e.g., solid, liquid, gas or dispersion) that is different from the physical state of the active ingredient(s) in receiving chambers 528b. Those skilled in the art will readily recognize other possible modifications and adaptations relative to the contemplated variations in physical states (e.g., solid, liquid, gas and dispersion) of the active ingredient(s) selectively infroduced within the receiving chambers 528 which are consistent with the spirit and scope of the present invention. It is intended, therefore, that the figures and examples provided herein be viewed as exemplary of the principles of the present invention, and not as restrictive to a particular structure or method for implementing those principles

One presently prefened embodiment of an encapsulation process, as defined by the structural configuration ofthe multi-compartment capsule 510, may comprise the steps of: (1) introducing one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) into receiving chamber 518e defined by dividing walls 516d, 516e which are disposed vertically along the length of the elongated body of the base 514; (2) introducing a secondary capsule 520 into receiving chamber 518d defined by dividing walls 516c, 516d which are disposed vertically along the length ofthe elongated body ofthe base 514; (3) introducing one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) into receiving chamber 518c defined by dividing walls 516b, 516c wliich are disposed vertically along the length of the elongated body of the base 514; (4) introducing one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) into receiving chamber 518b defined by dividing walls 516b, 516e which are disposed vertically along the length ofthe elongated body ofthe base 514; (5) disposing dividing wall 516a along the length of the elongated body of the base 514 peφendicular to the disposition of dividing walls 516b, 516c, 516d, 516e and introducing one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) into receiving chamber 518a; and (6) selectively positioning the cap 512 in sealing relationship with the base 514 to form one presently prefened embodiment of a single, dosage multi-compartment capsule 510. As appreciated, the dividing wall 516a may also function in the formation ofthe sealing relationship between the base 514 and the conesponding cap 512, if structurally desired.

As illustrated by way of example, and not by way of limitation, a solid may be selectively introduced into at least a portion of the internal periphery of receiving chamber 518a, a dispersion may be selectively introduced into at least a portion of the internal periphery of receiving chamber 518b, a liquid may be selectively infroduced into at least a portion of the internal periphery of the receiving chamber 518c and a liquid may be selectively introduced into at least a portion of the internal periphery of the receiving chamber 518e. Although the ingredient(s) infroduced into one ofthe receiving chambers 518 may be the same ingredient or may be different from the ingredient(s) infroduced into the other receiving chambers, the active ingredient(s) in at least two of the receiving chambers 518 preferably comprise a physical state (e.g., solid, liquid, gas or dispersion) that is different from the physical state of the active ingredient(s) in one or more of the remaining receiving chambers. Those skilled in the art will readily recognize other possible modifications and adaptations relative to the contemplated variations in physical states (e.g., solid, liquid, gas and dispersion) of the active ingredient(s) selectively introduced within the receiving chambers 518 which are consistent with the spirit and scope of the present invention. It is intended, therefore, that the figures and examples provided herein be viewed as exemplary of the principles of the present invention, and not as restrictive to a particular structure or method for implementing those principles.

Referring now to Figure 9, yet another presently prefened embodiment of a multi-compartment capsule of the present invention, generally designated as 610, is shown comprising a primary capsule 611 and a secondary capsule 620 selectively positionable within at least a portion of an internal periphery ofthe primary capsule. The primary capsule 611 having a receiving chamber 618 preferably formed having an internal periphery sufficient for receiving the secondary capsule 620, together with one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) therein. The secondary capsule 620 comprising a capsular base 624 preferably configured having an elongated or longitudinally extending body, a conesponding cap 622 and a plurality of dividing walls 626 selectively disposed along the length of the longitudinally extending body of the base, both horizontally and vertically. In structural design, the size, shape and positioning of the dividing walls 626a, 626b, 626c, 626d along the length ofthe longitudinally extending body ofthe base 624 facilitate the formation of a plurality of independent receiving chambers 628. h one presently prefened embodiment, the dividing walls 626a, 626b, 626c, 626d, 426e are preferably disposed or seated in a spaced apart relationship within the internal periphery of the base 624 of the secondary capsule 620 along the length of the longitudinally extending body, whereby forming five (5) independent receiving chambers 628a, 628b, 628c, 628d, 628e. Each receiving chamber 628a, 628b, 628c, 628d, 628e ofthe secondary capsule 620 are preferably configured having an internal periphery dimensionally sufficient for receiving one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nufraceutical, vitamin, dietary supplement, mineral or combination thereof) therein.

One presently prefened embodiment of an encapsulation process, as defined by the structural configuration ofthe multi-compartment capsule 610, may comprise the steps of: (1) introducing one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nufraceutical, vitamin, dietary supplement, mineral or combination thereof) into receiving chamber 628e defined by dividing walls 626d, 626e which are vertically disposed along the length of the elongated body of the base 624; (2) introducing one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nufraceutical, vitamin, dietary supplement, mineral or combination thereof) into receiving chamber 628d defined by dividing walls 626c, 626d which are vertically disposed along the length of the elongated body of the base 624; (3) introducing one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) into receiving chamber 628c defined by dividing walls 626b, 626c which are vertically disposed along the length of the elongated body of the base 624; (4) introducing one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) into receiving chamber 628b defined by dividing walls 626b, 626e which are vertically disposed along the length of the elongated body of the base 624; (5) disposing dividing wall 626a along the length of the elongated body of the base 624 peφendicular to the disposition of dividing walls 626b, 626c, 626d, 626e and introducing one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) into receiving chamber 628a; (6) selectively positioning the cap 622 in sealing relationship with the base 624 of the secondary capsule 620; (7) introducing the secondary capsule 620 and one or more ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) into the receiving chamber 618 of the primary capsule 611; and (8) selectively positioning the cap 612 in sealing relationship with the base 614 of the primary capsule 611 to form one presently prefened embodiment of a single, dosage multi-compartment capsule 610.

As illustrated by way of example, and not by way of restriction, a solid may be selectively introduced into at least a portion of the internal periphery of the receiving chamber 628a, a dispersion may be selectively introduced into at least a portion of the internal periphery ofthe receiving chamber 628b, a liquid may be selectively introduced into at least a portion of the internal periphery of the receiving chamber 628c, a solid may be selectively introduced into at least a portion of the internal periphery of the receiving chamber 628d and a liquid may be selectively introduced into at least a portion ofthe internal periphery of the receiving chamber 628e of the secondary capsule 620. In addition, a gas may be introduced into at least a portion of the internal periphery of the receiving chamber 618 ofthe primary capsule 611.

Although the ingredient(s) introduced into one of the receiving chambers 618, 628 of the primary and secondary capsules, respectively, may be the same ingredient or may be different from the ingredient(s) introduced into the other receiving chambers, the active ingredient(s) in at least two of the receiving chambers 618, 628 preferably comprise a physical state (e.g., solid, liquid, gas or dispersion) that is different from the physical state of the active ingredient(s) in one or more of the remaining receiving chambers. Those skilled in the art will readily recognize other possible modifications and adaptations relative to the contemplated variations in physical states (e.g., solid, liquid, gas and dispersion) ofthe active ingredient(s) selectively introduced within the receiving chambers 618, 628 which are consistent with the spirit and scope ofthe present invention. It is intended, therefore, that the figures and examples provided herein be viewed as exemplary ofthe principles ofthe present invention, and not as restrictive to a particular structure or method for implementing those principles.

Another presently prefened embodiment of a multi-compartment capsule of the present invention, generally designated as 710 in Figure 10, is shown comprising a secondary capsule 720 including one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) within at least a portion of the internal periphery of a receiving chamber 728 and having a size and shape sufficient for being selectively introduced within at least a portion of the internal periphery of a receiving chamber 718 of a primary capsule 711. The primary capsule 711 also includes one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) introduced within the internal periphery of the receiving chamber 718, wherein the active ingredient(s) introduced into the primary capsule comprises a physical state (e.g., solid, liquid, gas or dispersion) which differs from the physical state of the active ingredient(s) introduced into the internal periphery of the secondary capsule. In structural design, the primary capsule 711 further comprises a cap 712 having a generally U-shaped configuration adapted to provide a sealing relationship when engaging the conesponding base 714, thereby reducing dead space volume in the internal periphery of the receiving chamber 718 of the base. In this regard, the configuration of the cap 712 generally eliminates or substantially reduces the potential dead space volume within the internal periphery of the receiving chamber 718, thus functionally negating the opportunity for reaction between an air bubble and the active ingredient(s) introduced into the base 714 ofthe primary capsule 711.

One presently prefened embodiment of an encapsulation process, as defined by the structural configuration of the multi-compartment capsule 710, may include the steps of: (1) introducing one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nufraceutical, vitamin, dietary supplement, mineral or combination thereof) into receiving chamber 728; (2) selectively positioning the cap 722 in sealing relationship with the base 724 of the secondary capsule 720; (3) introducing one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof), together with the secondary capsule 720, into the receiving chamber 718 ofthe primary capsule 711; and (4) selectively positioning the cap 712 having a general U-shaped configuration in sealing relationship with the base 714 of the primary capsule 711 to form a presently prefened embodiment of a single, dosage multi-compartment capsule 710, wherein eliminating or substantially reducing dead space volume within the internal periphery ofthe receiving chamber 718.

A solid is selectively introduced within at least a portion of the internal periphery of the receiving chamber 728 ofthe secondary capsule 720 and a liquid is selectively introduced within at least a portion of the internal periphery of the receiving chamber 718 of the primary capsule 711. Although the ingredient(s) infroduced into the receiving chamber 718 of the primary capsule 711 may be the same or different from the ingredient(s) introduced into the receiving chamber 728 of the secondary capsule 720, the active ingredient(s) in the primary capsule have a physical state (i.e., solid, liquid, gas or dispersion) that various from the physical state ofthe active ingredient(s) in the secondary capsule. Accordingly, those skilled in the art will readily recognize other possible modifications and adaptations relative to the contemplated variations in physical states of the active ingredient(s) selectively introduced within the receiving chambers 718, 728 of the primary and secondary capsules 711, 720, respectively, which are consistent with the spirit and scope of the present invention. It is intended, therefore, that the figures and examples provided herein be viewed as exemplary of the principles of the present invention, and not as restrictive to a particular structure or method for implementing those principles.

Referring now to Figures 11 and 12, yet another presently prefened embodiment of a multi-compartment capsule 810 of the present invention is shown comprising a secondary capsule 820 including one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nufraceutical, vitamin, dietary supplement, mineral or combination thereof) within at least a portion of the internal periphery of a receiving chamber 828. The secondary capsule 820 being preferably formed having a size and shape sufficient for being selectively introduced within at least a portion of the internal periphery of a receiving chamber 818 of a primary capsule 811. Similarly, the primary capsule 811 includes one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) introduced within the internal periphery of the receiving chamber 818, together with the secondary capsule 820, wherein the active ingredient(s) introduced into the primary capsule comprises a physical state (e.g., solid, liquid, gas or dispersion) which differs from the physical state of the active ingredient(s) infroduced into the internal periphery ofthe secondary capsule 820.

In prefened structural design, the primary capsule 811 comprises a cap 812 having a general cylindrical configuration adapted to provide a sealing relationship when engaging the conesponding base 814 to form a single dosage, multi-compartment capsule 810. An amount of filling material 840 may be introduced into the internal periphery of the cap 812 to fill, either partially or completely, the inner volume of the cap, thereby reducing the dead space volume in the internal periphery ofthe receiving chamber 818 ofthe base, hi this regard, the configuration of the addition ofthe filler material 840 relative to the internal periphery ofthe cap 812 generally eliminates or substantially reduces the potential dead space volume within the internal periphery of the receiving chamber 818, thus functionally negating the potential for a reaction between an air bubble and the active ingredient(s) introduced into the base 814 of the primary capsule 811. Preferably, the filling material 840 infroduced into at least a portion of the internal periphery of the cap 812 may include a hydrophilic polymer, such as gelatin. It will be readily appreciated by those skilled in the art that other filling materials may be used, such as, for example, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, canageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl methyl cellulose, (HPMC), oleoresin, polyvinylacetate-phtalate, polymerisates of acrylic or methacrylic esters, and mixtures thereof, or the like, and/or combinations thereof. In other presently prefened embodiments of the present invention, the filling material 840 may include the introduction of an inert compound, for example, nitrogen gas into at least a portion of the internal periphery of the cap 811. Based on the principals of eliminating or reducing the volume dead space in multi-compartment capsules disclosed herein, those skilled in the art will readily recognize other possible modifications and combinations wliich are consistent with the spirit and scope of the present invention. It is intended, therefore, that the examples provided herein be viewed as exemplary of the principles of the present invention, and not as restrictive to a particular stracture or process for implementing those principles.

The filling material 840 introduced within at least a portion of the internal periphery ofthe cap 812 of the primary capsule 811 is generally intended to promote a binding contact with at least a portion of the cap 822 of the secondary capsule 820, thereby seating at least a portion ofthe secondary capsule within the cap ofthe primary capsule and forming a molded appearance. As appreciated, the introduction of the filling material 840 into the cap 812 of the primary capsule 811 prior to the joining and sealing process may prevent the opportunity for a reaction between an air bubble and the active medicament(s) within the receiving chamber 818 of the primary capsule, while preserving the overall rounded shape of the multi-compartment capsule 910 for ease of swallowing by a consumer.

As best illustrated in Figure 12, one presently prefened embodiment of an encapsulation process, as defined by the structural configuration of the multi-compartment capsule 810, may include the steps of: (1) introducing one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nufraceutical, vitamin, dietary supplement, mineral or combination thereof) into at least a portion of the receiving chamber 828; (2) selectively positioning the cap 822 in sealing relationship with the base 824 of the secondary capsule 820; (3) introducing one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof), together with the secondary capsule 820, into at least a portion of the receiving chamber 818 ofthe primary capsule 811; (4) introducing a filling material 840 into at least a portion of the internal periphery of the cap 812 (i.e., filling the cap); and (5) selectively positioning the cap 812 having a general conical configuration in sealing relationship with the base 814 of the primary capsule 811 to form one presently prefened embodiment of a single, dosage multi-compartment capsule 810, wherein eliminating or substantially reducing dead space volume within the internal periphery ofthe cap 812 and the receiving chamber 818, respectively. A solid may be selectively introduced within at least a portion of the internal periphery of the receiving chamber 828 of the secondary capsule 820 and a liquid may be selectively introduced within at least a portion of the internal periphery of the receiving chamber 818 of the primary capsule 811. Although the ingredient(s) introduced into the receiving chamber 818 of the primary capsule 811 may be the same or different from the ingredient(s) introduced into the receiving chamber 828 of the secondary capsule 820, the active ingredient(s) in the primary capsule have a physical state (i.e., solid, liquid, gas or dispersion) that various from the physical state of the active ingredient(s) in the secondary capsule. Accordingly, those skilled in the art will readily recognize other possible modifications and adaptations relative to the contemplated variations in physical states of the active ingredient(s) selectively introduced within the receiving chambers 818, 828 of the primary and secondary capsules 811, 820, respectively, Which are consistent with the spirit and scope of the present invention. It is intended, therefore, that the figures and examples provided herein be viewed as exemplary ofthe principles ofthe present invention, and not as restrictive to a particular structure or method for implementing those principles.

Referring now to Figure 13, another presently prefened embodiment of a multi-compartment capsule, generally designated at 910, is shown comprising a tertiary capsule 930 including one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) within at least a portion of the internal periphery of a receiving chamber 938 and having a size and shape sufficient for being introduced into the internal periphery of a receiving chamber 928 of a secondary capsule 920. The secondary capsule 920 having one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) infroduced within at least a portion of the internal periphery of a receiving chamber 928, together with the tertiary capsule 930. The secondary capsule 920 preferably formed having a size and shape sufficient for being selectively introduced within at least a portion of the internal periphery of a receiving chamber 918 of a primary capsule 911. Similarly, the primary capsule 911 may include one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof) introduced within the internal periphery ofthe receiving chamber 818, together with the secondary capsule 920 which houses the tertiary capsule 930. In one presently prefened embodiment, the active ingredient(s) introduced into the secondary capsule 920 comprises a physical state (e.g., solid, liquid, gas or dispersion) which differs from the physical state of the active ingredient(s) introduced into the internal periphery ofthe primary capsule 911 and the internal periphery of the tertiary capsule 930.

In preferred structural design, the primary capsule 911 comprises a cap 912 having a general cylindrical configuration adapted to provide a sealing relationship when engaging the conesponding base 914 to form a single dosage, multi-compartment capsule 910. An amount of filling material 940 may be introduced into at least a portion of the internal periphery of the cap 912 to fill, either partially or completely, the inner volume of the cap, thereby reducing the dead space volume in the cap and the internal periphery of the receiving chamber 918 of the base, h this regard, the configuration of the addition of the filler material 940 relative to the internal periphery of the cap 912 may generally eliminate or substantially reduce the potential dead space volume within the internal periphery of the receiving chamber 918, thus functionally negating the potential for a reaction between an air bubble and the active ingredient(s) introduced into the base 914 ofthe primary capsule 911. Preferably, the filling material 940 infroduced into at least a portion of the internal periphery of the cap 912 may include a hydrophilic polymer, such as gelatin. It will be readily appreciated by those skilled in the art that other filling materials may be used, such as, for example, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl methylcellulose, oleoresin, polyvinylacetate-phtalate, polymerisates of acrylic or methacrylic esters, and mixtures thereof, or the like, and/or combinations thereof. In other presently prefened embodiments of the present invention, the filling material 840 may include the introduction of an inert compound, for example, nitrogen gas into at least a portion of the internal periphery of the cap 912. Based on the principals of eliminating or reducing the volume dead space in multi-compartment capsules disclosed herein, those skilled in the art will readily recognize other possible modifications and combinations which are consistent with the spirit and scope of the present invention. It is intended, therefore, that the examples provided herein be viewed as exemplary of the principles of the present invention, and not as restrictive to a particular structure or process for implementing those principles.

The filling material 940 introduced within at least a portion of the internal periphery ofthe cap 912 of the primary capsule 911 is generally intended to promote a binding contact with at least a portion of the cap 922 of the secondary capsule 920, thereby seating at least a portion ofthe secondary capsule within the cap ofthe primary capsule and forming a molded appearance. As appreciated, the introduction of the filling material 940 into the cap 912 of the primary capsule 911 prior to the joining and sealing process tends to prevent the opportunity for a reaction between an air bubble and the active medicament(s) within the receiving chamber 918 of the primary capsule, while preserving the overall rounded shape of the multi-compartment capsule 910 for ease of swallowing by a consumer.

As best illustrated in Figure 13, one presently prefened embodiment of an encapsulation process, as defined by the structural configuration of the multi-compartment capsule 910, may include the steps of: (1) introducing one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nufraceutical, vitamin, dietary supplement, mineral or combination thereof) into at least a portion of the receiving chamber 938 of a tertiary capsule 930; (2) selectively positioning the cap 932 in sealing relationship with the base 934 of the tertiary capsule 930; (3) introducing one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof), together with the tertiary capsule 930, into at least a portion of the receiving chamber 928 of the secondary capsule 920; (4) selectively positioning the cap 922 in sealing relationship with the base 924 of the secondary capsule 920; (5) introducing one or more active ingredients or medicaments (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof), together with the secondary capsule 920, into at least a portion ofthe receiving chamber 918 ofthe primary capsule 911; (6) introducing a filling material 940 into at least a portion ofthe internal periphery of the cap 912 (i.e., preferably filling the cap); and (7) selectively positioning the cap 912 having a general conical configuration in seating relationship with at least a portion of the secondary capsule 920 and sealing the base 914 of the primary capsule 911 to form one presently prefened embodiment of a single, dosage multi-compartment capsule 910, wherein eliminating or substantially reducing dead space volume within the internal periphery ofthe cap 912 and the receiving chamber 918, respectively. A solid may be introduced within at least a portion of the internal periphery of the receiving chamber 938 of the tertiary capsule 930, a liquid may be introduced into at least a portion of the internal periphery of the secondary capsule 920 and a solid may be selectively infroduced within at least a portion of the internal periphery of the receiving chamber 918 of the primary capsule 911. Although the ingredient(s) introduced into the receiving chambers 918, 928, 938 of the primary, secondary and tertiary capsules 911, 920, 930, respectively, may be the same or different from the ingredient(s) infroduced into the other receiving chambers, the active ingredient(s) in at least two of the receiving chambers 918, 928, 938 have different physical states (i.e., solid, liquid, gas or dispersion). Those skilled in the art will readily recognize other possible modifications and adaptations relative to the contemplated variations in physical states of the active ingredient(s) selectively introduced within the receiving chambers 918, 928, 938 of the primary, secondary and tertiary capsules 911, 920, 930, respectively, which are consistent with the spirit and scope of the present invention. It is intended, therefore, that the figures and examples provided herein be viewed as exemplary of the principles of the present invention, and not as restrictive to a particular structure or method for implementing those principles.

Generally referring to Figures 1-13, the component parts of the presently prefened embodiments of the multi-compartment capsules (i.e., capsular base, conesponding cap and dividing walls) ofthe present invention may comprise a hydrophilic polymer, such as gelatin (marine or animal based product). Other suitable materials forming the capsules may include starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, canageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl methyl cellulose (HPMC), oleoresins, polyvinylacetate-phtalate, polymerisates of acrylic or methacrylic esters, and mixtures thereof, or the like, and/or combinations thereof. The material comprising the capsular components may further include between about 0% to 40% of pharmaeceutically acceptable plasticizers based upon the weight of the hydrophilic polymer. Plasticizers that may be employed include, for example and not by way of limitation, polyethylene glycol, glycerol, sorbitol, dioctyl-sodium sulfosuccinate, triethyl citrate, tributyl citrate, 1,2-propyleneglycol, mono-acetates, di-acetates, or tri-acetates of glycerol, mixtures thereof, or the like, and/or combinations thereof. As appreciated, plasticizers may also be used in the development of a soft elastic shell, often refened to as a soft gelatin capsule or "soft gel"capsule, for a primary capsule, a secondary capsule and/or a tertiary capsule. The capsular shell material may contain pharmaeceutically acceptable lubricants in the range of about 0% to 10%, based upon the weight ofthe hydrophilic polymer. Lubricants that may be used include, for example and not by way of limitation, aluminum stearate, calcium stearate, magnesium stearate, tin stearate, talc, sodium lauryl sulfate, lecithins, mineral oils, stearic acid, silicones, mixtures thereof, or the like, and/or combinations thereof. One presently prefened embodiment of the multi-compartmental capsules of the present invention (e.g., primary capsule, secondary capsule, tertiary capsule, etc.) may include, for example, LICAPS® capsules (for poorly soluble compounds), VCAPS™ capsules (made from cellulosic raw materials), CONI-SNAP® capsules and PRESS-FIT® capsules wliich are all presently manufactured by Capsugel, a subsidiary of Pfizer, Inc. In one presently prefened embodiment of an encapsulation process, the primary capsule may be kept under conditions of low humidity within a filling machine during the contemplated steps of rectifying and assembling. In certain embodiments, the primary capsule may contain moisture content in the range of approximately 0% to 6% of the total weight. Similarly, a secondary capsule, a tertiary capsule, etc. may be processed in the same manner as the primary capsule relative to conditions of low humidity during the steps of rectifying and assembling. As contemplated herein, a moisture content of approximately 0% to 3% by weight is preferable. However, capsules having a higher moisture content than those stated herein are certainly not outside the spirit and scope ofthe present invention.

As illustrated in Figures 1-9 and 11-13, the shape of the base and conesponding cap of the capsules (e.g., primary, secondary, tertiary, etc.) of the presently prefened embodiments of the multi-compartment capsules are configured having a general cylindrical shape which defines a diameter and length sufficient for the introduction of an internal smaller capsule or one or more dividing walls along the length of the capsular base. It is apparent that other geometrical configurations of the cap are likewise suitable and contemplated herein, such as the general U-shaped configuration of the cap shown in Figure 10. It is intended, therefore, that the examples provided herein be viewed as exemplary ofthe principles of the present invention, and not as restrictive to any particular structure or configuration for implementing those principles.

In one presently prefened embodiment, the clearance between the primary capsule and the secondary capsule introduced within the internal periphery of the primary capsule is preferably greater than +0.2 mm. The clearance between the outer capsular walls of the secondary capsule and the inner capsular walls ofthe primary capsule (or the tertiary capsule and the secondary capsule) may be in the range of about 0 mm to 0.5 mm, whereas the outer capsular walls of the secondary capsule or tertiary capsule may be in actual contact with the inner capsular walls of the primary capsule or secondary capsule, respectively. As appreciated, in an effort to structural facilitate independent receiving chambers on opposing sides of a dividing wall infroduced within the internal periphery of a base of a capsule, the perimeter of the dividing wall preferably engages the inner capsular walls of the capsule to provide a sealing relationship therebetween.

As further contemplated herein, the inner capsular walls of a primary capsule may be freated with an adhesive sufficient to improve engagement between the primary capsule and the outer capsular walls of a secondary capsule. A suitable technique to apply an adhesive may be by way of spraying the same on the shells and capsules immediately before assembling the same. Suitable adhesives that may be used may include, for example, tackidex, an aqueous gelatin solution, or the like. The primary, secondary or tertiary capsules, in accordance with the present invention, may be formed having the same or different colors. Moreover, the base and conesponding cap of a single capsule may be formed having different colors in an effort to enhance the aesthetics of the capsule to the consumer. In one presently prefened embodiment of a multi-compartment capsule of the present invention, the dosage may be banded, sealed or easily dividable in a contact area of the primary and secondary capsules or the sealing band may be color-coded to assist in branding, if desired.

It is further contemplated herein that a multi-compartment capsule of the present invention may comprise component parts of the capsule having various time-release coatings to facilitate the release and ultimately the absoφtion of those active ingredients infroduced into the different receiving chambers ofthe multi-compartment capsule to release at different release rates. In particular, a primary capsule may be formed having a conventional time-release coating that dissolves and releases the active ingredient(s) contained therein before the timed-release of the active ingredient(s) contained within a secondary capsule. Likewise, the dividing walls disposed within the internal periphery of the base of a capsule may be formed having conventional time-release coatings that dissolve and release the active ingredients within each receiving chamber defined by the dividing walls at different rates, thereby delivering the active ingredients or medicaments contained within a multi-compartment capsule at different rates. Certain active ingredients or medicaments may, therefore, be delivered at a selected interval, while other ingredients may be released at a later interval, hi this way, the novel design of the multi-compartment capsules of the present invention may facilitate precision delivery of active ingredients to targeted areas of the consumer. The disclosure of secondary and tertiary capsules may be replaced with other forms of microencapsulation. Microencapsulation, as previously described, refers to the process whereby minute parcels of a solid, liquid, gas or dispersion, introduced into one or more of the receiving chambers as active ingredient(s), are film-coated with a secondary material in order to shield the active ingredient from its sunounding environment. Microcapsules may measure from microns to several millimeters, whereas the main puφose being to facilitate the release ofthe active ingredients at different release rates.

The incoφoration of time-release coatings to varying the release rates of the active ingredients of a multi-compartment capsule may be used to target key time intervals or events when the body may be most able to utilize the active ingredients. In one presently prefened embodiment ofthe present invention, all ofthe active ingredients may be microencapsulated. In alternate presently prefened embodiments, only selected ingredients may be microencapsulated for delayed release, while other ingredients may be provided for immediate absoφtion. Thus, the incoφoration of time-release coatings in the encapsulation ' process when forming a multi-compartment capsule may be specifically designed to fit the needs and desires of numerous different users having similar conditions that are being targeted for treatment.

As contemplated herein, the physical states of active ingredients are characterized into one of four different states (e.g., solid, liquid, gas or dispersion). These four different states are sometimes refened to as "phases" (i.e., solid phase, liquid phase, gas phase or dispersion phase). For purposes of the present invention, the term "solid" is defined as including, by way of example only and not by way of limitation, pills, tablets, capsules (including both hard and soft elastic), powders, granulation, flakes, troches (lozenges and pastilles), suppositories and semi-solid pastes, ointments, emulsions or creams. The term "liquid" is defined as including, by way of example only and not by way of limitation, solutions, spirits, elixirs, sprays, syrups or fluid extracts. The term "dispersion" is defined as including, by way of example only and not by way of limitation, aerosols (liquid or solid in gas), suspensions (solid in liquid), emulsions (liquid in liquid), foams (gas in liquid), solid foams (solid in gas) or gels (liquid or solid in solid).

The active ingredients or medicaments introduced into the receiving chambers of the multi-compartment capsules of the present invention preferably comprise a pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof. For puφoses ofthe present invention, the term "pharmaeceutical" is defined as any substance that affects the structure or functioning of a living organism. Pharmaeceuticals, sometimes refened to as "drugs" are widely used for the prevention, diagnosis and treatment of diseases and for the relief of symptoms. The term "biotechnical" is defined as any substance that is derived from a biotechnology process. Biotechnology, sometimes shortened to "biotech", is the development of techniques and methods (e.g., genetic engineering, protein engineering, genomics, proteomics, monoclonal antibody production, polymerase chain reaction, transgenics and the like) for the application of biological processes to the production of materials of use in medicine, foods, nutrition and industry. The term "nutraceutical" is defined as any substance that is a food of a part of a food and provides medical or health benefits, including the prevention and treatment of disease. The term "vitamin" is defined as any of various organic substances or compounds that are essential for the normal processes of growth and maintenance (e.g., essential for energy transformation and regulation of metabolism) of the body which are present in natural foodstuffs or sometimes produced within the body. The term "dietary supplement" is defined as any product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for supplementing the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract or combination of any ingredient described in (A), (B), (C), (D), or (E) hereinabove. If desired, excipients may also be introduced into one or more of the receiving chambers of the multi-compartment capsules of the present invention in addition to the active ingredient(s). For example, in some cases involving medicaments with poor water solubility, it may be desirous to stabilize the liquids, solids or dispersions using a lipid, lipoid, lecithin, ghee or the like. Still further by example, in some cases involving active ingredients or medicaments with poor bioavailability, bioequivalence, or other undesirous pharmaeceutical properties (e.g., poor water solubility, pH lability, physical incompatibility, chemical incompatibility, macromolecular size and the like) such as proteins (e.g., hormones, erythropoeitms, colony stimulating factors, interferons, interleukins, plasminogen activators, monoclonal antibodies, vaccines, plant proteins, such as soy and other therapeutic proteins) or other non-polar or weak-polar materials, it may be desirous to complement the active ingredient or medicament in liquid, solid or dispersion form using a fat, lipid, lipoid, lecithin, ghee, polymers, viral and bacterial vectors and the like.

It may be demonstrated that as medical and pharmacy knowledge has continued to expand exponentially, new medicaments, new classes of medicaments and new delivery technologies are becoming available for use in animals and humans who experience particular medical diseases, illnesses or conditions. A disease, illness, or condition may affect one or more organ systems in an animal or human. Organ systems may include, for example: (1) autonomic, (2) cardiovascular, (3) neurological, (4) gastro-intestinal, (5) respiratory, (6) renal system, (7) psychiatric, (8) endocrine, (9) gynecologic, (10) urologic, (11) immunologic, (12) bone and joint systems, (13) ear, nose, and throat, (14) dermatologic, (15) hematologic, (16) infectious defense and (17) nutrition and metabolism. In an animal or human who may be suffering from one disease, illness or condition, it is common to also be suffering from a disease, illness or condition affecting one or more of the other organ system(s). These concomitant diseases, illnesses or conditions occurring within a single animal or human are often labeled as "co-morbidities," a term often shortened and referred to as "co-morbid."

New medicaments and delivery technologies are providing patients and their health care practitioners with unprecedented therapeutic options in managing diseases, illnesses and conditions. In spite of this sophistication, there has been no effort to develop new methods of using fixed combinations of medicaments for therapy of co-morbid diseases, illnesses or conditions. Moreover, there has been no effort to develop new methods of using fixed combinations of medicaments for management of a single disease, illness or condition affecting one or more organ system(s). The aforementioned fixed combinations may include a plurality of medicaments, which may be newly discovered and developed, or have been known for sometime or some combination of medicaments thereof. In any regard, said fixed combinations have not previously been contemplated in the art.

The following examples will illustrate the invention in further detail. It will be readily understood that the various active ingredients or medicaments that may be introduced into the receiving chambers of the multi-compartment capsules of the present invention, as generally described and illustrated in the Examples herein, are to be viewed as exemplary of the principles of the present invention, and not as restrictive to a particular structure or process for implementing those principles. Thus, the following more detailed description of the presently prefened embodiments of the methods, formulations, and compositions of the present invention, as represented in Examples I-XIN below, is not intended to limit the scope ofthe invention, as claimed, but is merely representative of presently prefened embodiments ofthe invention.

EXAMPLE I

[Glucosamine/Chondroitin (solid) & Vitamin E (liquid)]

As appreciated by those skilled in the art, arthritis is an inflammatory condition typically affecting the synovia membranes and cartilage of joints. It has been estimated that as many as one in three persons may experience symptoms associated with arthritis during their lifetime.

In addition to arthritis, various other chronic, debilitating conditions may afflict the aged. Many of these conditions result from the natural process of aging in humans. The natural aging process is partially due to the accumulation and effects of toxic free-radical chemicals. Free-radicals result from several homeostatic biochemical processes. It is, accordingly, desirable to develop nufraceutical or dietary supplement products which may alleviate multiple chronic, debilitating conditions. It is also desirable to package and admimster such products in the most economic and convenient possible fashion. The administration of glucosamine, a naturally occurring substance in mucopoly-saccharides, mucoproteins and chitin, is believed to promote the production of cartilage components and the repair of damaged cartilage. Clinical findings support that fibroblast cells increased production of mucopolycacchari.de and collagen synthesis when glucosamine was added. Chondroitin sulfates are large polymers of glycosaminoglycans, primarily

D-glucuronic acid and D-acetylgalactosamine, and disaccharides and may be derived from the cartilage of bovine trachea. The administration of chondroitin sulfate has been shown to promote the formation of new cartilage matrix. In particular, chondroitin stimulates the metabolism of chondrocyte cells and the production of collagen and proteoglycan. Vitamin E, also known as alpha-tocopherol, is a well-known scavenger of free-radicals in the body. Free-radical scavengers are sometimes refened to as anti-oxidants. This scavenging process is important for detoxifying the body of chemicals which are known to promote apoptosis, or programmed cell death. Apoptosis is a scientific description of cellular destruction. Although vitamin E is a popular anti-oxidant, it is poorly soluble in water and thus can be administered only as a liquid-oil formulation or in an oil formulation enclosed in a soft elastic capsule. hi one presently prefened embodiment of the present invention, therapeutically effective amounts of glucosamine, chondroitin, and vitamin E (active ingredients) may be introduced into receiving chambers of a multi-compartment capsule wherein at least two of the active ingredients have physical states (e.g., solid, liquid, gas or dispersion) that differ. Consistent with the foregoing, multi-compartment, multi-phase capsules and encapsulation technology are herein contemplated to produce a delivery vehicle for delivering anti-arthritic and anti-oxidant compounds to the body in a single dosage. A capsular format ofthe present invention may include the following composition:

Primary Capsule: Glucosamine HCI 500 mg

[500-2000 mg/day] Chondroitin sulfate 400 mg

[400-1600 mg/day ] Secondary Capsule: Vitamin E 200 IU

[200 - 400 IU/day]

The incoφoration of time-release coatings to varying the release rates of the active ingredients (e.g., glucosamine HCl/chondroitin sulfate and vitamin E) in the primary and secondary capsules, respectively, ofthe multi-compartment capsule may be used to target key time intervals or events when the body may be most able to utilize the named active ingredients. Thus, the incoφoration of time-release coatings in the encapsulation process when forming a multi-compartment capsule may be specifically designed to fit the needs and desires of numerous different users having similar conditions that are being targeted for treatment.

A therapeutically effective amount of glucosamine HCl/chondroitin sulfate may be infroduced into at least a portion of the internal periphery of the receiving chambers of a primary capsule in the form of a solid and a therapeutically effective amount of vitamin E may be introduced into at least a portion of a secondary capsule in the form of a liquid, if desired. Since the encapsulation process and multi-compartment, multi-phase capsule of the present invention are configured to apply to an anticipated treatment regime or medicinal design of a single dosage capsule, it will be readily appreciated that the introduction of one or more active ingredients into the receiving chambers of the primary and secondary capsules, respectively, is anticipated such that the various ingredients may be infroduced in different receiving chambers to accommodate different freatment modalities. For example, a multi-compartment capsule may be formulated having glucosamine HCI and chondroitin sulfate introduced into the receiving chambers of the secondary capsule and vitamin E may be introduced into the receiving chamber ofthe primary capsule. It is intended, therefore, that the examples provided herein be viewed as exemplary of the principles of the present invention, and not as restrictive to a particular structure or method for implementing those principles.

EXAMPLE II [S-adenosylmethione (SAMe) (solid) & Vitamin E (liquid)]

S-adenosylmethione (SAMe), may be derived from two materials: methionine, a sulfur-containing amino acid, and adenosine triphosphate (ATP), the body's main energy compound. SAMe was originally developed around 1950 as an antidepressant. Over the years, it has also been found that SAMe may assist in alleviating arthritic symptoms, assist in the manufacture of melatonin, which is needed to regulate sleep, help protect DNA from harmful mutations and prevent certain types of nerve damage.

As noted above, vitamin E is a popular anti-oxidant, but it is poorly soluble in water and therefore can be administered only as a liquid-oil formulation. Vitamin E is typically measured in international units (IU) of alpha tocopherol. h one presently prefened embodiment of the present invention, therapeutically effective amounts of SAMe and vitamin E (active ingredients) may be introduced into receiving chambers of a multi-compartment capsule wherein SAMe comprises a physical state (e.g., solid, liquid, gas or dispersion) different from the physical state of vitamin E. As shown in Figures 3 and 4, a therapeutically effective amount of SAMe may be infroduced into receiving chamber 218a and a therapeutically effective amount of vitamin E may be infroduced into receiving chamber 218b of a multi-compartment capsule 210 of the present invention. Consistent with the foregoing, multi-compartment, multi-phase capsules and encapsulation technology are herein contemplated to produce a delivery vehicle for delivering mood enhancing, anti-arthritic and anti-oxidant compounds to the body in a single dosage. A capsular format ofthe present invention may include the following composition:

Receiving Chamber (218a):

S-adenosylmethione 1000 mg

[200-1600 mg/day] Receiving Chamber (218b):

Vitamin E 200 IU

[200-400 IU/day]

The incoφoration of time-release coatings to varying the release rates of the active ingredients ( e.g., SAMe and vitamin E) of the multi-compartment capsule 210 may be used to target key time intervals or events when the body may be most able to utilize the named active ingredients. Thus, the incoφoration of time-release coatings in the encapsulation process when forming a multi-compartment capsule may be specifically designed to fit the needs and desires of numerous different users having similar conditions that are being targeted for treatment.

According to one presently prefened embodiment of the present invention, a therapeutically effective amoxmt of SAMe may be introduced into at least a portion of the receiving chamber 218a in the form of a solid and a therapeutically effective amount of vitamin E may be introduced into at least a portion of the receiving chamber 218b of the primary capsule 211 in the form of a liquid.

In an alternative presently prefened embodiment of the present invention, therapeutically effective amounts of SAMe and vitamin E (active ingredients) may be introduced into receiving chambers of a multi-compartment capsule wherein SAMe comprises a physical state ( e.g., solid, liquid, gas or dispersion) different from the physical state of vitamin E. As shown in Figure 2, a therapeutically effective amount of SAMe, in the fonn of a solid, may be introduced into receiving chamber 118 and 138 and a therapeutically effective amount of vitamin E, in the form of a liquid, may be infroduced into receiving chamber 128 of a multi-compartment capsule 110 of the present invention. The material forming the primary capsule shell 111 may be formulated in a manner allowing for immediate dissolution and release of the of the contents of receiving chamber 118. The material forming the secondary capsule shell 120 may be formulated in a manner allowing for either an immediate dissolution or a time-delayed dissolution and release of the contents of receiving chamber 128. The material forming the tertiary capsule shell 138 may be formulated in a manner allowing for time-delayed dissolution and release of the contents of receiving chamber 138. In this presently prefened embodiment of the present invention, a total daily dosage of SAMe may be delivered as two separate dosages within a single oral dosage form. One presently prefened embodiment of the present invention thus makes for a more convenient dosage form. <

Since the encapsulation process and multi-compartment, multi-phase capsule of the present invention are configured to apply to an anticipated freatment regime or medicinal design of a single dosage capsule, it will be readily appreciated that the introduction of one or more active ingredients into receiving chambers defined within a capsule is anticipated such that the various ingredients may be infroduced in different receiving chambers to accommodate different treatment modalities. ' It is intended, therefore, that the examples provided herein be viewed as exemplary of the principles ofthe present invention, and not as restrictive to a particular structure or method for implementing those principles.

EXAMPLE III

[Curcumin, Holy Basil, Zinc (solid) & Fish Oil

(Omega 3 Fatty Acids DHA & EPA - liquid)]

Curcumin belongs to a class of compounds derived from the turmeric root and is a yellow-orange volatile oil. It is believed that curcumin has an inhibitory effect on carcinogenesis, which is the evolution of a normal cell into a cancerous cell. There is clinical evidence to suggest curcumin may help to prevent stomach, colon, oral, esophageal, breast and skin cancers. Additional studies have been conducted to show that curcumin may be helpful in balancing cholesterol levels, protecting against ulcers by inhibition of gastric acid secretion and protection of gastric mucosal tissue, and anti-inflammatory actions. In one clinical study, curcumin was found to be as effective as non-steroidal anti-inflammatory drugs in the treatment of arthritis and post-operative pain. The administration of Holy Basil (Ocimum sanctum) has been shown to have an effect on promoting peripherally mediated analgesic effects. This action allows a broad range of therapeutic effects, including, anti-inflammatory, hypoglycemia, analgesic, anti-ulcer and anti-septic properties.

As known, zinc is a mineral that occurs in animal and plant tissues and is an important co-factor for various enzyme reactions in the body, as well as being helpful for the reproduction system, and for the manufacture of body proteins. Zinc is also an antioxidant nutrient, similar to vitamin E. There is clinical data that suggests that zinc may be important to the prostate and other reproductive organs in the body, may help in the contractility of muscles, help stabilize blood, help maintain the body's alkaline balance and aid in the digestion and metabolism of phosphorus.

Over several decades considerable evidence has been collected to suggest that fish and fish oils are beneficial to the heart, mental health and in reducing cancer risk. The "active" components of fish oils are eicosapentaenoic acid (EPA), a polyunsaturated fatty acid with a 20 carbon chain, and docosahexaenoic acid (DHA), a polyxmsaturated fatty acid with a 22 carbon chain. Both active components are members of the omega-3 group of essential fatty acids and are found exclusively in marine animals. The best sources for EPA and DHA may be fatty fish such as herring, sardines, salmon and fresh tuna.

The recommended daily intake of EPA plus DHA is between 650 to 1000 mg/day. Clinical trials have used anywhere from 1 g/day to 10 g/day, but little additional benefit has been observed at levels above 5 g/day of EPA and DHA combined. The onset of beneficial effects is variable. Effects on cholesterol may occur in just a few weeks, but it may take there (3) months or longer to see effects in degenerative diseases, such as arthritis. In one presently prefened embodiment of the present invention, therapeutically effective amounts of curcumin, Holy Basil, zinc and fish oil (active ingredients) may be introduced into receiving chambers of a multi-compartment capsule wherein curcumin, Holy Basil and zinc comprise a physical state (e.g., solid, liquid, gas or dispersion) different from the physical state of the fish oil. As shown in Figure 2, a therapeutically effective amount of curcumin may be introduced into receiving chamber 138 of a tertiary capsule 130, a therapeutically effective amount of Holy Basil and zinc may be introduced into receiving chamber 128 of a secondary capsule and a therapeutically effective amoxmt of fish oil may be introduced into receiving chamber 118 of a primary capsule 111 of a multi-compartment capsule 110 of the present invention. Consistent with the foregoing, multi-compartment, multi-phase capsules and encapsulation technology are herein contemplated to produce a delivery vehicle for delivering anti-neoplastic, anti-inflammatory, analgesic and anti-oxidant compounds to the body in a single dosage. A capsular format of the present invention may include the following composition:

Tertiary Capsule (130):

Curcumin 400 mg

[1200-1800 mg/day; 400 mg three times daily ] Secondary Capsule (120): Holy Basil 2.5 gms

[2.5 grams fresh dried leaf powder/day] Zinc 15 mg

[4 - 15 mg/day] Primary Capsule (111): Fish oil 1000 mg

(Omega 3 fatty acids - DHA & EPA) [650 - 1000 mg/day] The incoφoration of time-release coatings to varying the release rates of the active ingredients (e.g., curcumin, Holy Basil, Zinc and fish oil) in the primary, secondary and tertiary capsules 111, 120, 130 of one presently prefened embodiment of a multi-compartment capsule 110 may be used to target key time intervals or events when the body may be most able to utilize the named active ingredients. Thus, the incoφoration of time-release coatings in the encapsulation process when forming a multi-compartment capsule may be specifically designed to fit the needs and desires of numerous different users having similar conditions that are being targeted for treatment.

As contemplated herein, a therapeutically effective amoxmt of curcumin may be introduced into at least a portion of the receiving chamber 138 of the tertiary capsule 130 in the form of a solid, a therapeutically effective amoxmt of Holy Basil and zinc may be introduced into at least a portion of the receiving chamber 128 of the secondary capsule 120 in the form of a solid and a therapeutically effective amoxmt of fish oil may be introduced into at least a portion of the primary capsule 111 in the form of a liquid. Since the encapsulation process and multi-compartment, multi-phase capsule of the present invention are configured to apply to an anticipated treatment regime or medicinal design of a single dosage capsule, it will be readily appreciated that the introduction of one or more active ingredients into the receiving chambers of the primary and secondary capsules, respectively, is anticipated such that the various ingredients may be introduced in different receiving chambers to accommodate different freatment modalities. It is intended, therefore, that the examples provided herein be viewed as exemplary of the principles of the present invention, and not as restrictive to a particular structure or method for implementing those principles.

EXAMPLE IV [Vitamin C (solid) & Vitamin E (liquid)] It is believed that vitamin C plays an important role as a component of enzymes involved in the synthesis of collagen and carnitine. A vital role of vitamin C, however, is believed to be that of the primary, water-soluble antioxidant in the human body . A daily intake of 60-1000 mg of vitamin C may be adequate for preventive puφoses, but far larger quantities may be required to have an effect on halting or reversing cancer and heart disease.

As noted above, vitamin E is a popular anti-oxidant, but it is poorly soluble in water and therefore can be administered only as a liquid-oil formulation. In one presently prefened embodiment of the present invention, therapeutically effective amounts of vitamin C and vitamin E (active ingredients) may be introduced into receiving chambers of a multi-compartment capsule wherein vitamin C comprises a physical state (e.g., solid, liquid, gas or dispersion) different from the physical state of vitamin E. Consistent with the foregoing, multi-compartment, multi-phase capsules and encapsulation technology are contemplated herein to produce a delivery vehicle for delivering anti-oxidant compounds to the body in a single dosage. A capsular format of the present invention may include the following composition:

Primary Capsule: Vitamin C 500 mg

[60 - 1000 mg/day]

Secondary Capsule:

Vitamin E 200 IU

[200-400 IU/day]

The incoφoration of time-release coatings to varying the release rates of the active ingredients (e.g., vitamin C and vitamin E) in different receiving chambers of a multi-compartment capsule may be used to target key time intervals or events when the body may be most able to utilize the named active ingredients. Thus, the incoφoration of time-release coatings in the encapsulation process when forming a multi-compartment capsule may be specifically designed to fit the needs and desires of numerous different users having similar conditions that are being targeted for treatment and is contemplated herein.

A therapeutically effective amoxmt of vitamin C may be introduced into at least a portion of a first receiving chamber in the form of a solid and a therapeutically effective amount of vitamin E may be infroduced into at least a portion of a second receiving chamber in the form of a liquid. Since the encapsulation process and multi-compartment, multi-phase capsule ofthe present invention are configured to apply to an anticipated treatment regime or medicinal design of a single dosage capsule, it will be readily appreciated that the introduction of one or more active ingredients into the receiving chambers ofthe primary and secondary capsules, respectively, is anticipated such that the various ingredients may be introduced in different receiving chambers to accommodate different treatment modalities. It is intended, therefore, that the examples provided herein be viewed as exemplary of the principles of the present invention, and not as restrictive to a particular structure or method for implementing those principles.

EXAMPLE V [Selenium/Vitamin C (solid) & Vitamin E,/Beta-Carotene/ Fish Oil (Omega 3 Fatty Acids DHA & EPA) (liquid)] Selenium is an essential trace mineral in the human body and an important part of antioxidant enzymes that protect cells against the effects of free radicals that are produced during normal oxygen metabolism. As readily known in the art, the body has developed defenses, such as antioxidants, to assist in controlling levels of free radicals which can cause damage to cells and contribute to the development of some chronic diseases. It is also believed that Selenium is essential for normal functioning ofthe immune system and thyroid gland. The recommended dietary allowance for selenium is 55 meg/day.

As noted above, it is believed that vitamin C plays an important role as a component of enzymes involved in the synthesis of collagen and carnitine and a vital role as a water- soluble antioxidant in the human body. Vitamin E is another important anti-oxidant.

Beta-carotene is a substance foxind in plants that the body converts into vitamin A. It is believed that beta-carotene acts as an antioxidant and an immune system booster. There is no RDA for beta-carotene. The most common beta-carotene supplement intake is about 25,000 IU (15 mg) per day, however supplementation with as much as 100,000 IU (60 mg) per day has been reported. It has been suggested that fish and fish oils are beneficial to the heart, mental health and in reducing cancer risk. The recommended daily intake of EPA plus DHA (the active components of fish oil) is between 650 to 1000 mg/day. Clinical trials have used anywhere from 1 g/day to 10 g/day, but little additional benefit has been observed at levels above 5 g/day of EPA and DHA combined. h one presently prefened embodiment of the present invention, therapeutically effective amounts of selenium, vitamin C, beta-carotene, vitamin E and fish oil (active ingredients) may be introduced into receiving chambers of a multi-compartment capsule wherein selenium and vitamin C comprise a physical state (e.g., solid, liquid, gas or dispersion) different from the physical state of vitamin E, beta-carotene and fish oil (omega 3 fatty acids DHA & EPA). Specifically, a therapeutically effective amoxmt of selenium and vitamin C may be infroduced into one or more receiving chambers of a primary capsule and a therapeutically effective amount of vitamin E, beta-carotene and fish oil (omega 3 fatty acids DHA & EPA) may be infroduced into one or more receiving chambers of a secondary capsule to form a multi-compartment capsule ofthe present invention. Consistent with the foregoing, multi-compartment, multi-phase capsules and encapsulation technology are herein contemplated to produce a delivery vehicle for delivering anti-oxidant compounds to the body in a single dosage. A capsular format ofthe present invention may include the following composition:

Primary Capsule:

Selenium 50 meg

[50 - 100 meg/day]

Vitamin C 500 mg [60-1000 mg/day ]

Secondary Capsule:

Beta-carotene 50 mg

[30 - 300 mg/day] Vitamin E 200 IU

[200-400 IU/day] Fish oil 1000 mg

(Omega 3 fatty acids - DHA & EPA) [650 - 1000 mg/day]

The incoφoration of time-release coatings to varying the release rates of the active ingredients (e.g., selenium, vitamin C , vitamin E, beta carotene and fish oil) in different receiving chambers of a multi-compartment capsule may be used to target key time intervals or events when the body may be most able to utilize the named active ingredients. Thus, the incoφoration of time-release coatings in the encapsulation process when forming a multi-compartment capsule may be specifically designed to fit the needs and desires of numerous different users having similar conditions that are being targeted for treatment and is contemplated herein. A therapeutically effective amoxmt of selenium and vitamin C may be introduced into one or more receiving chambers of a primary capsule in solid form and a therapeutically effective amoxmt of vitamin E, beta carotene and fish oil may be introduced into one or more receiving chambers of a secondary capsule in the form of a liquid. Since the encapsulation process and multi-compartment, multi-phase capsule of the present invention are configured to apply to an anticipated treatment regime or medicinal design of a single dosage capsule, it will be readily appreciated that the introduction of one or more active ingredients into the receiving chambers of the primary and secondary capsules, respectively, is anticipated such that the various ingredients may be infroduced in different receiving chambers to accommodate different treatment modalities. It is intended, therefore, that the examples provided herein be viewed as exemplary of the principles of the present invention, and not as restrictive to a particular structure or method for implementing those principles.

EXAMPLE VI [Fluoxetine (solid), S-adenosylmethione (SAMe) (solid) & Vitamin E (liquid)] As appreciated by those skilled in the art, depression is a mental state characterized by excessive sadness. Depression is one of several forms of mood disorders. Activity in those affected with depression may be agitated and restless or slow and retarded. Those affected may also show pessimistic or despairing behavior and may have disturbances in sleep, appetite and concentration. Depression is often a co-morbid condition with other chronic disease states involving the neurological system, cardiovascular system, respiratory system, endocrine system, musculoskeletal system, immune system, genitourinary system and the like. This list is should not be considered exclusive.

Administration of Fluoxetine is known by those of skill in the art to alleviate the signs and symptoms of depression. Fluoxetine belongs to a class of compounds which are given the functional name: selective serotonin re-uptake inhibitors (SSRI's). This class may include, for example: fluoxetine (PROZAC®), sertraline (ZOLOFT®), paroxetine (PAXIL ®), fluvoxamine (LUVOX®), citalopram (CELEXA®) and escitalopram (LEXAPRO®). As appreciated, the foregoing list is provided herein as exemplary and should not be considered exclusive or exhaustive.

Fluoxetine is a bicyclic compound, similar in structure to phenylpropanolamine. Fluoxetine structure imparts a high selectivity for interaction with cells ofthe nervous system for the function of preventing the re-uptake of serotonin into pre-synaptic cell storage sites. This action leads to marked increases in synaptic concentration of serotonin and is facilitative of numerous physiological processes requiring serotonin neurotransmission. In the pharmaeceutical field Fluoxetine is available as a hydrochloride salt (HCI). S-adenosylmethione (SAMe), is derived from two materials: methionine, a sulfttr-containing amino acid, and adenosine triphosphate (ATP), the body's main energy compound. SAMe was originally developed around 1950 as an antidepressant, but it was also found to be helpful in the alleviation of arthritic symptoms. SAMe is essential for the manufacture of melatonin, which is needed to regulate sleep. It also helps to protect DNA from harmful mutations and may help prevent certain types of nerve damage. Cunent clinical research is beginning to confirm these antidepressant qualities of SAMe.

Vitamin E, also named alpha-tocopherol, is a well-known scavenger of free-radicals in the body. Free-radical scavengers are sometimes refened to as anti-oxidants. This scavenging process is important for detoxifying the body of chemicals which are known to promote apoptosis, or programmed cell death. Apoptosis is a scientific description of cellular destruction. Although it is a popular anti-oxidant, Vitamin E is poorly soluble in water and thus can be admimstered only as a liquid-oil formulation or in an oil formulation enclosed in a soft elastic capsule. Vitamin E is typically measured in international units (IU) of alpha tocopherol.

In one presently prefened embodiment of the present invention, therapeutically effective amounts of Fluoxetine, SAMe and Vitamin E (active ingredients) may be infroduced into receiving chambers of a multi-compartment capsule wherein Fluoxetine and SAMe comprises a physical state (e.g., solid, liquid, gas or dispersion) different from the physical state of Vitamin E. As shown in Figures 3 and 4, a therapeutically effective amoxmt of Fluoxetine and SAMe may be introduced into receiving chamber 218a and a therapeutically effective amount of Vitamin E may be introduced into receiving chamber 218b of a multi-compartment capsule 210 of the present invention. Consistent with the foregoing, multi-compartment, multi-phase capsules and encapsulation technology are herein contemplated to produce a delivery vehicle for delivering mood enhancing, anti-depressant and anti-oxidant compounds to the body in a single dosage. A capsular format of the present invention may include the following composition:

Receiving Chamber (218a):

Fluoxetine 20 mg

[20 - 60 mg/day] S-adenosylmethione 1000 mg

[200-1600 mg/day] Receiving Chamber (218b):

Vitamin E 200 IU

[200-400 IU/day] The incoφoration of time-release coatings to varying the release rates of the active ingredients (e.g., Fluoxetine/SAMe and Vitamin E) in the primary and secondary capsules, respectively, of the multi-compartment capsule may be used to target key time intervals or events when the body may be most able to utilize the named active ingredients. Thus, the incoφoration of time-release coatings in the encapsulation process when forming a multi-compartment capsule may be specifically designed to fit the needs and desires of numerous different users having similar conditions that are being targeted for treatment.

According to one presently prefened embodiment of the present invention, a therapeutically effective amount of Fluoxetine and SAMe may be infroduced into at least a portion of the receiving chamber 218a in the form of a solid and a therapeutically effective amoxmt of Vitamin E may be introduced into at least a portion ofthe receiving chamber 218b ofthe primary capsule 211 in the form of a liquid.

In an alternative presently prefened embodiment of the present invention, therapeutically effective amounts of Fluoxetine and SAMe and Vitamin E (active ingredients) may be introduced into receiving chambers of a multi-compartment capsule wherein Fluoxetine and SAMe comprises a physical state (e.g., solid, liquid, gas or dispersion) different from the physical state of Vitamin E. As shown in Figure 2, a therapeutically effective amount of Fluoxetine and SAMe, in the form of a solid, may be introduced into receiving chamber 118 and 138 and a therapeutically effective amoxmt of Vitamin E, in the form of a liquid, may be introduced into receiving chamber 128 of a multi-compartment capsule 110 of the present invention. The material forming the primary capsule shell 111 may be formulated in a manner allowing for immediate dissolution and release of the of the contents of receiving chamber 118. The material forming the secondary capsule shell 120 may be formulated in a manner allowing for either an immediate dissolution or a time-delayed dissolution and release of the contents of receiving chamber 128. The material forming the tertiary capsule shell 138 may be fonnulated in a manner allowing for time-delayed dissolution and release of the contents of receiving chamber 138. hi this presently prefened embodiment of the present invention, a total daily dosage of Fluoxetine and SAMe may be delivered as two separate dosages within a single oral dosage form. One presently prefened embodiment of the present invention thus makes for a more convenient dosage form. Since the encapsulation process and multi-compartment, multi-phase capsule of the present invention are configured to apply to an anticipated freatment regime or medicinal design of a single dosage capsule, it will be readily appreciated that the introduction of one or more active ingredients into the receiving chambers of the primary and secondary capsules, respectively, is anticipated such that the various ingredients may be introduced in different receiving chambers to accommodate different treatment modalities. For example, a multi-compartment capsule may be formulated having Fluoxetine and SAMe infroduced into the receiving chambers of the secondary capsule and Vitamin E may be infroduced into the receiving chamber of the primary capsule. It is intended, therefore, that the examples provided herein be viewed as exemplary ofthe principles ofthe present invention, and not as restrictive to a particular structure or method for implementing those principles.

EXAMPLE Nil [Rofecoxib (solid) & Vitamin E (liquid)] As appreciated by those skilled in the art, arthritis is an inflammatory condition typically affecting the synovia and cartilage of joints. It has been estimated that as many as one in three persons may experience symptoms associated with arthritis during their lifetime.

In addition to arthritis, various other chronic, debilitating conditions may afflict the aged. Many of these conditions result from the natural process of aging in humans. The natural aging process is partially due to the accumulation and effects of toxic free-radical chemicals. Free-radicals result from several homeostatic biochemical processes. It is, accordingly, desirable to develop pharmaeceutical, biotechnical, nufraceutical or dietary supplement products which may alleviate multiple chronic, debilitating conditions. It is also desirable to package and administer such products in the most economic and convenient possible fashion. Anti-inflammatory agents may have many diverse therapeutic roles in the human body. Inflammation is the process undertaken by the body as it responds to an injury. A typical inflammatory response involves blood vessel dilation, increased blood flow to the site of injury, and influx of white blood cells to process and remove dead tissue. Inflammation can lead to pain and swelling at the site of injury. Medicaments used in modulating the inflammatory response may be divided into steroid and non-steroidal labels. The latter is more commonly identified as non-steroidal anti-inflammatory drugs (NSAIDs).

Rofecoxib belongs to a class of NSAID compounds given the functional name cyclo-oxygenase-2 ("COX-2") inhibitors. This class may include, for example: rofecoxib (VIOXX®), celecoxib (CELEBREX®), valdecoxib (BEXTRA®), and meloxicam (MOBIC®). As appreciated, the foregoing list is provided herein as exemplary and should not be considered exclusive or exhaustive.

Rofecoxib is presently believed to inhibit the action of COX-2, an enzyme involved in the production of prostaglandins in the human body. Prostaglandins serve many diverse roles, one of which is to stimulate an inflammation mechanism in immxme responses. Recently, Rofecoxib was labeled for use in the treatment of osteoarthritis, rheumatoid arthritis, acute pain, and primary dysmenonhea.

Vitamin E, also named alpha-tocopherol, is a well-known scavenger of free-radicals in the body. Free-radical scavengers are sometimes refened to as anti-oxidants. This scavenging process is important for detoxifying the body of chemicals which are known to promote apoptosis, or programmed cell death. Apoptosis is a scientific description of cellular destruction. Although it is a popular anti-oxidant, Vitamin E is poorly soluble in water and thus can be administered only as a liquid-oil formulation or in an oil formulation enclosed in a soft elastic capsule. h one presently prefened embodiment of the present invention, therapeutically effective amounts of Rofecoxib and Vitamin E (active ingredients) may be introduced into receiving chambers of a multi-compartment capsule wherein Rofecoxib comprises a physical state (e.g., solid, liquid, gas or dispersion) different from the physical state of Vitamin E. As shown in Figures 3 and 4, a therapeutically effective amoxmt of Rofecoxib maybe introduced into receiving chamber 218a and a therapeutically effective amoxmt of Vitamin E may be infroduced into receiving chamber 218b of a multi-compartment capsule 210 of the present invention. Consistent with the foregoing, multi-compartment, multi-phase capsules and encapsulation technology are herein contemplated to produce a delivery vehicle for delivering anti-inflammatory and anti-oxidant compounds to the body in a single dosage. A capsular format ofthe present invention may include the following composition:

Receiving Chamber (218a): Rofecoxib 25 mg

[12.5 - 25 mg/day] Receiving Chamber (218b):

Vitamin E 200 IU

[200-400 IU/day]

The incoφoration of time-release coatings to varying the release rates of the active ingredients (e.g., Rofecoxib and Vitamin E) of the multi-compartment capsule 210 may be used to target key time intervals or events when the body may be most able to utilize the named active ingredients. Thus, the incoφoration of time-release coatings in the encapsulation process when forming a multi-compartment capsule may be specifically designed to fit the needs and desires of numerous different users having similar conditions that are being targeted for treatment.

According to one presently prefened embodiment of the present invention, a therapeutically effective amount of Rofecoxib may be introduced into at least a portion ofthe receiving chamber 218a in the form of a solid and a therapeutically effective amoxmt of

Vitamin E may be introduced into at least a portion of the receiving chamber 218b of the primary capsule 211 in the form of a liquid. In an alternative presently prefened embodiment of the present invention, therapeutically effective amounts of Rofecoxib and Vitamin E (active ingredients) may be introduced into receiving chambers of a multi-compartment capsule wherein Rofecoxib comprises a physical state (e.g., solid, liquid, gas or dispersion) different from the physical state of Vitamin E. As shown in Figure 2, a therapeutically effective amoxmt of Rofecoxib, in the form of a solid, may be introduced into receiving chamber 118 and 138 and a therapeutically effective amount of Vitamin E, in the form of a liquid, may be infroduced into receiving chamber 128 of a multi-compartment capsule 110 of the present invention. The material forming the primary capsule shell 111 may be formulated in a manner allowing for immediate dissolution and release of the of the contents of receiving chamber 118. The material foraiing the secondary capsule shell 120 may be formulated in a manner allowing for either an immediate dissolution or a time-delayed dissolution and release of the contents of receiving chamber 128. The material forming the tertiary capsule shell 138 may be formulated in a manner allowing for time-delayed dissolution and release of the contents of receiving chamber 138. In this presently prefened embodiment of the present invention, a total daily dosage of Rofecoxib maybe delivered as two separate dosages within a single oral dosage form. One presently prefened embodiment of the present invention thus makes for a more convenient dosage form.

Since the encapsulation process and multi-compartment, multi-phase capsule of the present invention are configured to apply to an anticipated treatment regime or medicinal design of a single dosage capsule, it will be readily appreciated that the introduction of one or more active ingredients into receiving chambers defined within a capsule is anticipated such that the various ingredients may be infroduced in different receiving chambers to accommodate different treatment modalities. It is intended, therefore, that the examples provided herein be viewed as exemplary ofthe principles ofthe present invention, and not as restrictive to a particular structure or method for implementing those principles. EXAMPLE Vπi

[Diphenhydramine Hydrochloride (solid) & Vitamin E (liquid)]

As appreciated by those skilled in the art, allergic reactions are conditions wherein the immune system is stimulated to identify, segregate and dispose of exogenous chemicals which cannot be recognized by the body. Allergic reactions are often associated with the release of histamine, a chemical compound which produces changes in the permeability of blood vessels and the accumulation of other immune system cells. In some circumstances, it may be desirable to modulate the amount of allergic response that is capable of being generated by the immxme system. Diphenhydramine belongs to a class of compounds which are given the functional name: histamine- 1 (R ) receptor antagonists. These compounds are more generally labeled as antihistamines. These antagonists are further divided according to their chemical structures. Diphenhydramine is an ethanolamine (aminoalkyl ether) derivative. Other chemical divisions may include, for example: ethylenediamine, propylamine, phenothiazine, piperazine. The ethanolamine division may include, for example: diphenhydramine, clemastine, dimenhydrinate, and doxylamine. As appreciated, the foregoing list is provided herein as exemplary and should not be considered exclusive or exhaustive.

Antihistamines block the interaction of the neurotransmitter, histamine, with R receptors located in smooth muscle linings of the gastrointestinal tract, bronchial tract and large blood vessels. This blocking action may lead to marked relaxation in smooth muscle tone and is facilitative of numerous physiological processes including respiration.

The R antagonists may also be divided according to their selectivity for central and peripheral R receptors. A second-generation of R\ has emerged in recent years. These agents have a greater selectivity for peripheral Hj receptors. Second-generation R receptor antagonists may include, for example: azelastine (ASTELIN®), cetirizine (ZYRTEC®), desloratadine (CLARINEX®), fexofenadine (ALLEGRA®) and loratadine (CLARITDSfn®).

Vitamin E, also named alpha-tocopherol, is a well-known scavenger of free-radicals in the body. Free-radical scavengers are sometimes refened to as anti-oxidants. This scavenging process is important for detoxifying the body of chemicals which are known to promote apoptosis, or programmed cell death. Apoptosis is a scientific description of cellular destruction. Although it is a popular anti-oxidant, Vitamin E is poorly soluble in water and thus can be administered only as a liquid-oil formulation or in an oil formulation enclosed in a soft elastic capsule.

In one presently prefened embodiment of the present invention, therapeutically effective amounts of Diphenhydramine and Vitamin E (active ingredients) maybe infroduced into receiving chambers of a multi-compartment capsule wherein at least two of the active ingredients have physical states (e.g., solid, liquid, gas or dispersion) that differ. Consistent with the foregoing, multi-compartment, multi-phase capsules and encapsulation technology are herein contemplated to produce a delivery vehicle for delivering anti-allergic and anti-oxidant compounds to the body in a single dosage. A capsular format of the present invention may include the following composition:

Primary Capsule:

Diphenhydramine HCI 50 mg

[25 - 100 mg/day] Secondary Capsule:

Vitamin E 200 IU [200-400 IU/day]

The incoφoration of time-release coatings to varying the release rates of the active ingredients ( e.g., Diphenhydramine and Vitamin E) in the primary and secondary capsules, respectively, of the multi-compartment capsule may be used to target key time intervals or events when the body may be most able to utilize the named active ingredients. Thus, the incoφoration of time-release coatings in the encapsulation process when forming a multi-compartment capsule may be specifically designed to fit the needs and desires of numerous different users having similar conditions that are being targeted for treatment. A therapeutically effective amoxmt of Diphenhydramine may be introduced into at least a portion of the internal periphery ofthe receiving chambers of a primary capsule in the form of a solid and a therapeutically effective amoxmt of Vitamin E may be introduced into at least a portion of a secondary capsule in the form of a liquid, if desired. Since the encapsulation process and multi-compartment, multi-phase capsule of the present invention are configured to apply to an anticipated treatment regime or medicinal design of a single dosage capsule, it will be readily appreciated that the introduction of one or more active ingredients into the receiving chambers of the primary and secondary capsules, respectively, is anticipated such that the various ingredients may be introduced in different receiving chambers to accommodate different treatment modalities. For example, a multi-compartment capsule may be formulated having Diphenhydramine infroduced into the receiving chambers ofthe secondary capsule and Vitamin E may be infroduced into the receiving chamber of the primary capsule. It is intended, therefore, that the examples provided herein be viewed as exemplary of the principles of the present invention, and not as restrictive to a particular structure or method for implementing those principles.

EXAMPLE IX [Celecoxib (solid) & Ibuprofen (liquid)] As appreciated by those skilled in the art, arthritis is an inflammatory condition typically affecting the synovia and cartilage of joints. It has been estimated that as many as one in three persons may experience symptoms associated with arthritis during their lifetime. Anti-inflammatory agents may have many diverse therapeutic roles in the human body. Inflammation is the process undertaken by the body as it responds to an injury. A typical inflammatory response involves blood vessel dilation, increased blood flow to the site of injury, and influx of white blood cells to process and remove dead tissue. Inflammation can lead to pain and swelling at the site of injury. Medicaments used in modulating the inflammatory response may be divided into steroid and non-steroidal labels. The latter is more commonly identified as non-steroidal anti-inflammatory drugs (NSAIDs). Celecoxib belongs to a class of NSAID compounds given the functional name cyclo-oxygenase-2 ("COX-2") inhibitors. This class may include, for example: rofecoxib

(VIOXX®), celecoxib (CELEBREX®), valdecoxib (BEXTRA®), etodolac (LODINE®) and meloxicam (MOBIC®). As appreciated, the foregoing list is provided herein as exemplary and should not be considered exclusive or exhaustive.

Celecoxib is believed to inhibit the action of COX-2, an enzyme involved in the production of prostaglandins in the human body. Prostaglandins serve many diverse roles, one of which is to stimulate an inflammation mechanism in immxme responses. Recently, Celecoxib was labeled by the United States Food and Drug Administration (FDA) for use in the freatment of osteoarthritis, rheumatoid arthritis, acute pain, and primary dysmenonhea.

Ibuprofen is another NSAID and is believed to function as a non-selective inhibitor of cyclo-oxygenase. Ibuprofen has been labeled by the FDA for use in the treatment of osteoarthritis, rheumatoid arthritis, relief of mild to moderate pain and primary dysmenonhea. Ibuprofen belongs to a class of compounds called phenyl-a-methylacetic acids, which are derived from salicylic acid. Non-selective cyclo-oxygenase inhibitors may include, for example: ibuprofen (MOTRIN®), naproxen (NAPROSYN®), diclofenac (VOLTAREN®), flurbiprofen (ANSAID®), indomethacin (INDOCIN®), ketoprofen (ORUDIS®), ketorolac (TORADOL®), nabumetone (RELAFEN®), oxaprozin (DAYPRO®), piroxicam (FELDENE ®) and sulindac (CLINORIL®). As appreciated, the foregoing list is provided herein as exemplary and should not be considered exclusive or exhaustive.

In one presently preferred embodiment of the present invention, therapeutically effective amounts of Celecoxib and Ibuprofen (active ingredients) may be infroduced into receiving chambers of a multi-compartment capsule wherein Celecoxib comprises a physical state (e.g., solid, liquid, gas or dispersion) different from the physical state of Ibuprofen. As shown in Figures 3 and 4, a therapeutically effective amoxmt of Celecoxib may be introduced into receiving chamber 218a and a therapeutically effective amount of ibuprofen may be introduced into receiving chamber 218b of a multi-compartment capsule 210 of the present invention. Consistent with the foregoing, multi-compartment, multi-phase capsules and encapsulation technology are herein contemplated to produce a delivery vehicle for delivering anti-arthritic and anti-oxidant compounds to the body in a single dosage. A capsular format ofthe present invention may include the following composition:

Receiving Chamber (218a):

Celecoxib 200 mg

[200 - 400 mg/day] Receiving Chamber (218b): Ibuprofen 800 mg

[2400 - 3200 mg/day]

The incoφoration of time-release coatings to varying the release rates of the active ingredients (e.g., Celecoxib and Ibuprofen) of the multi-compartment capsule 210 may be used to target key time intervals or events when the body may be most able to utilize the named active ingredients. Thus, the incoφoration of time-release coatings in the encapsulation process when forming a multi-compartment capsule may be specifically designed to fit the needs and desires of numerous different users having similar conditions that are being targeted for treatment. According to one presently prefened embodiment of the present invention, a therapeutically effective amount of Celecoxib may be introduced into at least a portion ofthe receiving chamber 218a in the form of a solid and a therapeutically effective amount of Ibuprofen may be introduced into at least a portion of the receiving chamber 218b of the primary capsule 211 in the form of a liquid. In an alternative presently prefened embodiment of the present invention, therapeutically effective amounts of Celecoxib and Ibuprofen (active ingredients) may be introduced into receiving chambers of a multi-compartment capsule wherein Celecoxib comprises a physical state (e.g., solid, liquid, gas or dispersion) different from the physical state of Ibuprofen. As shown in Figure 2, a therapeutically effective amoxmt of Celecoxib, in the form of a solid, may be infroduced into receiving chamber 128 and a therapeutically effective amount of ibuprofen, in the form of a liquid, may be introduced into receiving chambers 118 and 138 of a multi-compartment capsule 110 ofthe present invention. The material forming the primary capsule shell 111 may be formulated in a manner allowing for immediate dissolution and release of the of the contents of receiving chamber 118. The material forming the secondary capsule shell 120 may be formulated in a manner allowing for either an immediate dissolution or a time-delayed dissolution and release of the contents of receiving chamber 128. The material forming the tertiary capsule shell 138 may be formulated in a manner allowing for time-delayed dissolution and release of the contents of receiving chamber 138. In this presently prefened embodiment ofthe present invention, a total daily dosage of ibuprofen may be delivered as two separate dosages within a single oral dosage form. One presently prefened embodiment of the present invention thus makes for a more convenient dosage form. Since the encapsulation process and multi-compartment, multi-phase capsule of the present invention are configured to apply to an anticipated treatment regime or medicinal design of a single dosage capsule, it will be readily appreciated that the introduction of one or more active ingredients into receiving chambers defined within a capsule is anticipated such that the various ingredients may be infroduced in different receiving chambers to accommodate different treatment modalities. It is intended, therefore, that the examples provided herein be viewed as exemplary ofthe principles of the present invention, and not as restrictive to a particular structure or method for implementing those principles.

EXAMPLES X Some embodiments of the present invention will use one or more of the below ingredients in a multi-compartment capsule, combinable as would be recognized in view of the teachings of the present application in combination with the knowledge available to one of ordinary skill in the art. It is noted that the following non-limiting lists illustrate exemplary ingredeints that can be used with the present invention, including the the broader subclasses and classes to which they belong.

Botanicals

Acerola Extracts Alfalfa

Algae, Blue Green Aloe

Amla Angelica Root

Bacopa Monnieri Mucuna Pruriens

Anise Seed Arnica

Artichoke Ashwagandha

Astragalus Ayurvedic Herbs

Barbeny Barley Grass

Barley Sprout Extract Benzoin

Bilbeny Bioflavonoids

Bitter Melon Bitter Orange

Black Cohosh Black Cunant

Black Walnut Bladderwrack

Blue Cohosh Bluebeny

Boswellia Brahmi

Broccoli Burdock

Butcher's Broom Calendula

Capsicum Cascara Sagrada

Cat's Claw Cayenne

Celery Seed Certified Organic Herbs

Chamomile Chapparal

Chaste Beny Chicory Root

Chinese Herbs Chlorella

Chlorophyll Citrus Aurantium

Cocoa Coriander

Corn Silk Cranbeny

Curcuminoids Damiana

Dandelion Devil's Claw

Diosgenin Dong Quai

Echinacea Elderbeny

Elecampane Root Ephedra

Essential Oils Eucalyptus

Evening Primrose Eyebright

Fennel Fenugreek

Feverfew Flax Products

Fo Ti Garcinia Cambogia

Garlic Gentian

Ginger Ginkgo Biloba

Ginseng (American) Ginseng (Panax)

Ginseng (Siberian) Goldenseal

Gotu Kola Grape Seed Extract

Grape Skin Extract Grapefruit Seed Extract

Green Food Products Green Lipped Mussel Powder Green Tea Griffonia Simplicifolia

Guarana Guggul

Gymnema Sylvestre Hawthorne

Herma Herbal Exfracts, Standardized

Herbal Teas Hops

Horehound Horse Chestnut

Horsetail Hysop

Ipriflavone Jojoba Oil

Juniper Berries Kava Kava

Kelp Extract Kola Nut

Kombucha Kudzu

Larch Lavender

Lemon Balm Licorice Extract

Linden Flowers Lobelia

Maca Maitake Mushroom

Marshmallow Milk Thistle

Molasses Mushrooms

Neem Nettle

Noni Nopal

Oatstraw Octacosanol

Olive Extract Orange Peel Extract

Oregano Oil Oregon Mountain Grape

Organic Sweeteners Parsley

Passion Flower Pau d'Arco

Pennyroyal Peppermint

Pfaffia Paniculata Pine Bark Extract

Piper Longum Pygeum Africanum

Quercitin Raspbeny Powder

Red Clover Red Raspberry

Reishi Mushroom Resveratrol Extract

Rhubarb Root Rice Products

Rose Hips Rosemary Extract

Sage Sarsaparilla

Saw Palmetto Schizandra

Seaweed extracts Senna

Shatavari Shiitake Mushroom

Silymarin Skullcap

Slippery Elm Soy Isoflavones

Soybean Products Spirulina

St. John's Wort Stevia

Summa Tea Tree Oil

Terminalia Ajruna Tribulus Tenestris

Triphala Tumeric

Uva Ursi Valerian Extract

Vegetable Extracts Vitex

Wheat Germ White Willow Bark

Wild Cherry bark Wild Yam

Witch Hazel Wormwood

Yarrow Yellow Dock

Yerba Sante Yohimbine Yucca

Extracts

20-ECD 7-9% 4-Androstenedione 99%

Acetyl L-Carnitine HCI 99% Adenophora Tefraohylla Ext 5:1

Alisma Extract 10:1 Alpha Lipoic Acid 99%

Angelica Root Extract Arbutin 99%

Artemisia Extract 4: 1 Artichoke Exfract 5%, Globe

Asparagus Extract 4:1 Asparagus Powder

Astragulus Extract 10:1 Asfragulus Extract 4:1

Asfragulus Exfract 5:1 Astragulus Root Extract 0.5%

Astragulus Root Powder Atractylodes Extract 10:1

Avena Sativa Extract 10:1 Avena Sativa Extract 4: 1

Barbed Skullcap Extract 10:1 Barbeny Extract 10%

Bee Pollen Powder Beta-Sisterol 35%

Bilbeny Extract 10:1 Bitter Melon Extract 8:1

Black Cohosh Extract 2.5%) Black Cohosh Root Powder

Black Pepper Exfract 4:1 Black Soy Bean Extract 10:1

Bone Powder Boswellia Senata Extract 65%

Broccoli Sprout Extract 10:1 Buchu Leaf Powder

Buplerum (Chai Hu) Exfract 5:1 Burdock Root Exfract 4: 1

Cabbage Extract 4:1 Caffeine (Natural) 86-87%

Caffeine 99% Calcium Citrate Granular 21%

Calcium-Pyruvate 99% Canot Root Extract 4: 1

Cassia Nomame Extract 4: 1 Catnip Exfract 4:1

Cat's Claw (Inner Bark) Powder Cauliflower Extract 4: 1

Celandine (Greater) Extract 4:1 Celery Seed Extract

Cetyl Myristoleate 11% Cetyl Myristoleate 20%

Chaenomeles Extract 4:1 Chamomile Flower Extract 10:1

Chamomile Flower Extract 4:1 ChasteTree Beny Exfract 4: 1

Cl itin Chitosan 80%

Chitosan 90% Chondroitin Sulfate 90%

Chrysin 99% Cinnamon Powder

Cistanches Extract 5:1 Citrus Aurantium Extract 6%

Citrus Bioflavonoid Complex 13% Citrus Peel Extract 5:1

Clove Extract 5:1 Clove Powder

Coca Extract 4:1 Codonopsis Pilosula Extract 5:1

Colostrum Common Peony Extract 8:1

Cordyceps Extract 7% Cornsilk Extract 4:1

Cornsilk Powder Corydalis Exfract 10:1

Cranbeny Extract 4:1 Cranberry Powder

Curcumin Extract 95% Cuscuta Exfract 5:1

Damiana Extract 4: 1 Damiana Leaves Powder

Dandelion Powder Dandelion Root Extract 6: 1

Danshen Extract 80% D-Calcium Pantothenate

Devil's Claw Exfract 2.5% Devil's Claw Extract 4:1

Devil's Claw Root Powder DHEA 99%

Diosgenin 95% DL-Phenyl Alanine DMAE Bitartrate Dong Quai Extract 10:1

Dong Quai Extract 4: 1 Dong Quai Root Powder

D-Ribose Echinacea Angustifolia Extract 4: 1

Echinacea Leaf Powder Echinacea Puφurea Exfract 10:1

Echinacea Puφurea Extract 4% Echinacea Puφurea Extract 4:1

Echinacea Puφurea Root Powder Elder Flower Extract 4: 1

Elderbeny Exfract 20: 1 Elderbeny Extract 4:1

Epimedium Exfract 10%> Epimedixim Extract 10:1

Epimedium Exfract 4: 1 Epimedium Exfract 5%

Epimedium Powder Eucommia (Du Zhong) Extract 5:1

Fennel Seed Exfract 4:1 Fennel Seed Powder

Fenugreek Extract 4: 1 Fenugreek Extract 6:1

Feverfew Extract 5:1 Fisetin

Fish Oil Powder Forbidden Palace Flower Extract 5:1

Forskolin 8% Fo-Ti Exfract 12:1

Fo-Ti Extract 8:1 Fo-Ti Powder

Gardenia Extract 8:1 Garlic Extract 4:1

Garlic Powder Gentian Root Extract 6:1

Ginger Extract 4:1 Ginger Root Exfract 5%

Ginger Root Powder Ginkgo Biloba Extract 8:1

Ginkgo Extract 2416% Ginkgo Exfract 24/6%<5

Ginkgo Extract 24/7%. Ginkgo Leaf Exfract 4:1

Ginkgo Leaf Powder Ginseng (Korean) Powder

Ginseng (Panax) Extract 5% Ginseng (Panax) Extract 8%

Ginseng (Panax) Extract 80% Glucomannans Konjac Powder

Glucosamine HCI 95% Granulation Glucosamine HCI 99%

Glucsosamine Sulfate Potassium Glucsosamine Sulfate Sodium 95%. Granulation

Glucsosamine Sulfate Sodium 99% Goldenrod Extract 4: 1

Goldenrod Powder Goldenseal Root Extract 14%

Goldenseal Root Powder Gotu Kola Extract 16%

Gotu Kola Exfract 4:1 Gotu Kola Extract 8:1

Gotu Kola Powder Grape Fruit Powder

Grape Seed Grape Seed Extract 10:1

Grape Seed Extract 20:1 Grape Seed Extract 4: 1

Grape Seed Extract 5:1 Grape Seed Exfract 95%

Grape Seed Powder Grape Skin Extract 20: 1

Grape Skin Extract 4: 1 Grass-Leaved Sweetflai Extract

Green Lip Mussel Extract Green Tea Exfract 30%

Green Tea Extract 4:1 Green Tea Extract 95%,

Guarana Seed Exfract 10% Guarana Seed Extract 22%

Guarana Seed Extract 25% Guggul Exfract 10%

Guggul Extract 2.5%. Gugulipid Extract 10%

Gymnema Sylvestre Extract 25% Gymnema Sylvestre Powder

Hawthorne Beny Extract 4: 1 Hawthorne Beny Powder

Hawthorne Leaf Exfract 2% Hearbacious Peony Extract 5:1

Hesperidin Extract 98% Honeysuckle Herb Extract 4:1

Hops Flower Extract 4: 1 Horehound Extract 10:1

Horehound Extract 4: 1 Horehound Herb Powder

Horse Chestnut Extract 20% Horse Chestnut Extract 4:1

Horse Chestnut Powder Horsetail Extract 7% Horsetail Powder Houttuynia Cordata Extract 5:1

Hydrangea Exfract 8 : 1 Hydroxy Apatite

Hyssop Extract 4:1 hιdole-3-Carbinol 99%

Isodon Glaucocalyx Exfract 10:1 Japanese Knotweed Extract

Jiaogulan Extract 4:1 Jin Qian Cao Extract 4:1

Jingjie Exfract 4:1 Jujube Fruits Extract 4:1

Kava Kava Extract 30% Kava Kava Powder

Kelp Extract 4:1 Kelp Powder

Kidney Bean Extract 10:1 Kidney Bean Pole 4: 1

Kidney Bean Pole 8:1 Kidney Bean Powder

Kola Nut Exfract 10% Kudzu Extract 4:1

Kudzu Extract 6:1 Lettuce Exfract 4:1

L-Glutamine L-Glycine

Licorice Extract 10% Licorice Exfract 5:1

Licorice Powder Lotus Leaf Powder

L-Tyrosine Lycium Fruit Extract 4: 1

Lycium Fruit Extract 5:1 Ma Huang Extract 6%

Ma Huang Extract 8% Maca Extract 0.6%

Maca Extract 4:1 Maca Root Powder

Magnesium Stearate Magnolia Bark Powder

Magnolia Officinal Exfract 4:1 Maitake Mushroom Extract 4:1

Marigold Extract (Lutein 5%) Methozyisoflavone 99%

Methylsufonylmethane 99% Milk Thistle Exfract 4:1

Milk Thistle Seed Extract 80% silymarin Morinda Exfract 5 : 1

Motherwort Extract 4:1 Motherwort Powder

Mucuna Pruriens Exfract (15% L-Dopa) Muira Puama Extract 12:1

Muira Puama Extract 4: 1 Muira Puama Powder

Mushroom Extract 10:1 (feishi) Mustard Seed Extract 8:1

Myrobalan Exfract 4: 1 Mynha Gum Extract 2.5%

N-Acetyl-D-Glucosamine N-Acetyl-L-Cysteine

Nettle Extract 7% Nettle Leaf Extract 4:1

Nettle Leaf Powder Noni Powder

Olive Leaf Extract 18% Olive Powder

Orange Peel Extract 4:1 Orange Peel Powder

Oroxylum h dicum Extract 4: 1 Oroxylum fridicum Powder

Oyster Meat Powder Oyster Shell Powder

Papaya Fruit Extract 4: 1 Parsley Extract 10:1

Parsley Extract 4:1 Parsley Leaf Extract 4:1

Parsley Powder Passion Flower Extract 4:1

Passion Flower Powder Pau D'Arco Powder

Peppermint Extract 4: 1 Peppermint Powder

Perilla Seed Extract 4:1 Periwinkle Exfract 4: 1

Pharbitidis Extract 4:1 Phosphatidyl Serine 20%

Pine Bark Extract 4: 1 Plantago Asiatica Leaf Extract 5:1

Polygala Tenoifolia Extract 4: 1 Polygonum Extract

Polygonum Extract 4: 1 Pregnenolone 99%

Propolis Extract 3% Pseudoginseng Extract

Psyllium extract 4:1 Pumpkin Seed Exfract 4: 1

Puφle Willow Bark Extract 4: 1 Purslane Herb Extract 4:1

Pygeum Extract 4: 1 Quercetin Radish Extract 4:1 Radix Isatidis Extract 4:1

Radix Polygoni Exfract 4:1 Red Clover Exfract 4:1

Red Pepper Extract 4:1 Red Yeast Rice

Red Yeast Rice Exfract 10:1 Red Yeast Rice Powder

Rehmannia Root Exfract 4: 1 Reishi Mushroom Exfract 4:1

Rhodiola Rosea Exfract 4:1 Rhododendron Extract 4:1

Rhododendron Powder Rhubarb Exfract 4:1

Rhubarb Root Powder Riboflavin (B2)

Rice Powder Rosemary Extract 20%

Rumex Madaid Extract 4:1 Salvia Extract 10:1

Salvia Extract 4:1 SAMe

Saw Palmetto Extract 25%. Saw Palmetto Extract 25%

Saw Palmetto Extract 25% Saw Palmetto Extract 4: 1

Saw Palmetto Extract 45-50% Saw Palmetto Oil 85-95%

Saw Palmetto Powder Schizandra Extract 10:1

Schizandra Extract 4: 1 Scopolia Acutangula Powder

Sea Cucumber Powder Senna Leaf Powder

Sesame (Black) Seed Powder Shark Cartilage Powder

Shitake Mushroom Extract Siberian Ginseng Extract 0.8%

Siberian Ginseng Extract 4:1 Siberian Ginseng Powder

Skullcap Exfract 4:1 Skullcap Extract 4:1

Slippery Elm Powder Sodium-Pyruvate 99%.

Songaria Cynomorium Extract 4:1 Songaricum Powder

Spirulina Powder St. John's Wort Exfract 0.3%

St. John's Wort Exfract 4:1 St. John's Wort Powder

Stanol 50% Stephania Extract 4:1

Stevia Extract 4:1 Sulfate N+

Suma Root Extract 4:1 Suma Root Powder

Taurine Powder Thorowax Extract 4:1

Tomato Extract Tomato Exfract (0.2% Lycopene)

(frans)-Resverafrol 20-25% Tribulus Extract 10:1

Tribulus Extract 40% Tribulus Powder

Trifal Extract 4:1 Turmeric Exfract 4: 1

Turmeric Root Powder Uva Ursi Exfract 4: 1

Uva Ursi Powder Valerian Root Exfract 0.8%

Valerian Root Extract 4:1 Valerian Root Powder

Vinca Major Seed Extract 10:1 White Wax Extract 4:1

White Willow Bark 15% (total salicins) White Willow Bark 20%

White Willow Bark 25% White Willow Bark Extract 4:1

White Willow Bark Powder Wild Yam Exfract 10:1

Wild Yam Extract 16% Wild Yam Exfract 4:1

Wild Yam Extract 6% Wild Yam Powder

Williams Elder Extract 4: 1 Wolfberry Fruit Exfract 10:1

Wolfiporia Exfract 8:1 Yellow Dock Root Extract 4: 1

Yerba Mate Extract (2% caffeine) Yerba Mate Exfract 4:1

Yohimbe Bark Extract 15:1 Yohimbe Bark Exfract 2%

Yohimbe Bark Extract 3%> Yohimbe Bark Powder

Yucca Exfract 4:1 Enzymes

Alpha Galactosidase Amylase

Bromelain Cellulase

Papain Peptidase

Protease Proteolytic Enzymes

Superoxide Dismutase Trypsin

Phospholipids

Lecithin Phosphatidyl choline Phosphatidyl Serine

Specialty Nutraceuticals

5-Hydroxytryptophan Acetyl L-Carnitine

Alpha Lipoic Acid Alpha-Ketoglutarates

Bee Products Betaine Hydrochloride

Bovine Cartilage Caffeine

Cetyl Myristoleate Charcoal

Chitosan Choline

Chondroitin Sulfate Coenzyme Q10

Collagen Colostrum

Creatine Cyanocobalamin (Vitamin B12)

DMAE Fumaric Acid

Germanium Sesquioxide Glandular Products

Glucosamine HCL Glucosamine Sulfate

HMB (Hydroxyl Methyl Butyrate) Immxmoglobulin (hnmime System Support)

Lactic Acid L-Carnitine

Liver Products Malic Acid

Maltose-anhydrous Mannose (d-mannose)

MSM Other Carnitine Products

Phytosterols Picolinic Acid

Pyruvate Red Yeast Extract

SAMe Selenium Yeast

Shark Cartilage Theobromine

Vanadyl Sulfate Velvet Deer Antler

Yeast

Herbal Oils

Aloe Vera Artichoke Oil

Artichoke Oil Black Cunant Seed Oil 14% GLA

Black Cunant Seed Oil 15% GLA Borage Oil 20% GLA

Borage Oil 22% GLA Boswellia Senata Oil CLA Conjugated Linolic Acid 75% min. Evening Primrose Oil 10% GLA

Evening Primrose Oil 9% GLA Flax Seed Oil 50% ALA

Garlic Oil Grape Seed Oil

Guggul Lipid Oil Olive Leak Exfract

Oregano Oil Perilla Oil 60% ALA

Pumpkin Seed Oil Pygeum Oil

Rosehip Oil Rosemary Oil

Saw Palmetto Oil Sterols

Tocotrienol Palm Oil Walnut Oil

Wheat Germ Oil Sesame Seed Oil

Dill Seed Oil

Clove Bud Oil

Ginger Root Oil

Cinnamon Leaf Oil

Fennel Seed Oil

Curcuma Longa Oil

Cummin Seed Oil

Celery Seed Oil

Coriander Seed Oil

Red Rasbeny Seed Oil Cranberry Seed Oil Blackberry Seed Oil

Marine Oils

Cod Liver Oil ( 1000 A /100 D ) Cod Liver Oil ( 2500A / 250D ) Fish Oil 30% EPA / 20% DHA Fish Oil Concentrated Fish Oil Deodorized Marine Lipid Oil 18/12 Marine Lipid Oil 30/20 Marine Lipid Oil 36/24 Salmon Oil 18% EPA / 12% DHA Squalene Oil ( Shark )

Other Oils

Alpha Lipoic Acid Cetyl Myristoleate CM

Coenzyme Q10 . Lecithin

Medix i Chain Triglycerides MCT

Vitamins

Ascorbic Acid (Vitamin C) B Vitamins

Biotin Fat Soluble Vitamins

Folic Acid HCA (Hydroxycitric Acid) hiositol Mineral Ascorbates

Mixed Tocopherols Niacin (Vitamin B3)

Orotic Acid PABA (Para-Aminobenzoic Acid)

Pantothenates Pantothenic Acid (Vitamin B5)

Pyridoxine Hydrochloride (Vitamin B6) Riboflavin (Vitamin B2) Synthetic Vitamins Thiamine (Vitamin Bl)

Tocotrienols Vitamin A

Vitamin D Vitamin E

Vitamin F Vitamin K

Vitamin Oils Vitamin Premixes

Vitamin-Mineral Premixes Water Soluble Vitamins

Carotenoids

Apocarotenal Astaxanthin Beta-Carotene Canthaxanthin Carotenoids Lutein / Lutein Esters Lycopene Zeaxanthin

Hormones

7-Keto-DHEA Androstenedione DHEA Melatonin

Nor-Androstenedione Pregnenolone Progesterone 19 Nor-4-Androstendiol

19 Nor-4- Androstenedione

19 Nor-5-Androstenediol

19 Nor-5-Androstendione

3-Indolebutyric Acid

4 Androstendiol

4 Androstendione

6 Furfurylaminopurene

6-Benzylaminopurine

Minerals

Boron Calcium

Chelated Minerals Chloride

Chromium Coated Minerals

Cobalt Copper

Dolomite Iodine

Iron Magnesium

Manganese Mineral Premixes

Mineral Products Molybdenum

Other Minerals Phosphorus

Potassium Selenium

Sodium Specialty Minerals

Trace Minerals Vanadium

Zinc Malic Acid

Pyruvate Probiotics

Acidophilus Bifido Bacteria Lactobacillus

Proteins / Amino Acids

Amino Acids Betaine

Casein Functional Soy

Glutamic Acid L- Alanine

L- Arginine L-Cysteine

L-Glutamine L-Glycine

L-Histidine L-Isoeucince

L-Leucine L-Lysine

L-Methionine L-Ornithine

L-Phenylalaline L-Proline

L-Taurine L-Threonine

L-Tryptophan L-Tyrosine

L-Valine N-Acetly-L-Cysteine

Protein Soluble Soy

Soy Protein Isolates Textured Soy

Whey Protein Isolates

Specialty Nutrients

ATP

Forskolin Sterol Esters

Stanol Esters

Probiotics

Lactoferin

Lutein Esters Zeaxanthin

Immunoglobulins

Ipriflavone

Isoflavones

Fructo-Oligo-Saccharides Inulin

Huperzine A

Melatonin

Medicinal Mushrooms

Bile Products Peptone Products

Glandular Products

Pancreatic Products

Thyroid Products Ribose Probiotics

Oleo Resins

Dill Seed Oleo Resin Black Pepper Oleoresin Capsicum Oleoresin

EXAMPLES XI

The present invention further contemplates the use of any active ingredients or medicaments known in the art. In this regard, it is well within the purview ofthe skilled artisan to select a particular combination of active ingredients or medicaments. The following non-limiting lists illusfrate exemplary active ingredients or medicaments and the broader subclasses and classes to which they belong for use in this invention.

MEDICAMENTS ACTING ON THE AUTONOMIC NERVOUS SYSTEM

Adrenergic Medicaments Cholinergic Medicaments

Direct Muscarinic Agonists Choline Esters acetylcholine bethanechol (Urecholine) carbachol methacholine (Provocholine)

Alkaloids muscarine pilocarpine (Pilocar) Direct Nicotinic Agonist nicotine

Acetylcholinesterase Inhibitors Acetylcholinesterase Inhibitors ("Reversible") edrophonium (Tensilon) neostigmine (Prostigmin) physostigmine (Antilirium) Acetylcholinesterase Inhibitors ("Irreversible")

(diisopropylflurorphosphate DFP) echothiophate (Phospholine) isoflurophate (Floropryl) Muscarinic Antagonists Atropine ipratropium (Atrovent) pirenzepine scopolamine 2-PAM: Acetylcholinesterase Reactivator Pralidoxime (Protopam) {2- PAM} peripheral acetylcholinesterase reactivator for certain phosphoryl-enzyme complexes Ganglionic Blockers hexamethonium mecamylamine (Inversine) trimethaphan Catecholamines dobutamine (Dobutrex) dopamine (Intropin) epinephrine isoproterenol (Isuprel) norepinephrine (Levophed) Direct Adrenoceptor Agonist Medicaments albuterol (Ventolin, Proveritil) clonidine (Catapres) methoxamine (Vasoxyl) oxymetazohne (Afrin) phenylephrine (Neo-Synephrine) ritodrine (Yutopar) salmeterol (Serevent) terbutaline (Brethine) Indirect-Acting Sympathomimetic Medicaments amphetamine cocaine ephedrine, Pseudoephedrine tyr amine Alpha- Adrenoceptor Antagonists Medicaments doxazosin (Cardura) labetalol (Trandate, Normodyne) phenoxybenzamine (Dibenzyline) phentolamine (Regitine) prazosin (Minipress) terazosin (Hytrin) tolazoline (Priscoline) trimazosin yohimbine (Yocon) β- Adrenoceptor antagonist Medicaments atenolol (Tenormin) butoxamine esmolol (Brevibloc) labetalol (Trandate, Normodyne) metoprolol (Lopressor) nadolol (Corgard) pindolol (Visken) propranolol (lnderal) timolol (Blocadren) Adrenergic Neuron Blocking Medicaments guanethidine (Ismelin) reserpme

CARDIOVASCULAR SYSTEM DISORDERS

Cardiovascular testing and diagnosis Hypertension (HTN)

Heart Failure lschemic Heart Disease

Myocardial Infarction

Arrhythmias Isolated Diastolic Heart Failure and Cardiomyopathies

Cardiac Transplantation

Venous Thromboembolism

Stroke

Hyperlipidemia Peripheral vascular disease

Diuretics carbonic-anhydrase inhibitors loop diuretics osmotic diuretics potassium sparing diuretics thiazide diuretics

Anitiarrhythmic Medicaments Sodium Channel blocking agents isopyramide (Norpace) flecainide (Tambocor) ibutilide lidocaine (Xylocaine) mexiletine (Mexitil) moricizine (Ethmozine) procainamide (Pronestyl, Procan) propafenone (Rythmol) quinidine tocainide (Tonocard)

Calcium Channel blocking agents bepridil (Vasocor) diltiazem (Cardizem) verapamil (Isoptin, Calan) Adrenergic receptor antagonists propranolol (Inderal) Other medicaments adenosine (Adenocard) amiodarone (Cordarone) bretylium (Bretylol) disopyramide (Noφace) esmolol (Brevibloc) sotalol (Betapace) Hypolipidemic medicaments

HMG CoA Reductase Inhibitors atorvastatin (Lipitor) cerivistatin (Baycol) lovastatin (Mevacor) pravastatin (Pravochol) simvastatin (Zocor) Bile-acid sequestrants cholestyramine (Questran) colestipol (Colestid)

Fibric acids clofilbrate fenofibrate (Tricor) gemfibrozil (Lopid) niacin, nicotinic acid probucol (Lorelco) Antihypertensive medicaments

Adrenergic receptor antagonists acebutalol (Sectral) atenolol (Tenormin) betaxolol (Betoptic) bisoprolol (Zebeta) carteolol (Cartrol) clonidine (Catapres) labetalcl (Normodyne) metoprolol (Toprol) penbutalol (Levatol) pindolol (Visken) prazosin (Minipres) propranolol (Inderal) terazosin (Hytrin) timolol (Timoptic) Calcium Channel Antagonists amlodipine (Norvasc) diltiazem (Cardizem) felodipine (Plendil) isradipine (Dynacirc) nicardipine (Cardene) nifedipine (Procardia) nimodipine (Nimotop) nisoldipine (Sular) verapamil (Isoptin, Catan) Angiotensin Converting Enzyme (ACE) Inhibitor benazepril (Lotensin) bepridil (Vascor) captopril (Capoten) enalapril (Vasotec) fosinopril (Monopril) lisinopril (Prinivil, Zestril) moexipril (Univasc) quinapril (Accupril) ramipril (Altace) Angiotensin II Receptor Antagonists losartan (Cozaar) valasartan (Diovan) Diuretics amiloride (Midamor) bumetanide (Bumex) chlorothalidone (Hygroton) ethacrynic acid (Edecrin) furosemide (Lasix) hydrochlorothiazide (Diuril) indapamide (Lozol) metolazone (Zaroxolyn) torsemide (Demadex) triamterene Other Agents hydralazine (Apresoline) minoxidil (Rogaine) nitroprusside (Nipride) prazosin (Minipres) reseφine sotalol (Brevibloc) spironolactone (Aldactone) terazosin (Hytrin) Antianginal medicaments

Organic nitrates Calcium Channel Antagonists

Adrenergic Receptor Antagonists amyl nitrite erythrityl tetranitrate isosorbide dinitrate (Isordil) nitroglycerin pentaerythritol tetranitrate Congestive Heart Failure Medicaments phosphodiesterase (PDE) inhibitors amrinone (Inocor) milrinone (Primacor) carvedilol (Coreg) cardiac glycosides digitoxin digoxin diuretics

ACE Inhibitors

Dobutamine dopamine RESPIRATORY SYSTEM DISORDERS

Asthma

Chronic Obstructive Lung Disease (COLD) / Chronic Obstructive Pulmonary Disease (COPD)

Acute Respiratory Distress Syndrome (ARDS)

Drug-Induced Pulmonary Disease

Cystic Fibrosis Corticosteroids beclomethasone betamethasone cortisone dexamethasone fluticasone (Flovent / Flonase) hydrocortisone methylprednisolone prednisolone prednisone triamcinolone sympathomimetics albuterol (Proventil / Ventolin) salmeterol (Serevent) muscarinic antagonists ipratropium (Combivent) leukotriene pathway inhibitors montelukast (Singulair) zafirtukast (Accolate) mast cell stabilizers cromolyn (Intal) methylxanthines theophylline aminophylline Dnase (Pulmozyme)

GASTROINTESTINAL SYSTEM DISORDERS

Gastro-esophageal Reflux Disease (GERD)

Peptic Ulcer Disease

Inflammatory Bowel Disease

Nausea and Vomiting Diarrhea, Constipation, Irritable Bowel Disease (IBD)

Portal Hypertension and Cirrhosis

Drug-Induced Liver Disease

Pancreatitis

Viral Hepatitis Liver Transplantation

Histamine-2 receptor antagonists famotidine (Pepcid) nizatidine (Axid) pantoprazole (Protonix) rabeprazole (Aciphex) ranitidine (Zantac) Proton Pump Inhibitors (PPIs) esomeprazole (Nexium) lansoprazole (Prevacid) omeprazole (Prilosec) Anti-nausea / anti- vertigo medicaments anticholinergics antihistamines (Histamine- 1 receptor antagonists) dopamine antagonists prokinetic gastric stimulant serotonin 5HT₃ receptor antagonists dolasetron (Anzmet) granisetron (Kytril) ondansetron (Zofran) other medicaments hydroxyzine (Atarax, Vistaril) corticosteroids benzodiazepines cannabinoids Prokinetic gastric stimulants (gastric motility stimulants) cisapride (Propulsid)) metoclopramide (Reglan)

Laxatives

Saline laxatives magnesium salts sodium salts irritant / stimulant medicaments cascara senna phenolphthalein bisacodyl casanthranol castor oil bulk-producing medicaments methylcellulose psyllium polycarbophil lubricant mineral oil surfactants docusate miscellaneous glycerin lactulose Anti-diarrheal medicaments diphenoxylate atropine diphenoxin loperamide bismuth lactobacillus Ulcerative Colitis Medicaments mesalamine olsalazine

RENAL SYSTEM DISORDERS Acute Renal Failure Progressive Renal Failure / Chronic Renal Failure

NEUROLOGIC SYSTEM DISORDERS

Multiple Sclerosis and inflammatory polyneuropathies Epilepsy

Parkinson's disease and Movement Disorders Pain management Headache

Amyotrophic Lateral Sclerosis

Anti-epileptic medicaments carbamazepine (Tegretol) divalproex sodium (Depakote) felbamate (Felbatol) gabapentin (Neurontin) lamotrigine (Lamictal) oxcarbazepine (Trileptal) phenytoin (Dilantin) topiramate (Topamax) zonisamide (Zonegran) Antimigraine medicaments

Serotonin 5HTιd receptor agonists almotriptan (Axert) frovatriptan (Frova) naratriptan (Amerge) rizatriptan (Rizalt) sumatriptan (Imitrex) zolmitriptan (Zomig) ergot alkaloids dihydroergotamine (DHE) isometheptine/dichlorophenazone (Midrin) caffeine pizotifen (Sanomigran)

Sedative-hypnotic Medicaments benzodiazepines alprazolam (Xanax) clonazepam (Kloriopin) clorazepate (Tranxene) diazepam (Valium) flumazenil (Romazicon) - antagonist lorazepam (Ativan) midazolam (Versed) triazolam (Halcion) barbiturates/Anesthetics pentobarbital (Nembutal) Phenobarbital (Luminal) thiopental (Pentothal) non-depressant anxiolytic buspirone (BuSpar) Treatment of alcoholism disulfiram (Antabuse)

Pain Management Medicaments Opioids

Opioid Peptides beta-endorphin dynorphin enkephalins Agonists codeine etorphine fentanyl (Sublimaze) hydrocodeine hydromoφhone rneperidine (Demerol) methadone (Dolophine) morphine oxycodone propoxyphene Agonist-antagonists buprenorphine Partial Agonist dezocine (Dalgan) nalbuphine (Nubain) pentazocine (Talwain) Antagonist naloxone (Narcan)

Non-opiate acetaminophen (tylenol) tramadol (ultram) Anti-Parkinsonism Medicaments levodopa carbidopa bromocriptine (Parlodel) pergolide (Permax) amantadine (Symmetrel) selegiline (Deprenyl) anticholinergic agents dopamine Agonists pramipexole (Mirapex) ropinirole (Requip)

COMT inhibitors entacapone (Comtan) tolcapone (Tasmar) Anti-Spasticity Medicaments baclofen (Lioresal) botulinum toxin type A (Botox) carisoprodol (Soma, Rela) chlorphenesin (Maolate) chlorzoxazone (Paraflex) cyclobenzaprine (Flexeril) dantrolene (Dantrium) diazepam (Valium) metaxalone (Skelaxin) methocarbamol (Robaxin) orphenadrine (Nor-flex) tizanidine (Zanaflex)

PSYCHIATRIC SYSTEM DISORDERS Childhood psychiatric disorders

Attention Deficit Hyperactivity Disorder (ADHD) / Attention Deficit Disorder (ADD) Eating disorders

Alzheimer's disease and Dementia Disorders Substance abuse and Addictive Disorders alcohol, tobacco and caffeine abuse Schizophrenia Depressive disorders Bipolar disorders Anxiety disorders

Obsessive-Compulsive disorders Sleep disorders

Psychostimulant Medicaments amphetamine mixed salts (Adderall) dextroamphetamine (Dexedrine) methylphenidate (Ritalin, Concerta) Antipsychotic Medicaments (dopamine antagonists) Phenothiazine type chloφromazine (Thorazine) fluphenazine (Prolixin) Thioxanthene type thiothixene (Navane) Butyrophenone type haloperidol (Haldol) Dibenzodiazepine type clozapine (Clozaril) Thienobenzodiazepine type olanzapine (Zyprexa) quetiapine (Seroquel) Antidepressant Medicaments

Tricyclic antidepressants (TCA's) amitriptyline (Elavil, Endep) clomipramine (Anafranil),also a SSRI desipramine (Norpramin) doxepin (Sinequan) imipramine (Tofranil) maprotiline (Ludiomil) nortriptytine (Aventyl, Pamelor) protriptyline (Vivactil) Monoamine oxidase inhibitors (MAO-I's) clorgyline (specific for MAO type A) isocarboxazid (Marplan) phenelzine (Nardil) tranylcypromine (Parnate) Second Generation Medicaments (not including SSRIs) amoxapine (Asendin) bupropion (Wellbutrin) netazodone (Serzone) trazodone (Desyrel) Serotonin-Specific Reuptake Inhibitors (SSRIs) citalopram (Celexa) clomipramine (Anafranil) escitalopram (Lexapro) fluoxetine (Prozac) fluvoxamine (Luvox) paroxetine (Paxil) sertraline (Zoloft)

Other lithium mirtazapine (Temeron) venlafaxine (Effexor) Anti-anxiety agents barbiturates benzodiazepines buspirone (Buspar) chloral hydrate doxepin hydroxyzine sedative-hypnotics serotonin reuptake inhibitors Anti-demential Medicaments cholinesterase inhibitors donepezil (Aricept) galantamine (Reminyl) rivastigmine (Exelon) tacrine (Cognex)

ENDOCRINOLOGIC SYSTEM DISORDERS

Diabetes mellitus Thyroid disorders Adrenal Gland disorders

Pituitary Gland disorders

ACTH

Adrenal androgens Adrenocortical Function Antagonists

Mineralocorticoid antagonists

Anti-Diabetic Medicaments

Insulin Sulfonylureas acetohexamide (Dymelor) chlorpropamide (Diabinese) glimepiride (Amaryl) glipizide (Glucotrol) glyburide (Micronase, DiaBeta) tolazamide (Tolinase) tolbutamide (Orinase) Biguanides metformin (Glucophage) Alpha-glucosidase Inhibitors acarbose (Precose) miglitol (Glyset) Thiazolidinedione Derivatives pioglitazone (Actos) rosiglitazone (Avandia) troglitazone (Rezulin) Thyroid Disorder Medicaments Levothyroxine Liothyronine Liotrix

Hypothalamic and Pituitary Gland Medicaments bromocriptine (Parlodel) chorionic gonadotropin (hCG) corticotropin generic (ACTH) cosyntropin (Cortrosyn) desmopressin (DDAVP) gonadorelin acetate (GnRH) (Lutrepulse) gonadorelin hydrochloride (GnRH) (Factrel) goserelin acetate (Zoladex) growth hormone histrelin (Supprelin) leuprolide (Lupron) menotropins (hMG) (Pergonal, Humegon) natarelin (Synarel) octreotide (Sandostatin) oxytocin (Pitocinit, Syntocinon) pergolide (Permax) protirelin (Thypinone, Relefact TRH) sermorelin (GHRH) (Geref) somatrem (Protropin) somatropin (Humatrope, Nutropin) thyrotropin (TSH) (Thytropar) urofollitropin (Metrodin) vasopressin (Pitressin Synthetic)

GYNECOLOGIC SYSTEM AND OBSTETRIC CONDITIONS

Pregnancy and Lactation Infertility

Contraception

Menstruation-related disorders

Endometriosis

Hormone Replacement Therapy (HRT)

Conjugated estrogens (Premarin) desogestrel di-norgestrel ethinyl diacetate ethinyl estradiol levonorgestrel medroxyprogesterone norethindrone norgestimate progesterone

UROLOGIC SYSTEM DISORDERS

Erectile Dysfunction Benign Prostatic Hypertrophy Urinary Incontinence

apomorphine alprostadit phosphodiesterase (PDE-5) inhibitors sildenafil (Viagra) tadalafil (Cialis) vardenafil (Levitra) tolterodine (Detrol) tamulosin (Flomax) yohimbine

IMMUNOLOGIC SYSTEM DISORDERS

Systemic Lupus Erythematosus and other Collagen-vascular diseases Allergic and pseudo-allergic drug reactions

BONE AND JOINT SYSTEM DISORDERS

Osteoporosis and Osteomalacia Rheumatoid Arthritis Osteoarthritis

Gout and hyperuricemia

Medicaments used in the Control of Inflammation

Non-steroidal anti-inflammatory drugs (NSAIDs) aspirin diclofenac (Cataflam, Voltaren) diflusnisal (Dolobid) etodolac (Lodine) fenoprofen (Nalfon) flubiprofen (Ansaid) ibuprofen (Motrin, Advil, Nuprin) indomethacin (lndocin) ketoprofen (Orudis) ketorolac (Toradol) meclofenamate nabumetone (Relafen) naproxen (Naprosyn) oxaprozin (Daypro) phenylbutazone piroxicam (Feldene) salicytate sulindac (Clinoril) tolmetin (Tolectin) Cyclocxygenase-2 inhibitors (COX-2) celecoxib (Celebrex) rofecoxib (Vioxx) Arthritis and Gout Medicaments allopurinol anti-malarial compounds chloroquine colchicine enbrel

Glucocorticoids Gold methotrexate

NSAIDs Penicillamine Other Medicaments alendronate (Fosamax) raloxifene (Evista)

DISORDERS OF THE EYES, EARS, NOSE, AND THROAT SYSTEMS

Glaucoma Allergic rhinitis

Histamine- 1 receptor antagonists brompheniramine (Dimetane) cetirizine (Zyrtec) chloφheniramine (Chlor-Trimeton) clemastine (Tavist) cyproheptadine (Periactin) dimenhydrinate (Dramamine) diphenhydramine (Bendaryl) doxylamine (Sominex, Unisom) fexofenadine (Allegra) loratidine (Claritin) Sympathomimetic medicaments pseudoephedrine (Sudated)

DERMATOLOGIC SYSTEM DISORDERS

Acne Psoriasis

Rosacea and pigmentation disorders

HEMATOLOGIC SYSTEM DISORDERS Hematopoeisis

Anemias

Coagulation disorders Sickle-cell anemia Drug-induced hematologic disorders

Coagulation disorders Medicaments aspirin clopidogrel (Plavix) fibrinolytic inhibitors fibrinolytics glycoprotein (GP) ϋb/IIIa antagonists / monoclonal antibodies abciximab (Reopro) eptifibatide (Integrelin) tiofibran (Aggrastat) heparin low-molecular weight heparins Plasma fractions - blood factors ticlopidine (Ticlid) vitamin K warfarin (Coumadin)

INFECTIOUS SYSTEM DISEASES Central Nervous System (CNS) infections

Lower Respiratory Tract Infections

Upper Respiratory Tract Infections

Skin and Soft Tissue Infections

Infective Endocarditis Tuberculosis

Gastrointestinal Infections and Enterotoxigenic poisonings

Intra-abdominal Infections

Parasitic diseases

Urinary Tract Infections and Prostatis Sexually Transmitted Diseases

Bone and Joint Infections

Sepsis and Septic Shock

Superficial Fungal Infections

Invasive Fungal Infections Infections in Immunocompromised Patients

Antimicrobial prophylaxis in Surgery

Vaccines, toxoids, and other immunobiologics

Human Immunodeficiency Virus Infection

Medicaments used in Infectious diseases

Cell Wall Synthesis Inhibitors Penicillins amoxicillin (Amoxil Polymox) ampicillin (Principen, Omnipen) benzathine Penicillin G benzyl Penicillin (Penicillin G) carbenicillin (Geocillin) cloxacillin (Cloxapen) dicloxacillin (Dynapen) methicillin (Staphcillin) mezlocillin nafcillin (Nafcil, Unipen) oxacillin phenoxymethyl Penicillin (Penicillin V) piperacillin (PipracH) ticarcillin (Ticar) Cephalosporins

1st generation: cefazolin (Ancef, Defzol) cephalexin (Keflex) cephatothin (Keflin) 2nd generation: cefaclor (Ceclor) cefoxitin (Mefoxin) cefpodoxime (Vantin) cefuroxime (Zinacef, Ceftin) loracarbef (Lorabid) 3rd generation: cefoperazone cefotaxime (Claforan) cefotetan ceftazidime (Fortax, Taxidime, Tazicef) ceftriaxone (Rocephin) veftizoxime (Cefizox) 4th generation: cefepime Other beta-Lactams aztreonam (Azactan) clavulanic acid imipenem (Primaxin) meropenem (Merrem IV) sulbactam Other Cell- Wall Synthesis Inhibitors bacitracin cycloserine fosfomycin (Monurol) vancomycin (Vancocin) Agents Which Affect Cell Membranes Polymixins Colistimethate

Potymyxin B Protein Synthesis Inhibitors Aminoglycosides amikacin (Amikin) gentamicin (Garamycin) kanamycin (Kantrex) neomycin netilmicin (Netromycin) streptomycin tobramycin

Tetracyclines demeclocycline (Declomycin) doxycycline doxycyclmne (Vibramycin, Doryx) tetracycline (Achromycin)

Macrolides azithromycin (Zithromax) clarithromycin (Biaxin) erythromycin esters erythromycin Other Protein Synthesis Inhibitors

C loramphenicol (Chloromycetin) Clindamycin (Cleocin) Spectinomycin (Trobicin) Inhibitors of Folate-Dependent Pathways co-trimoxazole silver Sulfadiazine sodium Sulfacetamide sulfamethoxazole (Gantanol) sulfasalazine (Azulfidine) (Salicylazosulfapyridine) sulfisoxazole (Gantrisin) sulfonamides Dihydrofolate Reductase Inhibitor trimethoprim

DNA Gyrase Inhibitors ciprofloxacin (Cipro) gatifloxacin (Tequin) levofloxacin (Levaquin) lomefloxacin (Maxaquin) nalidixic acid ofloxacin (Floxin) Urinary Tract Antiseptics nitrolurantoin Antimyobacterial Agents

First-line anti-TB medicaments ethambutol isoniazid (INI-I) pyrazinamide rifampin (Rimactane) streptomycin Second-line anti-TB medicaments capreomycinA cycloserine dapsone ethionamide para-aminosalicylic acid AntiFungal Agents amphotericin B (Fungizone, Amphotec) clotrimazole (Mycelex) fluconazole (Diflucan) flucytosine griseofulvin itraconazole (Sporanox) ketoconazole (Nizoral) miconazole (Monistat) nystatin (Mycostatin) AntiParasitic Agents Antimalarials chloroquine (Aralen) mefloquine (Laria ) primaquine pyrimethamine-sulfadoxine (Fansidar) Anti protozoals metronidazole (Flagyl) pentamidine isethionate pyrimethamine-sulfonamide trimethoprim (generic) sulfamethoxazole (Gantanol)

Antihelminthic Medicaments mebendazole praziquantel (Biltricide) pyrantel pamoate thiabendazole (Mintezol)

Antiviral Medicaments acyclovir (Zovirax) didanosine (DDI) foscarnet (Foscavir) ganciclovir (DHPG, Cytovene) ribavirin rimantadine stavudine (d4T)) valacyclovir (Valtrex) vidarabine (Vira-A) zalcitabine (ddC) zidovudine (Azidothymidine, AZT) Protease inhibitors indinavir (Crixivan) ritonavir (Norvir) saquinavir (Fortovase)

ONCOLOGIC AND IMMUNOLOGICAL DISORDERS

Breast Cancer Lung Cancer

Colorectal Cancer

Prostate Cancer

Malignant Lymphomas

Ovarian Cancer Acute Leukemias

Chronic Leukemias

Melanoma and other Skin Cancers

Hematopoeitic Stem Cell Transplantation Anti-neoplastic Medicaments

Alkylating Agents busulfan (Myleran) carboplatin (Paraplatin) carmustine (BNCU,BiCNU) cisplatin (Platinol) cyclophosphamide (Cytoxan) ifofamide (Ifex) lomustine (CCNU,CeeNU) mechlorethamine (Mustargen) meiphalan (Alkeran) procarbazine (Matulane) thiotepa Antimetabolites folic acid Antagonist methotrexate Purine Antagonists 6-mercaptopurine 6-thioguanine Pyrimidine Antagonists cytarabine (ARA-C) fluorouracil (5-FU) Hormonal Agents: Hormones diethylstilbestrol (DES) estrogens prednisone (Deltasone) Modulation of Hormone Release & Action Aminoglutethimide leuprolide acetate tamoxifen (Nolvadex) Plant Alkaloids

Vinca Alkaloids vinblastine (Velban) vincristine (Oncovin) Podophyllotoxins Etoposide (VP-16)

Other docetaxel (Taxotere) paclitaxel (Taxol) Antibiotics bleomycin (Blenoxane) dactinomycin (Cosmegen) daunorubicin (DaunoXome) doxorubicin (Adriamycin) mitomycin (Mutamycin) Other Anti-neoplastic Medicaments amsacrine (AMSA) azathioprine (Imuran) capecitabine (Xeloda) chlorambucil (Leukeran) cyclosporine (Sandimmune, Neoral) gemcitabine (Gemzar) hydroxyurea (Hydrea) mitotane (Sodren) mitoxantrone (Novantrone) pamidronate (Aredia)

Immunosuppressant Medicaments 15-desoxyspergualin corticosteroids cyclosporine Interferons Interleukins mycophenolate mo etil sirolimus (rapamycin) tacrolimus thalidomide

NUTRITIONAL DISORDERS Malnutrition, vitamin and mineral deficiencies

Enteral Nutrition Obesity orlistat (Xenical) appetite suppressants sympathomimetic stimulants amphetamine stimulants Mineral supplementation calcium ion iodine iron magnesium ion phosphorous potassium ion selenium sodium ion zinc

Fat-soluble vitamins vitamin A vitamin D vitamin E vitamin K

Water-soluble vitamins vitamin C thiamine (vitamin Bl) riboflavin (vitamin B2) niacin (vitamin B3) pyridoxine (vitamin B6) folate cyanocobalamin (vitamin B12)

MEDICAMENTS USED TO ALLEVIATE SYMPTOMS OF ALLERGIC

RHINITIS, UPPER RESPIRATORY SYMPTOMS, COUGH, MILD ACHES AND PAINS

Nasal Decongestants ephedrine phenylephrine phenylpropanolamine pseudoephedrine Antihistamines (Histamine- 1 receptor antagonists) Antitussive agents benzonatate codeine dextromethoφhan Expectorants guaifenesin iodinated glycerol teφin hydrate Xanthines aminophylline caffeine dyphylline theophylline Pain relievers narcotic agonists

NSAIDS acetam inophen

DIETARY SUPPLEMENTS

Arnica

Bilberry

Black Cohosh

Cat's claw Chamomile

Echinacea

Evening Primrose Oil

Fenugreek

Flaxseed Feverfew

Garlic

Ginger root

Ginkobiloba

Ginseng Goldenrod

Hawthorn

Kava-Kava

Licorice

Milk thistle Psyllium

Rauwolfia

Senna

Soybean

St. John's wort Saw palmetto

Turmeric

Valerian THERAPEUTIC PROTEINS and Biotechnology Medicaments

Additional Agents: Norvasc, Neurontin, Paxil, Augmentin, Propecia, Lamisil, Lescol, bisphosphonate.

EXAMPLES XH As can be seen above, various embodiments ofthe present invention can be utilized in specific medical applications. By way of example only and not by way of limitation, the present invention can be practiced to prepare delivery devices for use in chemotherapy to address/treat, by way of example and not by limitation, the following aspects of chemotherapy: psychological, timing (to coincide with tumor growth for example) route of administration, nausea, vomiting (CINV), compliance, and cost (e.g. reduce hospital management of patients, reduce the number of "repeat" drug doses due to patient vomiting, etc.). Still futher, the just mentioned aspects are not limited to chemotherapy, as the present invention can be practiced to address common aspects between chemotherapy and other treatments.

Further by way of examples, capsules containing Zofran (ondanserfron), Temodar (temozolomide) can be made. Still further, the present invention can be used in cardiovascular treatments, for example hypertension, heart failure, and heart rhythm disorders. Also, the present invention can be used in immunology (e.g. transplant rejections, auto-immune disorders, etc.). The present invention can be used to treat neurological disorders (such as Parkinson's disease, dementia, stroke, epilepsy, and migraine headache, etc.), psychiatric disorders (schizophrenia, bipolar disease, depression, anxiety, ADHD / ADD, Addictions, etc.), infectious diseases (fungal, bacterial, viral (HIV), etc.), and in anesthesiology (induction anesthesia, local anesthesia). Furthermore, the present invention has application in endocrinology (cholesterol, diabetes, hormone replacement therapy, thyroid dysfunction, oral contraception, obesity, etc.), dermatology (onychomycosis, acne, rosaceae, psoriasis, etc.), rheumatology (arthritis, gout, osteoporosis / Osteomalacia), respiratory fields (asthma, emphysema, cystic fibrosis, etc.), gasfro-intestinal fields (gastro-esophageal reflux disease, ulcer prophylaxis, crohn's disease, inflammatory bowel disease, etc.), chronic renal failure (vitamin and mineral replacement, blood pressure regulation, diabetes, depression, etc.), genito-urinary (enlarged prostate / BPH, overactive bladder, erectile dysfunction, feminine yeast infections, etc.) and hematology-oncology (thromboembolous, hermatopoeisis, neoplastic disease, nausea / vomiting).

EXAMPLES XIII

The present invention can be utilized with a variety of exipients. Categories of exipients include, but are not limited to, Binders, Dismtegrants Fillers (diluents), Lubricants, Glidants (flow enhancers), Compression aids, Colors, Sweeteners, Preservatives, Suspensing/dispersing agents, Film formers/coatings, Flavors, and Printing inks. Still furhter by way of example and not by limitation, the present invention can be utilized with the following exipients:

Magnesium Stearate Povidone

Lactose Pregelatinized Starch

Microcrystalline Hydroxy Propyl Cellulose Methylcellulose

Starch (corn) OPA products (coatings

& inks)

Silicon Dioxide

Croscarmellose

Titanium Dioxide

Hydroxy Propyl Cellulose

Stearic Acid

Ethylcellulose

Sodium Starch

Glycolate Calcium Phosphate

(dibasic)

Gelatin

Crospovidone

Talc

Shellac (and Glaze)

Sucrose

Calcium Stearate

EXAMPLES XIV

Examples ofthe supporting nutraceutical formulations are to illustrate examples where specific categories ofthe natural products industry can be utilized with the present invention. There are many more categories than the ones that are listed and therefore this is for simply for the puφose to show that the technology is broad and could be utilized for many specific categories. The specific mg of each product is not included due to the amounts of each material is typically based upon the formulators opinions, however there are some (RDA) recommended daily allowances that could be used to determine the formulation.

Category: Antioxidant Primary Capsule: d alpha Tocopherol Beta Carotene Tocotrineol Grape Seed Oil

Secondary Capsule: Selenium

Vitamin C Ester

Category: Brain Support

Primary Capsule: d alpha Tocopherol DHA Omega 3

Lecithin Choline

Secondary Capsule:

Coenzyme Q 10 Ginkgo Biloba B 12 Category: Mood Support

Primary Capsule:

D alpha Tocopherol Lecithin

DHA Omega 3

Secondary Capsule:

SAME L Tyrosine

Category: Cardio Support

Primary Capsule: d alpha Tocopherol Tocotrienol

Flax Oil Omega 6 Fish Oil Omega 3

Secondary Capsule: Calcium Magnesium Coenzyme Q 10

Category: Diet Support

Primary Capsule:

Cojugated Linolic Acid Flax Seed Oil

Secondary Capsule:

Chromium

Zinc

L Carnitine

Category: Immune Support

Primary Capsule:

Garlic Oil

Olive Leaf Oil d alpha Tocopherol

Secondary Capsule:

Zinc Echinacea

Category: Laxative Support

Primary Capsule:

Aloe Vera Flax Seed Oil

Secondary Capsule:

Senna Leaf Psyllium

Category: Prostate Support Primary Capsule: Saw Palmetto Oil Pygeum Oil Flaxseed Oil Pumpkin Seed Oil

Secondary Capsule:

Selenium Zinc

Boswellia Senata

Category: Inflammation Support

Primary Capsule:

Boswellia Senata Oil Guggul Oil

Omega 3 Oil Ginger Oil

Secondary Capsule:

Curcumin Holy Basil

Category: Sports Nutrition / Muscle Support

Primary Capsule: Cojugated Linolic Acid

MCT Oil

Secondary Capsule: Zinc

Chromium

Tribulus Tenestris

19 Nor-5-Androstendione

Category: Menopause Support

Primary Capsule: Evening Primrose Oil Red Rasbeny Oil

Secondary Capsule:

Licorice Root Black Cohosh Soy Isoflavones Category: Cholesterol Support

Primary Capsule:

Sterol Esters Guggul Oil d alpha Tocopherol Tocotrienol

Secondary Capsule:

Garlic Extract Zinc

From the above discussion, it will be appreciated that the present invention provides novel integrated capsule delivery apparatus and methods for delivering diverse physical states (e.g., solid, liquid, gas or dispersion) of a single active ingredient or medicament (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof), or a plurality of active ingredients or medicaments, in a single dosage capsular form, wherein at least two of the active ingredients or medicaments if different receiving chambers have physical states that differ. In preferred design, the encapsulation processes and multi-compartment capsular technology of the present invention may include various desirable properties such as, for example, controlling time-release of key active ingredients or medicaments, prolonging shelf-life of the active ingredients or medicaments, improving palatabihty, reducing overall production costs and reducing the number of capsules consumed by a patient or consumer as nutritional or therapeutic agents. The present invention provides novel integrated capsule delivery apparatus and methods for delivering a single dosage, multi-compartment capsule comprising a capsular base and cap configuration, wherein the size and shape of the cap, relative to its sealing relationship with the base, generally eliminates or substantially reduces any potential dead space volume within the internal periphery of the capsule, thereby functionally negating the opportunity for reaction between an air bubble and one or more active ingredients introduced into the capsule and, accordingly, improving stability ofthe capsular ingredient(s).

The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative, and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

What is claimed and desired to be secured by United States Letters Patent is:

1. A multi-compartment capsule, comprising: a first receiving chamber comprising at least one ingredient having a first physical state, wherein said ingredient is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral; and a second receiving chamber comprising at least one ingredient having a second physical state, wherein said ingredient is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral; wherem said first physical state of said ingredient of said first receiving chamber being different from said second physical state of said ingredient of said second receiving chamber; and said ingredient of said first receiving chamber being different from said ingredient of said second receiving chamber.

2. A multi-compartment capsule as defined in claim 1, further comprising a base and a conesponding cap, wherein said cap is configured to provide a sealing relationship when engaging said base.

3. A multi-compartment capsule as defined in claim 2, wherein said cap comprises a configuration adapted to reduce dead volume space within said first receiving chamber.

4. A multi-compartment capsule as defined in claim 1, wherein said first receiving chamber comprises no dead volume space.

5. A multi-compartment capsule as defined in claim 1, wherein said physical state of said ingredient in said first receiving chamber is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

6. A multi-compartment capsule as defined in claim 5, wherem said solid is selected from the group consisting of a pill, a tablet, a capsule, a powder, granulation, flakes, a troche, a suppository, an ointment, a paste, an emulsion and a cream.

7. A multi-compartment capsule as defined in claim 5, wherein said liquid is selected from the group consisting of a solution, a spirit, an elixir, a spray, a syrup and a fluid exfract.

8. A multi-compartment capsule as defined in claim 5, wherein said dispersion is selected from the group consisting of an aerosol, a suspension, an emulsion, a foam, a solid foam and a gel.

9. A multi-compartment capsule as defined in claim 1, further comprising a third receiving chamber comprising at least one ingredient selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral.

10. A multi-compartment capsule, comprising: a primary capsule comprising at least one ingredient having a first physical state, wherein said ingredient is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral; and a secondary capsule comprising at least one ingredient having a second physical state, wherein said ingredient is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral; wherein said first physical state of said ingredient of said primary capsule being different from said second physical state of said ingredient of said secondary capsule; said ingredient of said primary capsule being different from said ingredient of said secondary capsule; and said primary capsule comprising an internal periphery sufficient for receiving said mgredient and said secondary capsule therein.

11. A multi-compartment capsule as defined in claim 10, wherein said primary capsule comprises no dead volume space.

12. A multi-compartment capsule as defined in claim 10, wherein said capsules are formed of a material selected from the group consisting of gelatin, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, canageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, oleoresin, polyvinylacetate, hydroxypropyl methyl cellulose, polymerisates of acrylic or methacrylic esters, polyvinylacetate-phtalate and combinations thereof.

13. A multi-compartment capsule as defined in claim 10, wherein at least one of said ingredients introduced in said capsules comprises a moisture content in the range of about 0% to 6% by weight.

14. A multi-compartment capsule, comprising: a capsule comprising a longitudinally extending body having a length; and at least one dividing wall formed along said length of said extending body, said dividing wall forming a first receiving chamber and a second receiving chamber; wherein said first receiving chamber comprising at least one ingredient having a first physical state, wherein said ingredient is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral; said second receiving chamber comprising at least one ingredient having a second physical state, wherein said ingredient is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral; said first physical state of said ingredient of said first receiving chamber being different from said second physical state of said ingredient of said second receiving chamber; and said ingredient of said first receiving chamber being different from said second ingredient of said second receiving chamber.

15. A multi-compartment capsule as defined in claim 14, further comprising a second dividing wall defining a third receiving chamber comprising at least one ingredient.

16. An encapsulation process for forming a multi-compartment capsule, said process comprising the steps of: providing a primary capsule having a base and a cap; providing a secondary capsule having a base and a cap; introducing at least one ingredient having a first physical state into said secondary capsule, wherein said ingredient introduced into said primary capsule is selected from the group consisting of a nufraceutical, a vitamin, a dietary supplement and a mineral; positioning said cap of said secondary capsule in sealing relationship with said base; introducing at least one ingredient having a second physical state into said primary capsule, wherein said ingredient infroduced into said primary capsule is selected from the group consisting of a nufraceutical, a vitamin, a dietary supplement and a mineral, wherein said first physical state of said ingredient of said secondary capsule is different from said second physical state of said ingredient of said primary capsule, and wherein said ingredient of said secondary capsule is different from said ingredient of said primary capsule; introducing said secondary capsule into said base of said primary capsule; and positioning said cap of said primary capsule in sealing relationship with said base.

17. An encapsulation process as defined in claim 16, further comprising the step of reducing dead volume space within said primary capsule.

18. An encapsulation process as defined in claim 16, further comprising the step of introducing a filling material into said cap of said primary capsule to reduce dead volume space.

19. An encapsulation process as defined in claim 16, wherein said cap of said primary capsule comprises a configuration sufficient for reducing dead volume space within the primary capsule.

20. An encapsulation process as defined in claim 16, wherein said physical state of said ingredient in said primary capsule is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

21. An encapsulation process as defined in claim 20, wherein said solid is selected from the group consisting of a pill, a tablet, a capsule, a powder, granulation, flakes, a troche, a suppository, an ointment, a paste, an emulsion and a cream.

22. An encapsulation process as defined in claim 20, wherein said liquid is selected from the group consisting of a solution, a spirit, an elixir, a spray, a syrup and a fluid extract.

23. An encapsulation process as defined in claim 20, wherein said dispersion is selected from the group consisting of an aerosol, a suspension, an emulsion, a foam, a solid foam and a gel.

24. An encapsulation process as defined in claim 16, wherein said ingredient introduced into said primary capsule is the same as said ingredient introduced into said secondary capsule.

25. An encapsulation process as defined in claim 16, further comprising the steps of: providing a tertiary capsule having a base and a cap; introducing at least one ingredient having a third physical state into said tertiary capsule; positioning said cap of said secondary capsule in sealing relationship with said base; and introducing said tertiary capsule into said base of said secondary capsule.

26. An encapsulation process as defined in claim 25, wherein said tertiary capsule comprises a time-release coating.

27. An encapsulation process as defined in claim 16, wherein said primary capsule is formed of a material selected from the group consisting of gelatin, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, canageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl methyl cellulose, oleoresin, polymerisates of acrylic or mthacrylic esters, polyvinylacetate-phtalate and combinations thereof.

28. An encapsulation process as defined in claim 25, wherein said primary capsule further comprises a soft elastic capsule formed of a material selected from the group consisting of glycerin and sorbitol.

29. An encapsulation process as defined in claim 28, wherein said soft elastic capsule includes an antimicrobial selected from the group consisting of paraben and sorbic acid.

30. An encapsulation process as defined in claim 16, wherein said ingredient infroduced in said primary capsule comprises a moisture content in the range of about 0% to

6% by weight.

31. An encapsulation process as defined in claim 30, wherein said ingredient primary capsule comprises a moisture content in the range of about 0% to 3% by weight

32. An encapsulation process as defined in claim 16, wherein said primary and secondary capsules contain at least one pharmaceutically acceptable lubricant in the range of about 0% to 10% by weight.

33. An encapsulation process as defined in claim 32, wherein said lubricant is selected from the group consisting of aluminiurnstearate, calciumstearate, magnesiumstearate, tinstearate, talc, sodium lauryl sulfate, lecithins, mineral oils, stearic acid, silicones and combinations thereof.

34. An encapsulation process for forming a multi-compartment capsule, said process comprising the steps of: providing a capsule comprising a cap, a base configured having a longitudinally extending body including a length and at least one dividing wall formed along said length of said extending body, said dividing wall adapted to form a first receiving chamber and a second receiving chamber; introducing at least one ingredient having a first physical state into said second receiving chamber, wherein said ingredient introduced into said primary capsule is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral; introducing at least one ingredient having a second physical state into said first receiving chamber, wherein said ingredient infroduced into said primary capsule is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral, wherein said first physical state of said ingredient of said second receiving chamber is different from said second physical state of said ingredient of said first receiving chamber, and wherein said said ingredient of said second receiving chamber is different from said said ingredient of said first receiving chamber; and positioning said cap in sealing relationship with said base.

35. An encapsulation process as defined in claim 34, further comprising the step of reducing dead volume space within said primary capsule.

36. A multi-compartment capsule, comprising: a first receiving chamber comprising at least one ingredient having a first physical state; and a second receiving chamber comprising at least one ingredient having a second physical state, wherein said first physical state of said ingredient of said first receiving chamber is different from said second physical state of said ingredient of said second receiving chamber, and wherein said ingredient of said first receiving chamber is different from said ingredient of said second receiving chamber.

37. A multi-compartment capsule as defined in claim 36, wherein said first receiving chamber comprises no dead space.

38. A multi-compartment capsule as defined in claim 36, further comprising a base and a conesponding cap, wherein said cap is configured to provide a sealing relationship when engaging said base.

39. A multi-compartment capsule as defined in claim 38, wherein said cap is configured to reduce dead volume space within said first receiving chamber.

40. A multi-compartment capsule as defined in claim 38, further comprising a filling material introduced into said cap to reduce dead volume space within said first receiving chamber.

41. A multi-compartment capsule as defined in claim 36, wherein said ingredient in said first receiving chamber is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

42. A multi-compartment capsule as defined in claim 41, wherein said ingredient in said second receiving chamber is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

43. A multi-compartment capsule as defined in claim 36, wherem said ingredient in said first receiving chamber comprises a pharmaceutical and said ingredient in said second receiving chamber comprises a pharmaceutical.

44. A multi-compartment capsule as defined in claim 36, wherein said ingredient in said first receiving chamber comprises a pharmaceutical and said ingredient in said second receiving chamber is selected from the group consisting of a biotechnical, a nufraceutical, a vitamin, a dietary supplement and a mineral.

45. A multi-compartment capsule as defined in claim 36, wherein said physical state of said ingredient in said first receiving chamber is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

46. A multi-compartment capsule as defined in claim 45, wherein said solid is selected from the group consisting of a pill, a tablet, a capsule, a powder, granulation, flakes, a troche, a suppository, an ointment, a paste, an emulsion and a cream.

47. A multi-compartment capsule as defined in claim 45, wherein said liquid is selected from the group consisting of a solution, a spirit, an elixir, a spray, a syrup and a fluid extract.

48. A multi-compartment capsule as defined in claim 45, wherein said dispersion is selected from the group consisting of an aerosol, a suspension, an emulsion, a foam, a solid foam and a gel.

49. A multi-compartment capsule as defined in claim 36, wherein at least one of said receiving chambers comprises a time-release coating.

50. A multi-compartment capsule as defined in claim 36, further comprising a third receiving chamber comprising at least one ingredient.

51. A multi-compartment capsule as defined in claim 50, wherein said ingredient in said third receiving chamber is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

52. A multi-compartment capsule as defined in claim 51, wherein said ingredient in said third receiving chamber is different than the ingredients in said first and said second receiving chamber.

53. A multi-compartment capsule as defined in claim 51 or 52, wherein said ingredient in said third receiving chamber is at a different physical state from the physical states of the ingredients in said first and said second receiving chamber.

54. A multi-compartment capsule, comprising: a primary capsule comprising at least one ingredient having a first physical state; a secondary capsule comprising at least one ingredient having a second physical state; said first physical state of said ingredient of said primary capsule being different from said second physical state of said ingredient of said secondary capsule; said ingredient of said primary capsule being different from said ingredient of said secondary capsule; and said primary capsule comprising an internal periphery sufficient for receiving said ingredient and said secondary capsule therein.

55. A multi-compartment capsule as defined in claim 54, wherein said primary capsule further comprises a base and a conesponding cap, wherein said cap is configured to provide a sealing relationship when engaging said base.

56. A multi-compartment capsule as defined in claim 54, wherein said primary capsule comprises no dead volume space.

57. A multi-compartment capsule, comprising: a capsule comprising a longitudinally extending body having a length; at least one dividing wall formed along said length of said extending body, said dividing wall forming a first receiving chamber and a second receiving chamber; said first receiving chamber comprising at least one ingredient having a first physical state; said second receiving chamber comprising at least one ingredient having a second physical state; said first physical state of said ingredient of said first receiving chamber being different from said second physical state of said ingredient of said second receiving chamber; said ingredient of said first receiving chamber being different from said ingredient of said second receiving chamber.

58. A multi-compartment capsule as defined in claim 57, wherein said capsule further comprises a base and a conesponding cap, wherein said cap is configured to provide a sealing relationship when engaging said base.

59. A multi-compartment capsule as defined in claim 57, wherein said ingredients are selected from the group consisting of a pharmaceutical, a biotechnical, a nufraceutical, a vitamin, a dietary supplement and a mineral.

60. An encapsulation process for forming a multi-compartment capsule, said process comprising the steps of: providing a primary capsule having a base and a cap; providing a secondary capsule having a base and a cap; introducing at least one ingredient having a first physical state into said secondary capsule; positioning said cap of said secondary capsule in sealing relationship with said base; introducing at least one ingredient having a second physical state into said primary capsule, wherein said first physical state of said ingredient of said secondary capsule is different from said second physical state of said ingredient of said primary capsule, and wherein said ingredient of said secondary capsule is different from said ingredient of said primary capsule; introducing said secondary capsule into said base of said primary capsule; and positioning said cap of said primary capsule in sealing relationship with said base.

61. An encapsulation process as defined in claim 60, further comprising the step of reducing dead volume space within said primary capsule.

62. An encapsulation process as defined in claim 60, further comprising the step of adding a filler material into at least one of said capsules selected from the group consisting of gelatin, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, canageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl methyl cellulose, oleoresin, polyvinylacetate-phtalate, polymerisates of acrylic or methacrylic esters and combinations thereof.

63. An encapsulation process as defined in claim 60, wherein at least one cap of said capsuels comprises a configuration sufficient for reducing dead volume space within the primary capsule.

64. An encapsulation process as defined in claim 60, wherein said ingredient infroduced into said primary and secondary capsules is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

65. An encapsulation process as defined in claim 60, wherein said physical state of said ingredient in said primary capsule is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

66. An encapsulation process as defined in claim 65, wherem said solid is selected from the group consisting of a pill, a tablet, a capsule, a powder, granulation, flakes, a troche, a suppository, an ointment, a paste, an emulsion and a cream.

67. An encapsulation process as defined in claim 65, wherein said liquid is selected from the group consisting of a solution, a spirit, an elixir, a spray, a syrup and a fluid exfract.

68. An encapsulation process as defined in claim 65, wherein said dispersion is selected from the group consisting of an aerosol, a suspension, an emulsion, a foam, a solid foam and a gel.

69. An encapsulation process as defined in claim 60, wherein said ingredient in said primary capsule comprises a pharmaceutical and said ingredient in said secondary capsule is selected from the group consisting of a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

70. An encapsulation process as defined in claim 60, wherein said ingredient infroduced into said primary capsule and said secondary capsule is a pharmaceutical.

71. An encapsulation process as defined in claim 1, wherein at least one of said capsules comprises a time-release coating.

72. An encapsulation process as defined in claim 60, further comprising the steps of: providing a tertiary capsule having a base and a cap; introducing at least one ingredient having a third physical state into said tertiary capsule; positioning said cap of said secondary capsule in sealing relationship with said base; and introducing said tertiary capsule into said base of said secondary capsule.

73. An encapsulation process as defined in claim 72, wherein said ingredient in said tertiary capsule is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

74. An encapsulation process as defined in claim 73, wherein said ingredient in said tertiary capsule is different from the other ingredients ofthe other capsules.

75. An encapsulation process as defined in claim 73 or 74, wherem the ingredients are pharmaceuticals.

76. An encapsulation process as defined in claim 72, wherein said tertiary capsule comprises a time-release coating.

77. An encapsulation process as defined in claim 60 or claim 72, wherein at least one of said capsules further comprise a soft elastic capsule formed of a material selected from the group consisting of glycerin and sorbitol.

78. An encapsulation process as defined in claim 77, wherein said soft elastic capsule includes an antimicrobial selected from the group consisting of paraben and sorbic acid.

79. An encapsulation process as defined in claim 60, wherein said ingredient infroduced in said primary capsule comprises a moisture content in the range of about 0% to 6% by weight.

80. An encapsulation process as defined in claim 60, wherein said primary and secondary capsules contain at least one pharmaceutically acceptable lubricant in the range of about 0% to 10% by weight.

81. An encapsulation process as defined in claim 80, wherein said lubricant is selected from the group consisting of aluminiumstearate, calciumstearate, magnesiumstearate, tinstearate, talc, sodium lauryl sulfate, lecithins, mineral oils, stearic acid, silicones and combinations thereof.

82. An encapsulation process for forming a multi-compartment capsule, said process comprising the steps of: providing a capsule comprising a cap, a base configured having a longitudinally extending body including a length and at least one dividing wall formed along said length of said extending body, said dividing wall adapted to form a first receiving chamber and a second receiving chamber; introducing at least one ingredient having a first physical state into said second receiving chamber; introducing at least one ingredient having a second physical state into said first receiving chamber, wherein said first physical state of said ingredient of said second receiving chamber being different from said second physical state of said ingredient of said first receiving chamber, and wherein said ingredient of said second receiving chamber is different from said ingredient of said first receiving chamber; and positioning said cap in sealing relationship with said base.

83. An encapsulation process as defined in claim 82, further comprising the step of reducing dead volume space within said primary capsule.

84. An encapsulation process as defined in claim 82, wherein said cap comprises a configuration sufficient for reducing dead volume space within said capsule.

85. An encapsulation process as defined in claim 82, wherein said ingredient in said first receiving chamber is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

86. An encapsulation process as defined in claim 82, wherein said physical state of said ingredient in said receiving chamber is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

87. An encapsulation process as defined in claim 86, wherein said solid is selected from the group consisting of a pill, a tablet, a capsule, a powder, granulation, flakes, a froche, a suppository, an ointment, a paste, an emulsion and a cream.

88. An encapsulation process as defined in claim 86, wherein said liquid is selected from the group consisting of a solution, a spirit, an elixir, a spray, a syrup and a fluid extract.

89. An encapsulation process as defined in claim 86, wherein said dispersion is selected from the group consisting of an aerosol, a suspension, an emulsion, a foam, a solid foam and a gel.

90. An encapsulation process as defined in claim 82, wherein said ingredient in said second receiving chamber is selected from the group consisting of a pharmaceutical, a biotechnical, a nufraceutical, a vitamin, a dietary supplement and a mineral.

91. An encapsulation process as defined in claim 82, wherein said physical state of said ingredient in said second receiving chamber is selected from the group consisting of a solid, a liquid, a gas and a dispersion.

92. An encapsulation process as defined in claim 91, wherein said solid is selected from the group consisting of a pill, a tablet, a capsule, a powder, granulation, flakes, a troche, a suppository, an ointment, a paste, an emulsion and a cream.

93. An encapsulation process as defined in claim 91, wherein said liquid is selected from the group consisting of a solution, a spirit, an elixir, a spray, a syrup and a fluid extract.

94. An encapsulation process as defined in claim 91, wherein said dispersion is selected from the group consisting of an aerosol, a suspension, an emulsion, a foam, a solid foam and a gel.

95. An encapsulation process as defined in claim 82, wherein said ingredient in said first receiving chamber comprises a pharmaceutical and said ingredient in said second receiving chamber is selected from the group consisting of a pharmaceutical.

96. An encapsulation process as defined in claim 82, wherein said ingredient in said first receiving chamber comprises a pharmaceutical and said ingredient in said second receiving chamber is selected from the group consisting of a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

97. An encapsulation process as defined in claim 82, wherein said ingredient in said first receiving chamber comprises a pharmaceutical and said ingredient in said second receiving chamber is also a pharmaceutical.

98. An encapsulation process as defined in claim 82, wherein said first receiving chamber comprises a time-release coating.

99. An encapsulation process as defined in claim 82 or 98, wherein said second receiving chamber comprises a time-release coating.

100. An encapsulation process as defined in claim 82, further comprising the steps of: positioning a second dividing wall along said length of said extending body of said base, said second dividing wall adapted to form a third receiving chamber; and introducing at least one ingredient having a physical state into said third receiving chamber.

101. An encapsulation process as defined in claim 100, wherein said ingredient infroduced into said third receiving chamber is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

102. An encapsulation process as defined in claim 100, wherem said ingredient introduced into said third receiving chamber is a pharmaceutical.

103. An encapsulation process as defined in claim 100 or 102, wherein all of the ingredients are pharmaceuticals.

104. An encapsulation process as defined in claim 82, 100 or 103, wherein said primary and secondary capsules contain at least one pharmaceutically acceptable lubricant in the range of about 0% to 10% by weight.

105. An encapsulation process as defined in claim 104, wherein said lubricant is selected from the group consisting of aluminiumstearate, calciumstearate, magnesiumstearate, tinstearate, talc, sodium lauryl sulfate, lecithins, mineral oils, stearic acid, silicones and combinations thereof.

106. A multi-compartment capsule according to claim 1, wherein the first receiving chamber contains Glucosamine/Chondroitin and the second receiving chamber contains

Vitamin E.

107. A multi-compartment capsule according to claim 106, wherein the Glucosamine/Chondroitin is in a solid physical state and the Vitamin E is in a liquid physical state.

108. A multi-compartment capsule according to claim 1, wherein the first receiving chamber contains S-adenosylmethione (SAMe) and the second receiving chamber contains Vitamin E.

109. A multi-compartment capsule according to claim 108, wherein the S-adenosylmethione (SAMe) is in a solid physical state and the Vitamin E is in a liquid physical state.

110. A multi-compartment capsule according to claim 1, wherein the first receiving chamber contains Curcumin, Holy Basil, Zinc and the second receiving chamber contains Omega 3 Fatty Acids DHA & EPA.

111. A multi-compartment capsule according to claim 110, wherein the Curcumin,

Holy Basil, Zinc is in a solid physical state and the Omega 3 Fatty Acids DHA & EPA is in a liquid physical state.

112. A multi-compartment capsule according to claim 1, wherein the first receiving chamber contains Vitamin C and the second receiving chamber contains Vitamin E.

113. A multi-compartment capsule according to claim 36, wherein the first receiving chamber contains Fluoxetine and the second receiving chamber contains Vitamin E.

114. A multi-compartment capsule according to claim 36, wherein the first receiving chamber contains Rofecoxib and the second receiving chamber contains Vitamin E.

115. A multi-compartment capsule according to claim 36, wherein the first receiving chamber contains Diphenhydramine Hydrochloride and the second receiving chamber contains Vitamin E.

116. A multi-compartment capsule according to claim 36, wherein the first receiving chamber contains Celecoxib and the second receiving chamber contains Ibuprofen.

117. A multi-compartment capsule according to claim 116, wherein the Celecoxib is in a solid physical state and the ibuprofen is in a liquid physical state.

118. A multi-compartment capsule according to claim 50, wherein the first capsul contains Fluoxetine, the second capsule contains S-adenosylmethione, and the third receiving capsule contains Vitamin E.