WO2003086267A2 - Systeme capsulaire a plusieurs compartiments et plusieurs phases - Google Patents

Systeme capsulaire a plusieurs compartiments et plusieurs phases Download PDF

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Publication number
WO2003086267A2
WO2003086267A2 PCT/US2003/010816 US0310816W WO03086267A2 WO 2003086267 A2 WO2003086267 A2 WO 2003086267A2 US 0310816 W US0310816 W US 0310816W WO 03086267 A2 WO03086267 A2 WO 03086267A2
Authority
WO
WIPO (PCT)
Prior art keywords
capsule
ingredient
receiving chamber
physical state
encapsulation process
Prior art date
Application number
PCT/US2003/010816
Other languages
English (en)
Other versions
WO2003086267B1 (fr
WO2003086267A3 (fr
Inventor
Fred H. Miller
Original Assignee
Miller Fred H
Ausec Lance R
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US10/369,247 external-priority patent/US20030194430A1/en
Priority to EP03717010A priority Critical patent/EP1499303A4/fr
Priority to AU2003220689A priority patent/AU2003220689A1/en
Priority to JP2003583294A priority patent/JP2005528383A/ja
Priority to CA2481486A priority patent/CA2481486C/fr
Priority to NZ536267A priority patent/NZ536267A/en
Application filed by Miller Fred H, Ausec Lance R filed Critical Miller Fred H
Publication of WO2003086267A2 publication Critical patent/WO2003086267A2/fr
Publication of WO2003086267A3 publication Critical patent/WO2003086267A3/fr
Priority to US10/804,576 priority patent/US7670612B2/en
Publication of WO2003086267B1 publication Critical patent/WO2003086267B1/fr
Priority to US12/689,669 priority patent/US8361497B2/en
Priority to US13/746,743 priority patent/US20130136791A1/en
Priority to US14/036,521 priority patent/US9241911B2/en
Priority to US15/005,508 priority patent/US9539216B2/en

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C39/00—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
    • B29C39/02—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • B29C39/10—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor for making articles of definite length, i.e. discrete articles incorporating preformed parts or layers, e.g. casting around inserts or for coating articles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4833—Encapsulating processes; Filling of capsules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/0058—Liquid or visquous
    • B29K2105/0061—Gel or sol

Definitions

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • hard gelatin capsules may be manufactured by dipping plates of
  • 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.
  • 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.
  • a polyol such as glycerin or sorbitol.
  • 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.
  • sugar-coating, a precursor to film-coating
  • 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.
  • 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.
  • 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.
  • delivery vehicle e.g., tablet or capsule
  • 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.
  • 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.
  • delivery vehicles e.g., tablets and capsules
  • Mixtures of waxes, cellulose, silicone and similar resins have been found useful by those skilled in the art for creating-sustained release coatings.
  • these prior art coatings function to delay the release of the active ingredient or medicament to the targeted body system, thereby facilitating a timed, abso ⁇ tion rate in the body.
  • 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.
  • 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.
  • the prior art contemplates a hard capsule formulation which contains three different compartments of active medicaments for administration to the vaginal and rectal areas.
  • 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.
  • 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.
  • 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.
  • 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.
  • multi-compartmental capsules 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 viable direct-fed microbial i.e., gastrointestinal microorganisms, including bacteria, live cell yeasts, fungi or a combination thereof
  • 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.
  • 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.
  • active ingredients or medicaments may take the physical form of a solid (e.g.
  • 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)).
  • 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.
  • 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.
  • 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.
  • 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.
  • the active ingredient may adversely react with a co-administered drug, for example a less bioavailable solid or semi-solid, in a physiological environment.
  • a co-administered drug for example a less bioavailable solid or semi-solid
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a plurality of 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).
  • 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.
  • synergism 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.
  • 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.
  • 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).
  • 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.
  • diverse physical states e.g., solid, liquid, gas or dispersion
  • active ingredients or medicaments e.g., pharmaeceutical, biotechical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof
  • active ingredients or medicaments e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof
  • active ingredients or medicaments e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof
  • active ingredients or medicaments e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin
  • active ingredients or medicaments e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof
  • 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.
  • 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.
  • active ingredients or medicaments e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof
  • a physical state i.e., solid, liquid, gas or dispersion
  • a multi-compartment capsule comprising a base, a corresponding cap and one or more dividing walls positionable between the base and the cap.
  • 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.
  • 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.
  • 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
  • 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.
  • active ingredients or medicaments e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 abso ⁇ tion of those active ingredients introduced into the different receiving chambers of the multi-compartment capsule to release at different release rates.
  • 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.
  • 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.
  • 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.
  • 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.
  • encapsulation may be used to deliver their respective contents, including but not limited to, dissolution, melting, ablation or biodegradation of the encapsulating wall.
  • the medicaments retained in the multicompartment capsule may actually diffuse through one or more of the encapsulating walls.
  • 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.
  • 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.
  • a multi-compartment capsule as defined above, wherein said cap comprises a configuration adapted to reduce dead volume space within said first receiving chamber.
  • 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.
  • 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.
  • said first receiving chamber comprises no dead volume space.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a multi-compartment capsule as defined above, wherein said first receiving chamber comprises a time-release coating.
  • a multi-compartment capsule as defined above, further comprising a third receiving chamber comprising at least one ingredient.
  • said ingredient in said third receiving chamber is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a multi-compartment capsule as defined above, wherein said primary capsule comprises a time-release coating.
  • 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.
  • 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
  • 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.
  • said soft elastic capsule includes an antimicrobial selected from the group consisting of paraben and sorbic acid.
  • 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.
  • 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
  • said ingredient introduced in said primary capsule comprises a moisture content in the range of about 0% to 6% by weight.
  • said ingredient introduced in said secondary capsule comprises a moisture content in the range of about 0% to 6% by weight.
  • 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.
  • 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.
  • a multi-compartment capsule as defined above, wherein said primary capsule is formed having a first color.
  • 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.
  • said base and said cap are formed having different colors.
  • 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.
  • 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.
  • a multi-compartment capsule as defined above, wherein said capsule comprises a time-release coating.
  • a multi-compartment capsule as defined above, wherein said dividing wall comprises a time-release coating.
  • 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.
  • said capsule further comprises a soft elastic capsule formed of a material selected from the group consisting of glycerin and sorbitol.
  • 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.
  • 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
  • said ingredient introduced in said first receiving chamber comprises a moisture content in the range of about 0% to 6% by weight.
  • said ingredient introduced in said second receiving chamber comprises a moisture content in the range of about 0% to 6% by weight.
  • 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.
  • an encapsulation process for forming a multi-compartment capsule 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.
  • an encapsulation process as defined above further comprising the step of reducing dead volume space within said primary capsule.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • said ingredient in said tertiary capsule is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral.
  • 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.
  • 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.
  • 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 mthacryl
  • said primary capsule further comprises a soft elastic capsule formed of a material selected from the group consisting of glycerin and sorbitol.
  • 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.
  • said secondary capsule further comprises a soft elastic capsule formed of a material selected from the group consisting of glycerin and sorbitol.
  • said ingredient introduced in said primary capsule comprises a moisture content in the range of about 0% to 6% by weight.
  • said ingredient introduced in said secondary capsule comprises a moisture content in the range of about 0% to 6% by weight.
  • 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.
  • 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.
  • 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.
  • 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.
  • said ingredient in said third receiving chamber is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral.
  • 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.
  • said dispersion is selected from the group consisting of an aerosol, a suspension, an emulsion, a foam, a solid foam and a gel.
  • 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.
  • 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 m
  • said capsule further comprises a soft elastic capsule formed of a material selected from the group consisting of glycerin and sorbitol.
  • 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.
  • 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.
  • said capsule may comprise a multi-compartment capsule.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • said ingredient introduced in said secondary capsule comprises a moisture content in the range of about 0% to 6% by weight.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a multi-compartment capsule as defined above, wherein said capsule comprises a time-release coating.
  • 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.
  • 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, ole
  • 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.
  • 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.
  • an encapsulation process for forming a multi-compartment capsule 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.
  • an encapsulation process as defined above, further comprising the step of reducing dead volume space within said primary capsule.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • said ingredient introduced into said primary capsule is the same as said ingredient introduced into said secondary capsule.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • encapsulation process as defined above, further comprising the step of reducing dead volume space within said primary capsule.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • said second dividing wall comprises a time-release coating.
  • said capsule further comprises a soft elastic capsule formed of a material selected from the group consisting of glycerin and sorbitol.
  • 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.
  • 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;
  • FIG. 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
  • FIG. 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
  • 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 peripher
  • 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;
  • 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.
  • 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.
  • a multi-compartment capsule 10 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.
  • 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)
  • 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.
  • 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.
  • a multi-compartment capsule 110 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).
  • 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
  • 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.
  • 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.
  • 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
  • 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.
  • 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).
  • 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.
  • a physical state e.g., solid, liquid, gas or dispersion
  • FIG. 1 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.
  • 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.
  • active ingredients or medicaments e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof
  • the dividing wall 216 seats within the internal periphery of both the base 214 and the conesponding cap 212.
  • one or more active ingredients or medicaments e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • active ingredients or medicaments e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof
  • 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.
  • a physical state e.g., solid, liquid, gas or dispersion
  • 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
  • a secondary capsule 320 may be selectively introduced into at least a portion of the internal periphery of the receiving chamber 318d.
  • 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 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
  • 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.
  • a physical state e.g., solid, liquid, gas or dispersion
  • FIG. 7 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.
  • 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.
  • 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.
  • active ingredients or medicaments e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof
  • one presently prefened embodiment of an encapsulation process 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)
  • 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.
  • 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
  • a liquid may be selectively infroduced into at least a portion ofthe internal periphery ofthe receiving chamber 418e.
  • 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.
  • a physical state e.g., solid, liquid, gas or dispersion
  • 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.
  • 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.
  • 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.
  • 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.
  • active ingredients or medicaments e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof
  • a first physical state e.g., solid, liquid, gas or dispersion
  • 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.
  • active ingredients or medicaments e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof
  • a second physical state e.g., solid, liquid, gas or dispersion
  • 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.
  • 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.
  • One presently prefened embodiment of an encapsulation process 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
  • active ingredients or medicaments e.g., pharmaec
  • 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
  • a liquid may be selectively introduced into at least a portion of the internal periphery of the receiving chamber 518e.
  • 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.
  • a physical state e.g., solid, liquid, gas or dispersion
  • FIG. 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.
  • active ingredients or medicaments e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof
  • 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.
  • 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.
  • 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.
  • active ingredients or medicaments e.g., pharmaeceutical, biotechnical, nufraceutical, vitamin, dietary supplement, mineral or combination thereof
  • One presently prefened embodiment of an encapsulation process 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
  • 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
  • a liquid may be selectively introduced into at least a portion ofthe internal periphery of the receiving chamber 628e of the secondary capsule 620.
  • a gas may be introduced into at least a portion of the internal periphery of the receiving chamber 618 ofthe primary capsule 611.
  • the ingredient(s) introduced into one of the receiving chambers 618, 628 of the primary and secondary capsules 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.
  • a multi-compartment capsule of the present invention 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.
  • active ingredients or medicaments e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof
  • 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.
  • 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.
  • 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 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
  • 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.
  • 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.
  • a multi-compartment capsule 810 of the present invention 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.
  • 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.
  • active ingredients or medicaments e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof
  • 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.
  • 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.
  • a hydrophilic polymer such as gelatin.
  • 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.
  • 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.
  • an inert compound for example, nitrogen gas
  • 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.
  • 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.
  • one presently prefened embodiment of an encapsulation process 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
  • 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.
  • 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.
  • a multi-compartment capsule 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.
  • active ingredients or medicaments e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, dietary supplement, mineral or combination thereof
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a hydrophilic polymer such as gelatin.
  • 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.
  • 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.
  • an inert compound for example, nitrogen gas
  • 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.
  • 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.
  • one presently prefened embodiment of an encapsulation process 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.
  • active ingredients or medicaments e.g., pharmaeceutical, biotechn
  • 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.
  • 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).
  • 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).
  • 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.
  • 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 may include, for example, LICAPS® capsules (for poorly soluble compounds), VCAPSTM 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.
  • the primary capsule may be kept under conditions of low humidity within a filling machine during the contemplated steps of rectifying and assembling.
  • the primary capsule may contain moisture content in the range of approximately 0% to 6% of the total weight.
  • 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.
  • a moisture content of approximately 0% to 3% by weight is preferable.
  • capsules having a higher moisture content than those stated herein are certainly not outside the spirit and scope ofthe present invention.
  • the shape of the base and conesponding cap of the capsules e.g., primary, secondary, tertiary, etc.
  • the shape of the base and conesponding cap of the 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.
  • 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.
  • 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.
  • the perimeter of the dividing wall preferably engages the inner capsular walls of the capsule to provide a sealing relationship therebetween.
  • 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.
  • 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.
  • 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.
  • 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 abso ⁇ tion of those active ingredients infroduced into the different receiving chambers ofthe multi-compartment capsule to release at different release rates.
  • 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.
  • 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 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 pu ⁇ ose being to facilitate the release ofthe active ingredients at different release rates.
  • the inco ⁇ oration 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.
  • all ofthe active ingredients may be microencapsulated.
  • only selected ingredients may be microencapsulated for delayed release, while other ingredients may be provided for immediate abso ⁇ tion.
  • the inco ⁇ oration 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.
  • 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).
  • phases i.e., solid phase, liquid phase, gas phase or dispersion phase.
  • 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.
  • liquid is defined as including, by way of example only and not by way of limitation, solutions, spirits, elixirs, sprays, syrups or fluid extracts.
  • dispenser 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.
  • 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.
  • biotechnical is defined as any substance that is derived from a biotechnology process.
  • Biotechnology 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.
  • 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.
  • 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).
  • pharmaeceutical properties e.g., poor water solubility, pH lability, physical incompatibility, chemical incompatibility, macromolecular size and the like
  • proteins e.g., hormones, erythropoeitms, colony stimulating factors, interferons, interleukins, plasminogen activators, monoclonal antibodies, vaccines, plant proteins, such as soy and other therapeutic proteins
  • 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.
  • co-morbidities a term often shortened and referred to as "co-morbid.”
  • 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.
  • 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.
  • D-glucuronic acid and D-acetylgalactosamine 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.
  • 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.
  • 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.
  • therapeutically effective amounts of glucosamine, chondroitin, and vitamin E 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.
  • a capsular format ofthe present invention may include the following composition:
  • the inco ⁇ oration 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.
  • the inco ⁇ oration 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.
  • 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.
  • 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.
  • SAMe S-adenosylmethione
  • methionine a sulfur-containing amino acid
  • ATP adenosine triphosphate
  • 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.
  • 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.
  • SAMe comprises a physical state (e.g., solid, liquid, gas or dispersion) different from the physical state of vitamin E.
  • 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.
  • 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:
  • the inco ⁇ oration 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.
  • the inco ⁇ oration 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 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.
  • therapeutically effective amounts of SAMe and vitamin E 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.
  • SAMe comprises a physical state (e.g., solid, liquid, gas or dispersion) different from the physical state of vitamin E.
  • 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.
  • 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. ⁇
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • EPA eicosapentaenoic acid
  • DHA docosahexaenoic acid
  • 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.
  • therapeutically effective amounts of curcumin, Holy Basil, zinc and fish oil 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.
  • 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.
  • 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
  • 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.
  • a capsular format of the present invention may include the following composition:
  • the inco ⁇ oration of time-release coatings to varying the release rates of the active ingredients may be used to target key time intervals or events when the body may be most able to utilize the named active ingredients.
  • the inco ⁇ oration 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 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
  • 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.
  • 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.
  • 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 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 pu ⁇ oses, but far larger quantities may be required to have an effect on halting or reversing cancer and heart disease.
  • 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.
  • therapeutically effective amounts of vitamin C and vitamin E 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.
  • a 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:
  • the inco ⁇ oration 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.
  • the inco ⁇ oration 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.
  • 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.
  • therapeutically effective amounts of selenium, vitamin C, beta-carotene, vitamin E and fish oil 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).
  • a physical state e.g., solid, liquid, gas or dispersion
  • 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.
  • vitamin E, beta-carotene and fish oil omega 3 fatty acids DHA & EPA
  • 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:
  • the inco ⁇ oration of time-release coatings to varying the release rates of the active ingredients may be used to target key time intervals or events when the body may be most able to utilize the named active ingredients.
  • the inco ⁇ oration 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.
  • 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.
  • 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®).
  • SSRI's selective serotonin re-uptake inhibitors
  • This class may include, for example: fluoxetine (PROZAC®), sertraline (ZOLOFT®), paroxetine (PAXIL ®), fluvoxamine (LUVOX®), citalopram (CELEXA®) and escitalopram (LEXAPRO®).
  • fluoxetine PROZAC®
  • ZOLOFT® paroxetine
  • PAXIL ® paroxetine
  • LUVOX® fluvoxamine
  • CELEXA®
  • 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).
  • HCI hydrochloride salt
  • SAMe S-adenosylmethione
  • methionine a sulfttr-containing amino acid
  • ATP adenosine triphosphate
  • 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
  • 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.
  • IU international units
  • therapeutically effective amounts of Fluoxetine, SAMe and Vitamin E 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.
  • 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.
  • a capsular format of the present invention may include the following composition:
  • the inco ⁇ oration 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.
  • the inco ⁇ oration 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 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.
  • therapeutically effective amounts of Fluoxetine and SAMe and Vitamin E 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • NSAIDs non-steroidal anti-inflammatory drugs
  • 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®).
  • VIOXX® rofecoxib
  • CELEBREX® celecoxib
  • BEXTRA® valdecoxib
  • MOBIC® meloxicam
  • 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
  • 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.
  • therapeutically effective amounts of Rofecoxib and Vitamin E 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.
  • Rofecoxib comprises a physical state (e.g., solid, liquid, gas or dispersion) different from the physical state of Vitamin E.
  • 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.
  • a capsular format ofthe present invention may include the following composition:
  • the inco ⁇ oration 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.
  • the inco ⁇ oration 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 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.
  • therapeutically effective amounts of Rofecoxib and Vitamin E 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • ethanolamine division may include, for example: diphenhydramine, clemastine, dimenhydrinate, and doxylamine.
  • 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
  • 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.
  • therapeutically effective amounts of Diphenhydramine and Vitamin E 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.
  • physical states e.g., solid, liquid, gas or dispersion
  • 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:
  • the inco ⁇ oration 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.
  • the inco ⁇ oration 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.
  • 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.
  • 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.
  • 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® celecoxib
  • BEXTRA® valdecoxib
  • LODINE® etodolac
  • MOBIC® meloxicam
  • 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.
  • FDA United States Food and Drug Administration
  • 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®).
  • MOTRIN® ibuprofen
  • NAPROSYN® naproxen
  • VOLTAREN® diclofenac
  • flurbiprofen ANSAID®
  • indomethacin INDOCIN®
  • ketoprofen ORUDIS®
  • ketorolac TORADOL®
  • nabumetone RELAFEN®
  • oxaprozin DAYPRO
  • therapeutically effective amounts of Celecoxib and Ibuprofen 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.
  • 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.
  • a capsular format ofthe present invention may include the following composition:
  • the inco ⁇ oration 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.
  • the inco ⁇ oration 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 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.
  • therapeutically effective amounts of Celecoxib and Ibuprofen 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.
  • 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.
  • 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.
  • 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.
  • Acerola Extracts Alfalfa
  • Ginseng (American) Ginseng (Panax)
  • Damiana Extract 4 1 Damiana Leaves Powder
  • Dong Quai Extract 4 1 Dong Quai Root Powder
  • Fenugreek Extract 4 1
  • Fenugreek Extract 6 1
  • Ginkgo Extract 24/7%. Ginkgo Leaf Exfract 4:1
  • Grape Seed Extract 20 1
  • Grape Seed Extract 4 1
  • Grape Skin Extract 4 1 Grass-Leaved Sweetflai Extract
  • Hawthorne Beny Extract 4 1 Hawthorne Beny Powder
  • Horehound Extract 4 1 Horehound Herb Powder
  • Horse Chestnut Extract 20% Horse Chestnut Extract 4:1
  • Marigold Extract (Lutein 5%) Methozyisoflavone 99%
  • Muira Puama Extract 4 1 Muira Puama Powder
  • Oroxylum h dicum Extract 4 1 Oroxylum fridicum Powder
  • Peppermint Extract 4 1 Peppermint Powder
  • Polygala Tenoifolia Extract 4 1 Polygonum Extract
  • Polygonum Extract 4 1 Pregnenolone 99%
  • Schizandra Extract 4 1 Scopolia Acutangula Powder
  • Tribulus Extract 40% Tribulus Powder
  • HMB Hydromethyl Methyl Butyrate
  • Immxmoglobulin Hnmime System Support
  • 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 )
  • Vitamin D Vitamin E
  • 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.
  • Acetylcholinesterase Inhibitors Acetylcholinesterase Inhibitors ("Reversible") edrophonium (Tensilon) neostigmine (Prostigmin) physostigmine (Antilirium) Acetylcholinesterase Inhibitors ("Irreversible")
  • 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 (No ⁇ ace) esmolol (Brevibloc) sotalol (Batty) Hypolipidemic medicaments
  • HMG CoA Reductase Inhibitors atorvastatin (Lipitor) cerivistatin (Baycol) lovastatin (Mevacor) pravastatin (Pravochol) simvastatin (Zocor) Bile-acid sequestrants cholestyramine (Questran) colestipol (Colestid)
  • 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) ver
  • 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
  • COLD Chronic Obstructive Lung Disease
  • COPD Chronic Obstructive Pulmonary Disease
  • ARDS Acute Respiratory Distress Syndrome
  • 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)
  • GFD Gastro-esophageal Reflux Disease
  • 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 5HT 3 receptor antagonists dolasetron (Anzmet) granisetron (Kytril) ondansetron (Zofran) other medicaments hydroxyzine (Atarax, Vistaril) corticosteroids benzodiazepines cannabinoids Prokinetic gastric stimulants (gastric motility stimulants) cisapride (Propulsid)) meto
  • 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 5HT ⁇ d receptor agonists almotriptan (Axert) frovatriptan (Frova) naratriptan (Amerge) rizatriptan (Rizalt) sumatriptan (Imitrex) zolmitriptan (Zomig) ergot alkaloids dihydroergotamine (DHE) isometheptine/dichlorophenazone (Midrin) caffeine pizotifen (Sanomigran)
  • Opioid Peptides beta-endorphin dynorphin enkephalins Agonists codeine etorphine fentanyl (Sublimaze) hydrocodeine hydromo ⁇ hone rneperidine (Demerol) methadone (Dolophine) morphine oxycodone propoxyphene
  • Agonist-antagonists buprenorphine Partial Agonist dezocine (Dalgan) nalbuphine (Nubain) pentazocine (Talwain) Antagonist naloxone (Narcan)
  • ADHD Attention Deficit Hyperactivity Disorder
  • ADD Attention Deficit Disorder
  • Alzheimer's disease and Dementia Disorders Substance abuse and Addictive Disorders alcohol, tobacco and caffeine abuse Schizophrenia Depressive disorders
  • Medicaments amphetamine mixed salts (Adderall) dextroamphetamine (Dexedrine) methylphenidate (Ritalin, Concerta) Antipsychotic Medicaments (dopamine antagonists) Phenothiazine type chlo ⁇ romazine (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 (
  • HRT Hormone Replacement Therapy
  • Non-steroidal anti-inflammatory drugs 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 Medica
  • Histamine- 1 receptor antagonists brompheniramine (Dimetane) cetirizine (Zyrtec) chlo ⁇ heniramine (Chlor-Trimeton) clemastine (Tavist) cyproheptadine (Periactin) dimenhydrinate (Dramamine) diphenhydramine (Bendaryl) doxylamine (Sominex, Unisom) fexofenadine (Allegra) loratidine (Claritin) Sympathomimetic medicaments pseudoephedrine (Sudated)
  • Coagulation disorders Medicaments aspirin clopidogrel (Plavix) fibrinolytic inhibitors fibrinolytics glycoprotein (GP) ⁇ b/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)
  • Penicillins amoxicillin Amoxil Polymox
  • ampicillin Principal Polymox
  • benzathine Penicillin G benzyl Penicillin
  • Penicillin G carbenicillin
  • Geocillin carbenicillin
  • cloxacillin Cloxapen
  • dicloxacillin Dynapen
  • methicillin Staphcillin
  • mezlocillin nafcillin
  • Nafcil Unipen
  • oxacillin phenoxymethyl Penicillin Penicillin V
  • piperacillin Piperacillin
  • ticarcillin Ticar
  • Potymyxin B Protein Synthesis Inhibitors Aminoglycosides amikacin (Amikin) gentamicin (Garamycin) kanamycin (Kantrex) neomycin netilmicin (Netromycin) streptomycin tobramycin
  • DNA Gyrase Inhibitors ciprofloxacin (Cipro) gatifloxacin (Tequin) levofloxacin (Levaquin) lomefloxacin (Maxaquin) nalidixic acid ofloxacin (Floxin) Urinary Tract Antiseptics nitrolurantoin Antimyobacterial Agents

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention concerne une capsule à plusieurs compartiments comprenant une première chambre réceptrice renfermant au moins un ingrédient présentant un premier état physique, lequel ingrédient est sélectionné dans un groupe renfermant un nutraceutique, une vitamine, un complément alimentaire et un minéral ; ainsi qu'une seconde chambre réceptrice renfermant au moins un ingrédient présentant un second état physique, lequel ingrédient est sélectionné dans le groupe renfermant un nutraceutique, une vitamine, un complément alimentaire et un minéral. Selon cette invention, le premier état physique de l'ingrédient contenu dans la première chambre réceptrice est différent du second état physique de l'ingrédient contenu dans la seconde chambre réceptrice, lequel ingrédient contenu dans la première chambre réceptrice est différent de celui contenu dans la seconde chambre réceptrice.
PCT/US2003/010816 2002-04-10 2003-04-09 Systeme capsulaire a plusieurs compartiments et plusieurs phases WO2003086267A2 (fr)

Priority Applications (10)

Application Number Priority Date Filing Date Title
EP03717010A EP1499303A4 (fr) 2002-04-10 2003-04-09 Systeme capsulaire a plusieurs compartiments et plusieurs phases
AU2003220689A AU2003220689A1 (en) 2002-04-10 2003-04-09 Multi-phase, multi-compartment capsular system
JP2003583294A JP2005528383A (ja) 2002-04-10 2003-04-09 多重相・複数コンパートメントカプセルシステム
CA2481486A CA2481486C (fr) 2002-04-10 2003-04-09 Systeme capsulaire a plusieurs compartiments et plusieurs phases
NZ536267A NZ536267A (en) 2002-04-10 2003-04-09 Multi-phase, multi-compartment and multi-ingredient capsular system
US10/804,576 US7670612B2 (en) 2002-04-10 2004-03-19 Multi-phase, multi-compartment capsular delivery apparatus and methods for using same
US12/689,669 US8361497B2 (en) 2002-04-10 2010-01-19 Multi-phase, multi-compartment, capsular delivery apparatus and methods for using the same
US13/746,743 US20130136791A1 (en) 2002-04-10 2013-01-22 Multi-phase, mult-compartment capsular delivery apparatus and methods for using same
US14/036,521 US9241911B2 (en) 2002-04-10 2013-09-25 Multi-phase, multi-compartment, capsular delivery apparatus and methods for using same
US15/005,508 US9539216B2 (en) 2002-04-10 2016-01-25 Multi-phase, multi-compartment, capsular delivery apparatus and methods for using same

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
US37144802P 2002-04-10 2002-04-10
US60/371,448 2002-04-10
US10/369,247 2003-02-18
US10/369,427 2003-02-18
US10/368,951 2003-02-18
US10/369,244 2003-02-18
US10/369,247 US20030194430A1 (en) 2002-04-10 2003-02-18 Process for encapsulating multi-phase, multi-compartment capsules for therapeutic compositions
US10/369,244 US20030194429A1 (en) 2002-04-10 2003-02-18 Multi-phase, multi-compartment capsular delivery apparatus for therapeutic compositions and methods for using same
US10/368,951 US20030194428A1 (en) 2002-04-10 2003-02-18 Process for encapsulating multi-phase, multi-compartment capsules
US10/369,427 US20030194431A1 (en) 2002-04-10 2003-02-18 Multi-phase,multi-compartment capsular delivery apparatus and methods for using same

Related Parent Applications (1)

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US37144802P Substitution 2002-04-10 2002-04-10

Related Child Applications (1)

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US10/804,576 Continuation-In-Part US7670612B2 (en) 2002-04-10 2004-03-19 Multi-phase, multi-compartment capsular delivery apparatus and methods for using same

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WO2003086267A2 true WO2003086267A2 (fr) 2003-10-23
WO2003086267A3 WO2003086267A3 (fr) 2003-12-18
WO2003086267B1 WO2003086267B1 (fr) 2004-04-29

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EP (1) EP1499303A4 (fr)
JP (2) JP2005528383A (fr)
AU (3) AU2003220689A1 (fr)
CA (1) CA2481486C (fr)
NZ (1) NZ536267A (fr)
WO (1) WO2003086267A2 (fr)

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WO2005063016A1 (fr) * 2003-12-19 2005-07-14 Bayer Technology Services Gmbh Formulation d'agents actifs a plusieurs phases
EP1562563A2 (fr) * 2002-10-31 2005-08-17 National Jewish Medical and Research Center Methodes pour le traitement de maladies caracterisees par une deficience en composes contenant du thiol
JP2006321730A (ja) * 2005-05-17 2006-11-30 Maruzen Pharmaceut Co Ltd 抗酸化剤及び抗老化剤、並びに皮膚化粧料及び飲食物
EP1735004A1 (fr) * 2004-04-07 2006-12-27 Resveratrol Partners, LLC Supplement dietetique et procede de traitement de ce dernier
US7790762B2 (en) 2002-10-31 2010-09-07 National Jewish Health Compounds and methods for thiol-containing compound efflux and cancer treatment
US7867524B2 (en) 2007-10-05 2011-01-11 David Rowland Energizing formulation
WO2010122499A3 (fr) * 2009-04-20 2011-05-19 Ecole Polytechnique Federale De Lausanne (Epfl) Récipients assemblés dans un fluide et production correspondante
CN102335095A (zh) * 2011-10-12 2012-02-01 李思思 d-柠檬烯硬胶囊的一种制造技术
WO2012047207A1 (fr) * 2010-10-05 2012-04-12 Sam Poon Ang Compositions pour traitement d'infections virales chroniques
US8383579B2 (en) 2004-11-19 2013-02-26 GlaxoSmithKline, LLC Method for customized dispensing of variable dose drug combination products for individualizing of therapies
US8440224B2 (en) 1999-07-30 2013-05-14 Capsugel Belgium Nv Multi-component pharmaceutical dosage form
US9132082B2 (en) 2005-05-11 2015-09-15 Vecta, Ltd. Compositions and methods for inhibiting gastric acid secretion
US9233092B2 (en) 2006-07-25 2016-01-12 Vecta, Ltd. Compositions and methods for inhibiting gastric acid secretion using derivatives of small dicarboxylic acids in combination with PPI
US9278080B2 (en) 2005-05-11 2016-03-08 Vecta, Ltd. Compositions and methods for inhibiting gastric acid secretion
US9301988B2 (en) 2007-03-30 2016-04-05 Hi-Tech Pharmacal Co., Inc. Method of treatment using a therapeutic agent for intranasal administration
EP3446687A1 (fr) * 2010-06-03 2019-02-27 Catalent Ontario Limited Capsules de gel souples à plusieurs phases, appareil et procédé associés
US10668089B2 (en) 2006-06-21 2020-06-02 Opko Ireland Global Holdings, Ltd. Method of treating and preventing secondary hyperparathyroidism
US11007204B2 (en) 2006-02-03 2021-05-18 Opko Renal, Llc Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3
US11007205B2 (en) 2014-08-07 2021-05-18 Eirgen Pharma Ltd. Adjunctive therapy with 25-hydroxyvitamin D and articles therefor
WO2021124244A1 (fr) * 2019-12-20 2021-06-24 Idi Integratori Dietetici Italiani S.R.L. Microparticules gastrorésistantes comprenant de l'inositol et/ou de l'extrait de gymnema sylvestre, compositions pharmaceutiques et nutraceutiques et utilisations associées
US11154509B2 (en) 2007-04-25 2021-10-26 Eirgen Pharma Ltd. Methods for controlled release oral dosage of a vitamin D compound
US11173168B2 (en) 2016-03-28 2021-11-16 Eirgen Pharma Ltd. Methods of treating vitamin D insufficiency in chronic kidney disease
US11253528B2 (en) 2013-03-15 2022-02-22 Eirgen Pharma Ltd. Stabilized modified release Vitamin D formulation and method of administering same
US11672809B2 (en) 2010-03-29 2023-06-13 Eirgen Pharma Ltd. Methods and compositions for reducing parathyroid levels
US11752158B2 (en) 2007-04-25 2023-09-12 Eirgen Pharma Ltd. Method of treating vitamin D insufficiency and deficiency

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US7781572B2 (en) * 2005-10-05 2010-08-24 Nse Products, Inc. Nanosized carotenoid cyclodextrin complexes
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US8967989B2 (en) * 2010-07-19 2015-03-03 Procaps SAS Apparatus and process for encapsulating capsules or other solid dosage forms within capsules
US10130760B2 (en) 2013-03-15 2018-11-20 Incube Labs, Llc Multi-stage biodegradable drug delivery platform
US9980993B2 (en) 2014-11-06 2018-05-29 NWO Stem Cure, LLC Nutraceutical supplement with Lactobacillus rhamnosus
US9468659B2 (en) 2014-11-06 2016-10-18 NWO Stem Cure, LLC Nutraceutical supplement with Lactobacillus rhamnosus
CN108753621A (zh) * 2018-05-30 2018-11-06 昆明理工大学 一种基于糖蜜废醪液提高单针藻油脂积累的方法
JP7229012B2 (ja) 2018-12-25 2023-02-27 小林製薬株式会社 内服用医薬組成物
CN116648239A (zh) * 2021-08-26 2023-08-25 宁德时代新能源科技股份有限公司 液囊、电池单体、电池和用电装置

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Cited By (32)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8440224B2 (en) 1999-07-30 2013-05-14 Capsugel Belgium Nv Multi-component pharmaceutical dosage form
US7790762B2 (en) 2002-10-31 2010-09-07 National Jewish Health Compounds and methods for thiol-containing compound efflux and cancer treatment
EP1562563A2 (fr) * 2002-10-31 2005-08-17 National Jewish Medical and Research Center Methodes pour le traitement de maladies caracterisees par une deficience en composes contenant du thiol
EP1562563A4 (fr) * 2002-10-31 2005-12-28 Nat Jewish Med & Res Center Methodes pour le traitement de maladies caracterisees par une deficience en composes contenant du thiol
US7498047B2 (en) 2002-10-31 2009-03-03 National Jewish Medical And Research Center Methods for treatment of thiol-containing compound deficient conditions
WO2005063016A1 (fr) * 2003-12-19 2005-07-14 Bayer Technology Services Gmbh Formulation d'agents actifs a plusieurs phases
EP1735004A1 (fr) * 2004-04-07 2006-12-27 Resveratrol Partners, LLC Supplement dietetique et procede de traitement de ce dernier
EP1735004A4 (fr) * 2004-04-07 2011-11-09 Resveratrol Partners Llc Supplement dietetique et procede de traitement de ce dernier
US8383579B2 (en) 2004-11-19 2013-02-26 GlaxoSmithKline, LLC Method for customized dispensing of variable dose drug combination products for individualizing of therapies
US9370481B2 (en) 2005-05-11 2016-06-21 Vecta, Ltd. Compositions and methods for inhibiting gastric acid secretion
US9132082B2 (en) 2005-05-11 2015-09-15 Vecta, Ltd. Compositions and methods for inhibiting gastric acid secretion
US9278080B2 (en) 2005-05-11 2016-03-08 Vecta, Ltd. Compositions and methods for inhibiting gastric acid secretion
JP2006321730A (ja) * 2005-05-17 2006-11-30 Maruzen Pharmaceut Co Ltd 抗酸化剤及び抗老化剤、並びに皮膚化粧料及び飲食物
US11911398B2 (en) 2006-02-03 2024-02-27 Opko Renal, Llc Treating Vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3
US11007204B2 (en) 2006-02-03 2021-05-18 Opko Renal, Llc Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3
US10668089B2 (en) 2006-06-21 2020-06-02 Opko Ireland Global Holdings, Ltd. Method of treating and preventing secondary hyperparathyroidism
US9233092B2 (en) 2006-07-25 2016-01-12 Vecta, Ltd. Compositions and methods for inhibiting gastric acid secretion using derivatives of small dicarboxylic acids in combination with PPI
US9301988B2 (en) 2007-03-30 2016-04-05 Hi-Tech Pharmacal Co., Inc. Method of treatment using a therapeutic agent for intranasal administration
US11154509B2 (en) 2007-04-25 2021-10-26 Eirgen Pharma Ltd. Methods for controlled release oral dosage of a vitamin D compound
US11752158B2 (en) 2007-04-25 2023-09-12 Eirgen Pharma Ltd. Method of treating vitamin D insufficiency and deficiency
US7867524B2 (en) 2007-10-05 2011-01-11 David Rowland Energizing formulation
WO2010122499A3 (fr) * 2009-04-20 2011-05-19 Ecole Polytechnique Federale De Lausanne (Epfl) Récipients assemblés dans un fluide et production correspondante
US11672809B2 (en) 2010-03-29 2023-06-13 Eirgen Pharma Ltd. Methods and compositions for reducing parathyroid levels
US11173125B2 (en) 2010-06-03 2021-11-16 Catalent Ontario Limited Multiphase soft gel capsules, apparatus and method thereof
EP3446687A1 (fr) * 2010-06-03 2019-02-27 Catalent Ontario Limited Capsules de gel souples à plusieurs phases, appareil et procédé associés
WO2012047207A1 (fr) * 2010-10-05 2012-04-12 Sam Poon Ang Compositions pour traitement d'infections virales chroniques
CN102335095A (zh) * 2011-10-12 2012-02-01 李思思 d-柠檬烯硬胶囊的一种制造技术
US11253528B2 (en) 2013-03-15 2022-02-22 Eirgen Pharma Ltd. Stabilized modified release Vitamin D formulation and method of administering same
US11007205B2 (en) 2014-08-07 2021-05-18 Eirgen Pharma Ltd. Adjunctive therapy with 25-hydroxyvitamin D and articles therefor
US11738033B2 (en) 2014-08-07 2023-08-29 Eirgen Pharma Ltd. Adjunctive therapy with 25-hydroxyvitamin D and articles therefor
US11173168B2 (en) 2016-03-28 2021-11-16 Eirgen Pharma Ltd. Methods of treating vitamin D insufficiency in chronic kidney disease
WO2021124244A1 (fr) * 2019-12-20 2021-06-24 Idi Integratori Dietetici Italiani S.R.L. Microparticules gastrorésistantes comprenant de l'inositol et/ou de l'extrait de gymnema sylvestre, compositions pharmaceutiques et nutraceutiques et utilisations associées

Also Published As

Publication number Publication date
AU2011202164A1 (en) 2011-06-02
CA2481486A1 (fr) 2003-10-23
AU2003220689A1 (en) 2003-10-27
WO2003086267B1 (fr) 2004-04-29
NZ536267A (en) 2007-06-29
JP2011068664A (ja) 2011-04-07
WO2003086267A3 (fr) 2003-12-18
AU2009202495A1 (en) 2009-07-16
JP2005528383A (ja) 2005-09-22
EP1499303A4 (fr) 2007-07-25
CA2481486C (fr) 2012-06-12
AU2009202495B2 (en) 2011-02-10
EP1499303A2 (fr) 2005-01-26

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