MXPA06005158A - Multi-site drug delivery platform - Google Patents

Abstract

A pharmaceutical composition (10) for administration to a patient body. The composition (10) includes a physiologically-acceptable formulation including at least one active pharmaceutical ingredient, wherein said physiologically-acceptable formulation including said at least one active pharmaceutical ingredient is provided in a delivery form (12), said delivery form (12) being administrable to a patient body through a plurality of administration routes, which include the oral and rectal routes.

Description

PLATFORM OF MULTI-SITE DRUGS SUPPLY FIELD OF THE INVENTION The present invention relates generally to drugs and drug delivery systems, and specifically to drugs and drug delivery systems designed to be delivered by means of multiple alternate delivery sites.

BACKGROUND OF THE INVENTION Non-parenteral drugs, which are in forms of delivery such as tablets, suspensions, suppositories, etc., are generally adapted to be administered to a patient by means of a delivery site or individual route of administration. For example, a chewable tablet is designed to be administered only through the oral cavity, and its particular formulation is adapted to be delivered in that particular form. If a particular drug requires administration via an alternate route of administration, such as a suppository, which is delivered via the rectum, a different formulation including the drug will be used. There are several drawbacks resulting from drug delivery forms that allow only administration of a particular formula to a patient by means of a delivery site or individual route of administration. One such drawback relates to situations in which it may become difficult or impossible to administer a medication by means of a particular route of administration. As a first example, a group of patients in which this inconvenience may be frequent, is formed of children. Many medications are dispensed as tablets or other forms designed to be taken orally, such as suspensions. However, sick children have a propensity to become "capricious", especially when they are sick, and thus they come to reject oral ingestion of medications. When this occurs, the medication may not be taken in the correct amounts, at the right time, or in any way, and compliance with the medical regimen is impaired. Without proper compliance, children's health can get worse. This only complicates the problem, because many sick children often become even less cooperative, as the symptoms of illness or discomfort become more intense. As a result of this drawback, a preparation that can be administered rectally as a suppository can allow compliance with the medical regimen, thus resolving the child's health problems, and resolving a potentially emotionally charged family crisis, providing the medication in a form of supply that can be administered in the event that the supply through the oral route is improbable or impossible.

However, common rectal suppositories, which include pharmaceutical ingredients, are prepared in a delivery formulation that differs from the formulation used for a delivery form adapted for oral administration. In this way, the oral tablet, gel, etc., can not be administered rectally. In this way, in order to solve the problem of the non-cooperative patient, two different forms of the same medication, one oral and one rectal, need to be kept at hand. Said solution is theoretical and generates unnecessary costs from the point of view of the producer, who must generate pharmaceutical compositions in two separate supply forms, and from the point of view of the client, who must purchase pharmaceutical compositions in two separate supply forms. A second example of problems with compliance may arise when the intrinsic nature of many severe health problems that commonly affect patients makes swallowing problematic. For example, gastrointestinal diseases, which include nausea and vomiting; asthma, which includes air gasping; seizures, which include a change in mental state; and pharyngitis and other diseases, including a severe sore throat, are examples of conditions and symptoms that often make it desirable to have a medication that is available through a different route of the oral cavity. Even the most cooperative patients, those who want to take oral medications, often can not swallow pills, tablets, etc., when they suffer from nausea and vomiting, when they gasp for air from an asthma attack, when they become incapacitated during a seizure, or when they become anxious about severe throat pain. As a third example, certain situations may require urgent or emergent supply of medication. In such situations, it may be the case that a particular form of supply is theoretical or impossible to supply. For example, it may be impossible to administer a form of oral delivery of a composition to an incapacitated individual. Said individual may require an alternative form of supply. In such cases, having the wrong supply form of a medication on hand, can have serious, and possibly even fatal, consequences. Thus, for acutely ill patients and patients chronically dependent on medications, it is evident that a drug supply may be preferable by means of a route of administration on one occasion, and on another occasion it may be preferable or required by means of a route of different administration, even when applied to the same disease and even during the same course of the same day. Thus, to eliminate the above drawbacks in common drugs and drug regimens, it would be desirable to develop a drug composition that allows administration at different sites of a patient to allow compliance with a medication regimen when a particular route of administration is used. not available In addition, it would be desirable to provide a drug in a form of supply that allows a prescription to be described and filled without varying the formulations. Furthermore, it would be desirable to allow early resolution of emergencies, providing an individual form of supply that can be administered regardless of the patient's status.

BRIEF DESCRIPTION OF THE INVENTION The present invention overcomes the drawbacks described above in the background of the invention. It does so by providing a pharmaceutical composition for administration to a patient's body, which includes a physiologically acceptable formulation having an active pharmaceutical ingredient, wherein the formulation is provided in a single delivery form that can be administered to a patient through a plurality of of administration routes. By providing a formulation in an individual supply form administrable by alternate routes, the present invention allows a medication regimen to be met when a particular route of administration is not available. In addition, the present invention allows a prescription to be described and filled without varying the formulation of the composition. Still further, the present invention provides a composition that can be administered rapidly, regardless of the age or condition of the patient, or the symptoms exhibited by the patient. The present invention thus includes multiple delivery forms designed to allow the administration of physiologically acceptable biologically active substances, with each form of supply available to the body of a patient by means of a plurality of administration routes. These forms of supply can include solid and non-solid forms. The routes of administration used with these delivery forms may include oral transmucosal, rectal and oral mucosa through the gastrointestinal tract. When the drug delivery form is solid, the present invention may include a physiologically acceptable biologically active composition in the form of a lozenge on a handle in the form of a paddle or pacifier for transmucosal and / or gastrointestinal absorption, a lozenge out of a handle for oral transmucosal and / or gastrointestinal absorption, a swallowable tablet, a chewable tablet, or a dissolvable tablet for gastrointestinal absorption, a capsule including a soft gel capsule, and a rectal suppository for rectal absorption. When the delivery form is non-solid, routes of administration may include oral, via the gastrointestinal tract or oral mucosa, and rectal administration. The non-solid delivery form may include a physiologically acceptable biologically active composition, such as a gel, liquid, paste or foam. These non-solid preparations can be enclosed in a capsule that includes a soft gel capsule that can be administered orally and rectally, for oral and gastrointestinal and / or rectal transmucosal absorption. The non-solid delivery form can be applied by means of an applicator if administered orally or rectally. The solid delivery form, including capsule and soft gel capsule, can also be applied by means of an applicator, if administered orally or rectally. The composition in the delivery forms of the present invention can be used with short-acting and long-acting drug preparations. As a result, health problems, urgent and emerging, seizures, asthma attacks and dehydration from vomiting, can be solved by means of delivery of the composition of the present invention. For example, diazepam, aminophylline and / or promethazine can be administered rectally or alternatively orally with a transmucosal pallet delivery form or a chewable or swallowable capsule or tablet that can also be used as a suppository. As described above, in urgent and emergent situations, the time lost in the search for the correct supply form can have serious and even fatal consequences. By the present invention, a particular formulation can be immediately adapted to the necessary delivery form. In addition, the same tablet can be used orally or rectally. Previously rectal administrations require a different formulation than a form for oral administration. By providing formulations in a form of supply that are suitable for administration by a plurality of administration routes, the composition of the present invention can also result in significant cost savings. For example, said savings can be generated directly through the lower cost of having a formula in an individual supply form, against the higher cost of formulations of the same drug in different forms of supply, and indirectly, for example, reducing the loss of time for parents and guardians and the costs associated with calls to doctors, trips from one side to another for visits to doctors and pharmacists, etc. The significant costs associated with the health care system can also be significantly reduced. For example, the time that pharmacists require to prepare different forms of drug delivery can be significantly reduced. In addition, a doctor may be able to write a single prescription for a drug that can then be used in different ways. The benefits of the composition of the present invention may be pronounced especially in certain patients, such as children. As discussed above, it is well known that sick children are less than attentive to their medication regimen. Often, children will easily reject medications, unless the formulation is adapted at that particular time. At one point, a sick child may accept an oral medication, but not at another time, may even reject the idea of taking a pill. In addition, certain situations may arise where any patient, whether child or adult, is reluctant or unable to take a medication in a certain form of supply. Being able to easily switch from one administration route to another, the drug delivery systems of the present invention are allowed to resolve otherwise critical situations. The composition in the delivery forms of the present invention thus solves the drawbacks described above in the background of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in the specification and constitute a part thereof, illustrate embodiments of the invention and, together with a general description of the invention given above, and the detailed description of the modalities given below, they serve to explain the principles of the invention. Figure 1 is a perspective view of a pharmaceutical composition in a form of supply, adapted to be supplied as a suppository or tablet; Figure 2 is a perspective view of the pharmaceutical composition of the delivery form of Figure 1 and a handle for better adapting the composition for oral administration as a paddle allowing transmucosal and / or gastrointestinal absorption; Figure 3 is a perspective view of the pharmaceutical composition and handle of Figure 2 operatively connected for oral administration of the pharmaceutical composition; Figure 4 is a perspective view of the threaded tip of the handle as described in Figure 2; Figure 5 is a perspective view of an alternative embodiment of a pharmaceutical composition in a form of supply, adapted to be supplied as a suppository or tablet; Figure 6 is a perspective view of a pharmaceutical composition in a form of supply, adapted to be supplied as a suppository or tablet, and including a marked line; and Figure 7 is a perspective view of an applicator used to provide a non-solid delivery form of the pharmaceutical composition of the present invention.

DETAILED DESCRIPTION OF THE INVENTION The present invention provides a composition for administration to the body of a patient, which includes a physiologically acceptable formulation having an active pharmaceutical ingredient, wherein the formulation is provided in a form of delivery that can be administered to a patient through a plurality of routes of administration. It also provides a method of administering the composition to a patient by alternative routes of administration. In one embodiment of the present invention, the route of administration by which the composition may be administered to a patient may be an oral route of administration. The oral administration route for absorption of the active pharmaceutical ingredient of the formulation can be transmucosal or gastrointestinal. For example, when the route of administration is oral transmucosal, the composition can be adapted for absorption through the buccal, sublingual and / or gingival mucosa. In an alternative embodiment, the route of administration may be a rectal administration route, and more particularly, a rectal transmucosal route. It will be apparent to those skilled in the art that while the routes of administration may include oral and rectal, they are not limited to the oral and rectal routes. As will be recognized by those skilled in the relevant art, the routes of administration may include any suitable route for any form of delivery of the composition of the present invention. In addition, the composition of the present invention can include a delivery form that is solid or non-solid. All drugs that are available in suppository form can be used in the solid delivery form of the present invention. All drugs that are available in an oral liquid form can be used in the non-solid delivery form of the present invention. Non-solid delivery forms can include those that are semi-solid, such as a gel.

In addition, the drug delivery forms of the present invention are adaptable to all drugs that can be adapted in a capsule, including a soft gel capsule. In addition, the drug delivery forms of the present invention are adaptable to all drugs that are suitable for oral and rectal use. When the form of delivery of the composition of the present invention is a solid supply form, said form of delivery may include a suppository, a pill, a swallowable tablet, a chewable tablet, a dissolvable tablet, or a capsule. Said solid delivery form is shown in Figure 1. Those skilled in the art will recognize that the above list of solid delivery forms is only an example, and that any form of solid delivery that is administrable to a patient may be suitable for use in the present invention. In use, solid delivery forms, such as those described above, can be administered orally. For example, forms such as the tablet forms described above, can be taken by swallowing the whole tablet or capsule, chewing the tablet, or allowing the tablet to dissolve prior to administration to or during the oral cavity. A pill form can be swallowed, chewed or dissolved in the mouth, or can be attached to a handle to be administered as a paddle, as will be better described later. If the solid delivery form, as described above, can not be taken or taken orally, it can be administered rectally, without any need to alter the formulation of the composition. Tablets can be manufactured by direct compression, wet granulation, or any other technique used in the manufacture of tablets. They can be manufactured by any technique used in the manufacture of capsules, including soft gel capsules. Referring now to Figures 1 to 4, there is shown an example of a solid supply form 12 as a suppository, and how it can be adapted for use as a chewable tablet, swallowable tablet, dissolvable tablet, tablet or palette. For example, composition 10 in a particular formulation that includes an active pharmaceutical ingredient may have a solid suppository form 12, as shown in Figure 1. However, it may not be easy to induce a particular patient , such as a child, take the medication in the form of a suppository. However, the child may be much more willing to accept taking the medication in the form of a palette. Thus, in one embodiment, the delivery form 12 can be adapted to include a handle 14, the handle 14 being adapted to be operatively connected to the solid delivery form 12. In the illustrated embodiment, the suppository includes a proximal end 16 and a distal end 18. The distal end 18 defines a central hole 20 that is adapted to receive a handle 14. When the handle 14 is not in the receiving relationship with the hole 20, the composition 10 can be administered as a suppository, lozenge or tablet. When the handle 14 is in receiving relationship with the hole 20, as seen more readily in Figure 3, the composition 10 in this delivery form 12 can be used as a pallet. To facilitate this adaptation, the handle 14 can be threaded, as shown in Figure 4 (at reference number 22), so that it can be received by the hole 20, as shown in Figures 2 and 3. described briefly above, there are several modes of the solid delivery form that can be adapted for administration to a patient through various administration sites in a patient's body. Such modalities include, but are not limited to, a pallet (pill on a handle), a troche or pill (out of a handle), a suppository (out of a handle), a dissolvable tablet (out of a handle), a swallowable tablet (out of a handle) and a chewable tablet (on a handle or outside of it). In a particular embodiment of the solid delivery form of the present invention, the composition may include a flat oval base with rounded edges like the shape of a tablet. This tablet, as can be seen in figures 1 to 4, can define a threaded passage, so that the tablet can be adapted to be connected to a complementary threaded handle. Those skilled in the art will recognize that other forms, different from that described above, may be possible in a solid supply form, so long as they remain consistent with the principles of the present invention. For example, such embodiments may include a supply form without a handle that has no threaded hole or handle (ie, a chewable, swallowable and suppository shape without a threaded hole or handle, as can be seen in Figures 5 and 6). ). As described above, the delivery form of the composition of the present invention may also include non-solid delivery forms. When a non-solid delivery form is selected, the delivery form may include, but is not limited to, a gel, a liquid, a paste and a foam. A non-solid form of supply may be preferable at times, because there are certain situations where a non-solid form of supply may be more suitable than a solid form of supply. These include, (1) use with younger children who face difficulties with solid formulations, (2) use for drugs that have poor acceptability - taste masking is easier with liquid formulations - and (3) use with drugs that require higher doses, since it is easier to provide higher concentrations of active pharmaceutical ingredients in non-solid forms. When presented as a gel, paste or foam, the non-solid supply form is also a semi-solid. In such form, the active pharmaceutical ingredient can be combined with other components, such as excipients, which are selected and mixed with the active pharmaceutical ingredient or ingredients to give a delivery form of the desired consistency, by methods well known to the skilled artisan. in the technique. When presented as a non-solid liquid, the delivery form may be presented as a suspension, solution, or in the form of an aerosol or other form of liquid supply. Said form may typically include a solution or suspension of the active ingredient or pharmaceutical ingredients in a physiologically acceptable aqueous solvent. A liquid suspension can be administered orally or rectally. An aerosol formulation may be administrable orally or nasally. Those skilled in the art will recognize that the forms of delivery and routes of administration discussed above are examples, and that the non-solid delivery forms may be administrable to a patient by any suitable means. To facilitate the administration of the non-solid supply form, an applicator including a supply component can also be provided. This supply component can be a piston, or a resilient housing or body, for example. Those skilled in the art will recognize that any structure that facilitates the delivery of the non-solid delivery form can be used as the delivery component of this embodiment of the present invention. Referring now to Figure 7, a particular embodiment is shown in a non-solid delivery form. The applicator in this embodiment may be a syringe 26 having a barrel 28, a distal tip 30 and a plunger 32. The composition, in a non-solid form, is contained within the barrel 28 before use. By oppressing the plunger 32, the composition can leave the barrel 28 through the lip 30, to be dispensed to a patient through one of multiple administration routes, such as oral or rectal. The syringe may include first and second dosage lines 35, 36. These can be used to determine different dosages to be administered, depending on the route of administration. For example, when the composition is administered rectally, the plunger 32 may be depressed to the first dosage line 34. However, when the composition is administered orally, the plunger 32 may be depressed to the second dosage line 36. As described above, the formulation of the composition includes an active pharmaceutical ingredient. This active pharmaceutical ingredient can be selected from analgesics, anti-allergy medications, anti-asthma medications, antibiotics, antiviral drugs, antifungal drugs, anticholinergics, anticonvulsants, antidepressants, antihistamines, antiemetics, antiepileptics, antispasmodics, aminophylline, ascorbic acid, aspirin, acetaminophen, barbiturates, benzodiazepines, bisacodyl, butyrophenones, caffeine, doral hydrate, chlorpromazine, clindamycin, clotrimazole, codeine, corticosteroids, dextromethorphan, diazepam, dinoprostone, diphenhydramine, ergotamine, estrogens, fentanyl, ferrous sulfate, guaifenesin, haloperidol, hormonal supplements, hydromorphone, indomethacin, kaolin, pectin, laxatives, lithium, loperamide, meclizine, meprobamate, methadone, metronidazole, miconazole, morphine, NSAIDs, opioids, orphenadrine, oxymorphone, pentobarbital, phenobarbital, phenothiazines, phenytoin, prochlorperazine, progestins, promethazine, ritalin, simethicone, spir amicin, sulfonamides, theophylline, trimethobenzamide, valproic acid and vitamins. Those skilled in the art will recognize that the above list of active pharmaceutical ingredients is only one example, and that any active pharmaceutical ingredient that is suitable for combination in a composition in a delivery form as described herein, can be used in the formulation of the composition of the present invention. Those skilled in the art will further recognize that it is not necessary that only an active pharmaceutical ingredient be included in the composition of the present invention, but that a plurality of active pharmaceutical ingredients can be included in the composition. As described above, the composition of the present invention can include different components of the active pharmaceutical ingredient. These components may include a base present in the formulation that makes the formulation suitable for oral and rectal applications. In particular embodiments, this base can be selected from glycerinated gelatin, polyethylene glycol and MBK fatty acid. The components of the composition can also include at least one additive, and in general a plurality of additives, used to maximize the acceptability of the composition, in terms of characteristics such as masking of taste, texture and color. These additives include, but are not limited to, flavoring agents, coloring agents, sweetening agents, preservatives, adhesion promoting agents and slip agents. The components of the composition may further include at least one excipient. Said excipient may be used for various purposes, such as to facilitate tabletting, or to facilitate the dissolution of the delivery form in the mouth. This excipient (at least one) can be selected from the group consisting of mannitol, dextrose, lactose, sucrose and calcium carbonate. With certain active pharmaceutical ingredients, the absorption of the ingredient in the patient's body can occur more rapidly and / or completely through rectal absorption than through oral gastrointestinal or transmucosal absorption. For example, methadone may exhibit up to about 80 to 100% absorption when administered rectally (J. S. Morley, New Perspectives in Our Use of Opioids, Pain Forum, 8: 4 (1999), 200-205; E. Bruera, et al., Methadone Use in Cancer Patients with Pain: A Review, J. Palliative Medicine, 5 (2002) 127-138; C. Ripamonti, et al., Switching from Morphine to Oral Methadone in Treating Cancer Pain: What is an Equianalgesic Dose Ration ?, Journal of Clinical Oncology, 16:10 (1998), 3216-3218), while the same pharmaceutical ingredient Active can exhibit substantially less than about 60 to 80% absorption in the patient's body when administered orally (JS Morley, New Perspectives in Our Use of Opioids, Pain Forum, 8: 4 (1999), 200-205; Bruera, et al., Methadone Use in Cancer Patients with Pain: A Review, J. Palliative Medicine, 5 (2002) 127-138; C. Ripamonti, et al., Switching from Morphine to Oral Methadone in Treating Cancer Pain: What is an Equianalgesic Dose Ration '?, Journal of Clinical Oncology, 16: 10 (1998), 3216-3218). As described above, a particular form of delivery, such as a tablet, can be administrable orally or rectally, without having to obtain a different formulation of the composition. In this way, the concentration of the active pharmaceutical ingredient administered will be the same, regardless of whether the composition is administered orally or rectally. However, due to different absorption regimes of some ingredients, such as methadone, based on the selected route of administration, it may be desirable in some circumstances to alter the form of delivery to result in equal amounts of the active pharmaceutical ingredient that is absorbed regardless of the route of administration. Thus, in one embodiment of the composition having a solid delivery form 12, such as a tablet as shown in Figure 6, the tablet is provided with an incision line 24. This incision line 24 can be provided at the surface of the tablet, or other form of solid supply 12. The location of the incision line 24 in the tablet may reflect the absorption regimes of the active pharmaceutical ingredient in the intestine or rectum of a patient. For example, if a particular composition includes an active pharmaceutical ingredient of methadone, and that ingredient exhibits 100% absorption when administered rectally, but only 75% absorption when taken orally, then the tablet may include an incision line that makes that the tablet breaks unevenly in two portions, one of those portions being 75% of the original tablet. Referring again to Figures 1-7, it can be seen that the tablet in one embodiment of the present invention includes a distal end 18 and a proximal end 16. In the example described above then, the tablet would have a localized incision line 24 on the tablet, 75% of the total length of the tablet from the proximal insertion end 16 of the suppository. If 100% absorption is needed to produce a therapeutic result, the entire tablet would be administered orally, if that is the administration route of choice. However, if the composition had to be administered rectally, then the tablet would be broken first along the incision line, and the portion exhibiting 75% of the total size of the original tablet would be administered rectally. As a separate example, if a particular composition includes an acetaminophen active pharmaceutical ingredient, because higher plasma drug levels are achieved after oral doses compared to rectal doses, there may be a need for a higher rectal dose compared to the oral dose. If 100% absorption is needed to produce a therapeutic result, the whole suppository tablet containing acetaminophen would be administered rectally, if that is the administration route of choice. However, if the composition had to be administered orally, then the tablet-suppository would have to be broken first along the incision line, and the portion that exhibits 75% of the total size of the original tablet would be administered orally. The present invention also provides a method of administering the composition to a patient. This method includes providing a composition for administration to a patient's body, which includes a physiologically acceptable formulation having an active pharmaceutical ingredient, wherein the formulation is provided in a form of delivery that can be administered to a patient's body through a plurality of administration routes. The method further includes selecting at least a first or a second route of administration, and delivering the composition in a form of delivery to the patient via the first route of administration or the second route of administration. A first administration route that can be selected includes oral administration. A second route of administration that can be selected includes rectal administration. As described above, the route of administration to be selected may depend on several factors including, but not limited to, the age of the patient, the patient's symptoms and the patient's condition (ie, if the patient is incapacitated) . As described above, when the composition of the present invention is administered to the body of a patient, the delivery form can be adapted for delivery, such as by operatively connecting a handle to a solid supply form, or breaking a solid delivery form to along an incision line arranged on the surface of the supply form. The principles of the present invention will be more apparent with respect to the following examples.

EXAMPLES EXAMPLE 1 Promethazine The following example includes the amounts of ingredients in a solid supply form adapted to be used as a suppository in various mold sizes, which allows various potencies for administration at different patient ages. A form of supply produced in a mold 1.3 Gm, is suitable for children from 3 to 6 years of age. A form of supply produced in a mold 2.0 Gm, is suitable for children from 6 to 12 years of age. And a form of supply produced in a mold 2.3 Gm, is suitable for adults. Each form of supply is prepared for use as a suppository. However, in case the medication can not be administered rectally, the medication can be taken orally alternatively. The various amounts of ingredients are the following: Prometazine 12.5 mg / mold 1.3 Gm Promethazine 12.50 mg Stevia powder 2.00 mg Silica gel 1.30 mg MBK fat base 1.285 g Flavor / orange concentrate 0.13 ml Prometazine 12.5 mg / mold 2.0 Gm Promethazine 25.00 mg Stevia powder 3.00 mg Silica gel 2.00 mg MBK fat base 1.970 g Taste / orange concentrate 0.23 ml Prometazine 12.5 mg / mold 2.3 Gm Promethazine 50.00 mg Stevia powder 3.50 mg Silica gel 2.30 mg MBK fat base 2.244 g Orange flavor / concentrate 0.26 mi EXAMPLE 2 Acetaminophen The following example includes the amounts of ingredients in a solid supply form adapted to be used as a suppository in various mold sizes, which allows various potencies for administration at different patient ages. A form of supply produced in a mold 1.3 Gm, is suitable for children from 3 to 6 years old. A form of supply produced in a mold 2.0 Gm, is suitable for children from 6 to 12 years of age. And a form of supply produced in a mold 2.3 Gm, is suitable for adults. Each form of supply is prepared for use as a suppository. However, in case the medication can not administered rectally, the medication can be taken orally alternatively. The various amounts of ingredients are the following: Acetaminophen 120 mg / mold 1.3 Gm Acetaminophen 120.00 mg Stevia powder 2.00 mg MBK fat base 1.178 g Taste / orange concentrate 0.13 ml Acetaminophen 350 mg / mold 2.0 Gm Acetaminophen 350.00 mg Stevia powder 3.00 mg MBK fat base 1.672 g Taste / orange concentrate 0.23 ml Acetaminophen 750 mg / mold 2.3 Gm Acetaminophen 750.00 mg Stevia powder 3.50 mg MBK fat base 2.547 g Flavor / orange concentrate 0.26 mi EXAMPLE 3 Acetaminophen; codeine The following example includes the amounts of ingredients in a solid supply form adapted to be used as a suppository in various mold sizes, which allows various potencies for administration at different patient ages. A form of supply produced in a mold 1.3 Gm, is suitable for children from 3 to 6 years old. Each form of supply is prepared for use as a suppository. However, in case the medication can not be administered rectally, the medication can be taken orally alternatively. The various amounts of ingredients are the following: Acetaminophen 120 mg, codeine 12.5 mg / mold 2.3 Gm Acetaminophen 120.00 mg Codeine 12.50 mg Sfew'a powder 2.40 mg MBK fat base 1.165 g Orange flavor / concentrate 0.13 ml Although the present invention has been described with reference to the details of preferred embodiments of the invention, it will be understood that the description is intended to be used in an illustrative sense rather than in a limiting sense, since it is contemplated that modifications will more readily occur to those skilled in the art, within of the spirit of the invention and the scope of the amended claims.

Claims (38)

NOVELTY OF THE INVENTION CLAIMS

1. - A pharmaceutical composition for administration to the body of a patient, comprising: a physiologically acceptable formulation that includes at least one active pharmaceutical ingredient; wherein said physiologically acceptable formulation that includes said active pharmaceutical ingredient (at least one) is provided in a form of delivery, said form of delivery being alternatively administrable to the body of a patient through an oral administration route and a rectal administration route.

2. The composition according to claim 1, further characterized in that said oral administration route is selected from the group consisting of an oral transmucosal route and an oral gastrointestinal route.

3. The composition according to claim 1, further characterized in that said rectal administration route further comprises a rectal transmucosal route.

4. The composition according to claim 1, further characterized in that said form of supply is selected from the group consisting of a solid delivery form and a non-solid supply form.

5. - The composition according to claim 4, further characterized in that said solid delivery form is selected from the group consisting of a suppository, a tablet, a swallowable tablet, a chewable tablet and a dissolvable tablet.

6. The composition according to claim 5, further characterized in that said physiologically acceptable formulation further includes at least one additive selected from the group consisting of flavoring agents, coloring agents, sweetening agents, preservatives, adhesion-promoting agents and preservatives. glide.

7. The composition according to claim 5, further characterized in that said solid delivery form includes a proximal end, a distal end, and a central hole disposed in said distal end.

8. The composition according to claim 7, further characterized in that it comprises a handle, said handle being adapted to be operatively connected to said form of supply.

9. The composition according to claim 8, further characterized in that said handle is threaded.

10. The composition according to claim 5, further characterized in that said active pharmaceutical ingredient is selected from the group consisting of analgesics, anti-allergy medications, anti-asthma medications, antibiotics, antiviral drugs, antifungal drugs, anticholinergics, anticonvulsants, antidepressants, antihistamines, antiemetics, antiepileptics, antispasmodics, aminophylline, ascorbic acid, aspirin, acetaminophen, barbiturates, benzodiazepines, bisacodyl, butyrophenones, caffeine, doral hydrate, chloropromazine, clindamycin, clotrimazole, codeine, corticosteroids, dextromethorphan, diazepam, dinoprostone, diphenhydramine , ergotamine, estrogens, fentanyl, ferrous sulfate, guaifenesin, haloperidol, hormone supplements, hydromorphone, indomethacin, kaolin, pectin, laxatives, lithium, loperamide, meclizine, meprobamate, methadone, metronidazole, miconazole, morphine, NSAIDs, opioids, orphenadrine, oxymorphone , pentobarbital, phenobarbital, phenothiazines, phenytoin, prochlorperazine, progestins, promethazine, ritalin, simethicone, spiramycin, sulfonamides, theophylline, trimethobenzamide, valproic acid and vitamins.

11. The composition according to claim 4, further characterized in that said non-solid delivery form is selected from the group consisting of a gel, a liquid, a paste and a foam.

12. The composition according to claim 11, further characterized in that said active pharmaceutical ingredient is selected from the group consisting of analgesics, anti-allergy medications, anti-asthma medications, antibiotics, antiviral drugs, antifungal drugs, anticholinergic, anticonvulsants, antidepressants, antihistamines, antiemetics, antiepileptics, antispasmodics, aminophylline, ascorbic acid, aspirin, acetaminophen, barbiturates, benzodiazepines, bisacodyl, butyrophenones, caffeine, doral hydrate, chloropromazine, clindamycin, clotrimazole, codeine, corticosteroids, dextromethorphan, diazepam, dinoprostone, diphenhydramine, ergotamine, estrogen, fentanyl, ferrous sulfate, guaifenesin, haloperidol, hormone supplements, hydromorphone, indomethacin, kaolin, pectin, laxatives, lithium, loperamide, meclizine, meprobamate, methadone, metronidazole, miconazole, morphine, NSAIDs, opioids, orphenadrine, oxymorphone, pentobarbital, phenobarbital, phenothiazines, phenytoin, prochlorperazine, progestins, promethazine, ritalin, simethicone, spiramycin, sulfonamides, theophylline, trimethobenzamide, valproic acid and vitamins.

13. The composition according to claim 11, further characterized in that it comprises an applicator adapted to facilitate the administration of said physiologically acceptable formulation, which includes said active pharmaceutical ingredient to the oral and rectal cavity.

14. The composition according to claim 11, further characterized in that it comprises the addition of ingredients that promote adhesiveness to the oral and rectal mucosa.

15. The composition according to claim 13, further characterized in that said applicator includes a supply component.

16. The composition according to claim 15, further characterized in that said supply component is selected from the group consisting of a plunger and a squeezable component.

17. - The composition according to claim 1, further characterized in that said physiologically acceptable formulation further includes a base component, and wherein said base component is selected from the group consisting of glycerinated gelatin, polyethylene glycol and MBK fatty acid.

18. The composition according to claim 1, further characterized in that it comprises at least one excipient ingredient.

19. The composition according to claim 18, further characterized in that said excipient ingredient (at least one) is selected from the group consisting of mannitol, dextrose, lactose, sucrose and calcium carbonate.

20. The composition according to claim 5, further characterized in that it comprises an incision mark disposed on a surface of said delivery form.

21. The composition according to claim 20, further characterized in that said incision mark is disposed on said surface at a site that reflects the absorption regime of said active pharmaceutical ingredient (at least one) in the oral cavity, intestine or rectum of the patient's body.

22. The composition according to claim 4, further characterized in that a solid or non-solid composition is enclosed in a capsule that can be swallowed or inserted rectally.

23. - The composition according to claim 1, further characterized in that said form of supply is also alternatively administrable to the body of a patient through a nasal administration route.

24. The use of a composition comprising a physiologically acceptable formulation that includes at least one active pharmaceutical ingredient, for preparing a single unit delivery form that is administrable to the body of a patient through a plurality of administration routes; including oral or rectal administration routes; to treat a disease or condition.

25. The use claimed in claim 24, wherein said oral administration route is selected from the group consisting of an oral transmucosal route and an oral gastrointestinal route.

26. The use claimed in claim 25, wherein said rectal administration route further comprises a rectal transmucosal route.

27. The use claimed in claim 26, wherein said form of supply is selected from the group consisting of a solid and a non-solid.

28. The use claimed in claim 27, wherein said solid delivery form is selected from the group consisting of a suppository, a pill, a swallowable tablet, a chewable tablet and a dissolvable tablet.

29. The use claimed in claim 28, wherein said solid delivery form is a suppository, and said composition is administrable by means of said rectal administration route.

30. The use claimed in claim 28, wherein said solid delivery form is a suppository, and further comprises adapting said form of delivery to be administrable by means of said oral administration route.

31. The use claimed in claim 30, wherein said solid delivery form includes a proximal end, a distal end, and a central hole disposed in said distal end.

32. The use claimed in claim 31, wherein it comprises a handle, wherein the method further comprises operatively connecting said handle to said supply form.

33. The use claimed in claim 32, wherein said handle is threaded and said hole is additionally threaded, and the operative connection of said handle to said form of supply includes carrying said handle in receiving relation with said hole, and rotating said handle with respect to said form of supply.

34. The use claimed in claim 27, wherein said non-solid delivery form is selected from the group consisting of a gel, a liquid, a paste and a foam.

35.- The use claimed in claim 34, further comprising an applicator.

36. - The use claimed in claim 28, wherein said solid supply form further comprises an incision mark disposed on a surface of said delivery form, the location of said incision mark reflecting the total dose delivered and the rate of delivery. absorption of said pharmaceutical ingredient (at least one) in the patient's body.

37. The use claimed in claim 36, wherein said solid delivery form is administrable intact to one of said oral or rectal administration routes. 38.- The use claimed in claim 37, further comprising breaking said solid supply form along said incision mark in first and second portions.