WO2007062262A2

WO2007062262A2 - Gelatinous medicament formulation and method of administration

Info

Publication number: WO2007062262A2
Application number: PCT/US2006/045585
Authority: WO
Inventors: Philip Y. Braginsky; Barry J. Marenberg
Original assignee: Braginsky Philip Y; Marenberg Barry J
Priority date: 2005-11-28
Filing date: 2006-11-28
Publication date: 2007-05-31
Also published as: WO2007062262A3

Abstract

Gelatinous compositions are provided which comprise a gelatin or gelatin-like component, water, and one or more active agents, which are advantageously pharmaceuticals, medicaments and/or vitamins and nutrients. The composition of the present invention facilitates the oral ingestion of one or more active agents, such as a therapeutic agent or pharmaceutical, by including the active agent in a gelatinous suspension which can be easily swallowed as a result of its soft, smooth consistency. Methods of making, administering and dispensing are also disclosed.

Description

GELATINOUS MEDICAMENT FORMULATION AND METHOD OF ADMINISTRATION

FIELD OF THE INVENTION

The present invention relates to pharmaceuticals. More particularly, the invention relates to a gelatinous composition including an active agent and which facilitates administration to a patient in need of the active agent.

BACKGROUND

Drugs are introduced into the body by several routes. They may be taken by mouth (orally); given by injection into a vein (intravenously), into a muscle (intramuscularly), into the space around the spinal cord (intrathecally), or beneath the skin (subcutaneously); placed under the tongue (sublingually); inserted in the rectum (rectally) or vagina (vaginally); instilled in the eye (by the ocular route); sprayed into the nose and absorbed through the nasal membranes (nasally); breathed into the lungs, usually through the mouth (by inhalation); applied to the skin (cutaneously) for a local (topical) or bodywide (systemic) effect; or delivered through the skin by a patch (transdermally) for a systemic effect. Each route has specific purposes, advantages, and disadvantages. Because the oral route is the most convenient and usually the safest and least expensive, it is the one most often used.

The oral route is, however, not always the easiest route of administration. Children and elderly people very often have difficulty ingesting medicine that they are required to take for one or more conditions. These children or elderly people may be unable to chew solid dosage forms, or they may be unable to swallow liquid pharmaceuticals because of poor taste, amongst other reasons. Oftentimes, parents and/or caretakers attempt to facilitate the ingestion of the necessary drugs by "hiding" them, either whole or by crushing the pills, within foods such as peanut butter, pudding, apple sauce, etc. Compounding pharmacists often attempt to change the flavor of poorly tasting liquid pharmaceuticals to make them more palatable. SUMMARY OF THE INVENTION

The invention provides a gelatinous composition comprising gelatin, water, a sweetening agent; and one or more active agents.

The composition of the present invention facilitates the oral ingestion of one or more active agents, such as a therapeutic agent or pharmaceutical, by including the active agent in a gelatinous suspension which can be easily swallowed as a result of its soft, smooth consistency. Typically gelatin is easily ingested since minimal chewing is required. Additionally, gelatin can be flavored so as to be pleasing and palatable to the person ingesting it. In view of these features, the present invention provides for a gelatinous suspension which includes one or more active agents in therapeutically effective dosages to be administered to a patient in need thereof.

The above and other features of the invention, including various novel details of construction and combinations of parts, will now be more particularly described with reference to the accompanying drawings and pointed out in the claims. It will be understood that the particular device embodying the invention is shown by way of illustration only and not as a limitation of the invention. The principles and features of this invention may be employed in various and numerous embodiments without departing from the scope of the invention.

BRIEF DESCRIPTION OF THE FIGURES

These and other features, aspects, and advantages of the apparatus and methods of the present invention will become better understood with regard to the following description, appended claims, and accompanying drawing in which:

Fig. 1 illustrates a single-serving dosage of the gelatinous medicament formulation of the present invention.

DETAILED DESCRIPTION Gelatin is a protein product derived through partial hydrolysis of the collagen extracted from skin, bones, cartilage, ligaments, etc. The natural molecular bonds between individual collagen strands are broken down into a form that rearranges more easily. Gelatin melts when heated and solidifies when cooled again. Together with water it forms a semi-solid colloidal gel.

Gelatin is a heterogeneous mixture of single or multi-stranded polypeptides, each with extended left-handed proline helix conformations and containing between 300 - 4000 amino acids. The triple helix of type I collagen extracted from skin and bones, as a source for gelatin, is composed of two al(I) and one a2(I) chains, each with molecular mass ~95 kD, width ~1.5 run and length ~0.3 mm. Gelatin consists of mixtures of these strands together with their oligomers and breakdown (and other) polypeptides. Solutions undergo coil-helix transition followed by aggregation of the helices by the formation of collagen-like right-handed triple-helical proline/hydroxyproline rich junction zones. Higher levels of these pyrrolidines result in stronger gels. Each of the three strands in the triple helix require 25 residues to complete one turn; typically there would be between one and two turns per junction zone. Gelatin films containing greater triple-helix content swell less in water and are consequentially much stronger. Chemical cross-links can be introduced, to alter the gel properties, using transglutaminase to link lysine to glutamine residues or by use of glutaraldehyde to link lysine to lysine.

There are two types of gelatin dependent on whether or not the preparation involves an alkaline pretreatment, which converts asparagine and glutamine residues to their respective acids and results in higher viscosity. Acid pretreatment (Type A gelatin) utilizes pigskin whereas alkaline treatment (Type B gelatin) makes use of cattle hides and bones.

Gelatin is primarily used as a gelling agent forming transparent elastic thermoreversible gels on cooling below about 35°C, which dissolve at low temperature to give 'melt in the mouth' products with useful flavor-release. In addition, the amphiphilic nature of the molecules endows them with useful emulsification (e.g. whipped cream) and foam-stabilizing properties (e.g. mallow foam). On dehydration, irreversible conformational changes take place that may be utilized in the formation of surface films. Such films are strongest when they contain greater triple-helix content. Gelatin is also used as a fining agent to clarify wine and fruit juice.

When heated water (advantageously at or near boiling point) is added to gelatin powder, the energy of the heated water is enough to break up the weak bonds holding the gelatin strands together. The helical structure falls apart, and you are left with free polypeptide chains floating about in solution. When the mixture is cooled down, the polypeptide chains begin to reassociate and reform the tight triple helix structure. However, the chilling process is slow, and the individual strands have been widely dispersed by mixing, so the helices aren't perfectly formed. In some places, there are gaps in the helix, and in others, there is just a tangled web of polypeptide chains. When the gelatin solution is chilled, water is trapped inside these gaps and pockets between chains. The protein net that is left after chilling gives the gelatin mold its shape, and the trapped water.

In the colloidal semi-solid (soft) gel form, gelatin provides a unique vehicle for the administration of many various therapeutically active agents, particularly to patients who are unable to ingest solid dosage forms or liquid pharmaceuticals. Since vegetarians and vegans do not eat gelatin made from the bones and skin of animals, the present invention also contemplates vegan forms of gelatin, which is typically made from alginates, agar-agar, xanthan and guar gum, carageenan, amongst other non- animal derived products.

There are no particular restrictions on the active agent to be formulated within the colloidal semi-solid gel form provided it can be administered orally. A non- exhaustive, non-limiting list of such drugs include: (1) antipyretics, analgesics and antiphlogistics (such as indomethacin, aspirin, diclofenac sodium, ketoprofen, ibuprofen, mefenamic acid, azulene, phenacetin, isopropyl antipyrine, acetaminophen, benzadac, phenylbutazone, fiufenamic acid, sodium salicylate, salicylamide, sazapyrine and etodolac), (2) steroid anti-inflammatory drugs (such as dexamethasone, hydrocortisone, prednisolone and triamcinolone), (3) antiulcer drugs (such as ecabet sodium, enprostil, sulpiride, cetraxate hydrochloride, gefarnate, irsogladine maleate, cimetidine, ranitidine hydrochloride, famotidine, nizatidine and roxatidine acetate hydrochloride), (4) coronary vasodilators (such as nifedipine, isosorbide dinitrate, diltiazem hydrochloride, trapidil, dipyridamole, dilazep hydrochloride, verapamil, nicardipine, nicardipine hydrochloride and verapamil hydrochloride), (5) peripheral vasodilators (such as ifenprodil tartrate, cinepacide maleate, ciclandelate, cynnaridine and pentoxyfylline), (6) antibiotics (such as ampicillin, amoxicillin, cefalexin, erythromycin ethyl succinate, bacampicillin hydrochloride, minocycline hydrochloride, chloramphenicol, tetracycline, erythromycin, ceftazidime, cefuroxime sodium, aspoxicillin and ritipenem acoxyl hydrate), (7) synthetic antimicrobials (such as nalidixic acid, piromidic acid, pipemidic acid trihydrate, enoxacin, cinoxacin, ofloxacin, norfloxacin, ciprofloxacin hydrochloride and sulfamethoxazole-trimethoprim), (8) antiviral agents (such as aciclovir and ganciclovir), (9) anticonvulsants (such as propantheline bromide, atropine sulfate, oxitropium bromide, timepidium bromide, scopolamine butylbromide, trospium chloride, butropium bromide, N- methylscopolamine methylsulfate and methyloctatropine bromide), (10) antitussives (such as tipepidine hibenzate, methylephedrine hydrochloride, codeine phosphate, tranilast, dextromethorphan hydrobromide, dimemorfan phosphate, clofenadol hydrochloride, fominoben hydrochloride, benproperine phosphate, eprazinone hydrochloride, clofedanol hydrochloride, ephedrine hydrochloride, noscapine, pentoxyverine citrate, oxeladin citrate and isoaminyl citrate), (11) expectorants (such as bromhexine hydrochloride, carbocysteine, ethyl cysteine hydrochloride, guaifensesin and methylcysteine hydrochloride), (12) bronchodilators (such as theophylline, aminophylline, sodium cromoglicate, procaterol hydrochloride, trimetoquinol hydrochloride, diprophylline, salbutamol sulfate, clorprenaline hydrochloride, formoterol fumarate, orciprenaline sulfate, pirbuterol hydrochloride, hexoprenaline sulfate, bitolterol mesilate, clenbuterol hydrochloride, terbutaline sulfate, mabuterol hydrochloride, fenoterol hydrobromide and methoxyphenamine hydrochloride), (13) cardiacs (such as dopamine hydrochloride, dobutamine hydrochloride, docarpamine, denopamine, caffeine, digoxin, digitoxin and ubidecarenone), (14) diuretics (such as furosemide, acetazolamide, trichlormethiazide, methylclothiazide, hydrochlorothiazide, hydroflumethiazide, ethiazide, cyclopenthiazide, spironolactone, triamterene, florothiazide, piretanide, mefruside, etacrynic acid, azosemide and clofenamide), (15) muscle relaxants (such as chlorphenesin carbamate, tolperisone hydrochloride, eperisone hydrochloride, tizanidine hydrochloride, mephenesine, chlorzoxazone, phenprobamate, methocarbamol, chlormezanone, pridinol mesilate, afloqualone, baclofen and dantrolene sodium), (16) cerebral metabolism ameliorants (such as nicergoline, meclofenoxate hydrochloride and taltireline), (17) minor tranquilizers (such as oxazolam, diazepam, clotiazepam, medazepam, temazepam, fludiazepam, meprobamate, nitrazepam and chlordiazepoxide), (18) major tranquilizers (such as sulpiride, clocapramine hydrochloride, zotepine, chlorpromazine and haloperidol), (19) /3-blockers (such as bisoprolol fumarate, pindolol, propranolol hydrochloride, carteolol hydrochloride, metoprolol tartrate, labetanol hydrochloride, acebutolol hydrochloride, bufetolol hydrochloride, alprenolol hydrochloride, arotinolol hydrochloride, oxprenolol hydrochloride, nadolol, bucumolol hydrochloride, indenolol hydrochloride, timolol maleate, befunolol hydrochloride and bupranolol hydrochloride), (20) antiarrthymics (such as procainamide hydrochloride, disopyramide phosphate, cibenzoline succinate, ajmaline, quinidine sulfate, aprindine hydrochloride, propafenone hydrochloride, mexiletine hydrochloride and ajmilide hydrochloride), (21) athrifuges (such as allopurinol, probenicid, colistin, sulfinpyrazone, benzbromarone and bucolome), (22) anticoagulants (such as ticlopidine hydrochloride, dicumarol, potassium warfarin, and (2R,3R)-3-acetoxy-5-[2(dimethylamino)ethyl]-2 ,3-dihydro-8-methyl-2-( 4- ethylphenyl)-l,5-benzothiazepine-4(5H)-one maleate), (23) thrombolytics (such as methyl(2E,3Z)-3-benzylidene-4-(3,5-dimethoxy-Q!-methyl benzylidene)-N-(4- methylpiperazin-l-yl)succinamate hydrochloride), (24) liver disease drugs (such as (.+- .)r-5-hydroxymethyl-t-7-(3,4-dimethoxyphenyl)-4-oxo-4,5,6,7-tetrahydro benzo [bjfuran-c-β-carboxylactone), (25) antiepileptics (such as phenytoin, sodium valproate, metalbital and carbamazepine), (26) antihistamines (such as chlorpheniramine maleate, clemastine fumarate, mequitazine, alimemazine tartrate, cyproheptadine hydrochloride and bepotastin besilate), (27) antiemitics (such as difenidol hydrochloride, metoclopramide, domperidone and betahistine mesilate and trimebutine maleate), (28) depressors (such as dimethylaminoethyl reserpilinate dihydrochloride, rescinnamine, methyldopa, prazocin hydrochloride, bunazosin hydrochloride, clonidine hydrochloride, budralazine, urapidil and N-[6-[2-[(5-bromo-2-pyrimidinyl)oxy] ethoxy]-5-(4- methylphenyl)-4-pyrimidinyl] -4-(2-hydroxy- 1 , 1 -dimethylethyl)b enzene sulfonamide sodium), (29) hyperlipidemia agents (such as pravastatin sodium and fluvastatin sodium), (30) sympathetic nervous stimulants (such as dihydroergotamine mesilate and isoproterenol hydrochloride, etilefrine hydrochloride), (31) oral diabetes therapeutic drugs (such as glibenclamide, tolbutamide and glymidine sodium), (32) oral carcinostatics such as marimastat), (33) alkaloid narcotics (such as orphine, codeine and cocaine), (34) vitamins, minerals and nutrients (such as vitamin Bl, vitamin B2, vitamin B6, vitamin B 12, vitamin C, vitamin E and folic acid), (35) thamuria therapeutic drugs (such as flavoxate hydrochloride, oxybutynin hydrochloride and terolidine hydrochloride), (36) angiotensin convertase inhibitors (such as imidapril hydrochloride, enalapril maleate, alacepril and delapril hydrochloride), (37) electrolytes (such as potassium and sodium, and (38) amino acids (such as L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-glutamic acid, L-glycine, L-histidine, L- isoleucine, L-leucine, L- lysine, L-methionine, L-ornithine, L-carnithine, L-phenylalanine, L-proline, Lserine, L- threonine, L-tryptophan, L-tyrosine, and L- valine).

It is appreciated that certain active agents or vitamins/nutrients for incorporation into the gelatinous composition may be insoluble in water (e.g., a lipid). In such cases, the active ingredients are solubilized using known solubilization processes or by incorporation into liposomes, micelles or cyclodextrins.

In one or more embodiments, additives such as additional sweeteners and flavoring components may be added to the composition to adjust the taste. Additionally coloring agents may be incorporated to change the appearance of the composition. Preset amounts of these additives are typically thoroughly mixed into the powdered gelatin The therapeutic (active) agent used in the formulation of the present invention maybe liquid or solid. If liquid, the agent is mixed with water and added to the gelatin powder. A therapeutic agent in solid form is advantageously ground up to a fine powder which is combined with the gelatin powder and to which water is added. Upon the addition of water to the powder, a suspension is formed within which the active agent is maintained. In another embodiment the solid agent may be lyophilized and reconstituted at the appropriate time.

According to an embodiment of the present invention, the composition of the present invention can be made in a large batch and then cut into proper dosage portions. Alternatively, molds can be utilized which shape the composition for a single-serving dosage. The single-serving dosage may also be prepared in disposable cups or may be prepared in batch form and transferred to single-dosage sized cups. Fig. 1 illustrates one embodiment of a single-serving dosage of the formulation according to the present invention. In Fig. 1 single-serving dosage 10 includes the semi-solid colloidal gel 12 including a medicament. The dosage 10 in the embodiment illustrated in Fig. 1 is contained in a plastic container 14 which is disposable. Container 10 may also be provided with a lid 16. An empty container 10 and lid 16 are also illustrated in Fig. 1. While the container 10 illustrated in Fig. 1 is plastic, the invention is not limited in this regard and other containers are contemplated such as, but not limited to, paper containers and cups.

The method of dispensing the present invention may take any known embodiment. This includes, but is not limited to, the method comprising the steps of placing a single dosage of the gelatinous composition into a container and dispensing the container for administration of the gelatinous composition. Additionally, the method of dispensing the gelatinous medicament composition may comprise the steps of placing one or more dosages of the gelatinous composition into a container and dispensing the container for administration of the gelatinous composition.

Of course the administration of the gelatinous medicament is by known methods. The method may comprise the step of ingesting a dose of a medicament composition in a gelatinous form. The gelatinous form may comprise a gelatin or gelatin-like component, water; and one or more active agents.

It is also contemplated to provide the composition as part of a kit which includes the gelatin ingredients, the active agent and may include an apparatus which heats the mixture and then cools the mixture in accordance with the preparation directions as discussed above. Containers having integral heating and cooling modules, such as those described by Scudder, et al. in U.S. Pat. Nos. 5,461,867 and 5, 626,022, may be utilized in preparing the gelatinous composition of the present invention. A self-contained vessel which mixes calcium oxide (quicklime) and water to provide heat is known in the art. Such a vessel could be utilized to heat the gelatin mixture which may then be cooled via an additional cooling feature or any other any other cooling mechanism such as refrigeration, dry ice and the like.

In another embodiment, the gelatinous composition of the present invention may be freeze-dried and sealed in such a manner to provide extended shelf life. Additionally, although the gelatinous composition is advantageously prepared by adding heated water to gelatin powder, it is possible that water at room temperature could be utilized and an enzyme or other chemical or mechanical apparatus can be added to elevate the mixture temperature or increase the pressure.

In an additional embodiment, the composition may be maintained in liquid form and then rapid cooled to solidify into gelatinous form, hi this regard, the liquid form could be maintained in bulk and various different combinations of medicaments and/or vitamins can be quickly selected, formulated and added to the liquid to be rapidly cooled into the gelatinous soft-gel form.

The present invention also encompasses a method of administering the gelatinous medicament formulation, hi one embodiment in which a single-dosage serving of the gelatinous medicament formulation is contained in a cup, the patient simply brings the cup to his or her mouth and squeezes the bottom of the cup or tips the cup. The pressure or gravity applied on the bottom of the cup cause the semi-solid gel to move from the cup into the patient's mouth where it may partially liquefy and is easily ingested. Alternatively, a patient could use a spoon to ingest the gel in piecemeal fashion.

In accordance with the present invention, a medicament will be formulated within a gelatin matrix for administration and ingestion by a patient. It is contemplated that the present invention will facilitate the ingestion of medicine by young children and older patients who have problems swallowing solid dosage forms or poor tasting liquid medicines.

EXAMPLES Example 1 Making a Gelatin Mold

To make a gelatin mold, powdered gelatin is placed in a bowl to which heated water (at or near boiling point) is added to the powdered gelatin. The mixture is then stirred for approximately 3 minutes until the gelatin dissolves completely. Next cold water is added to the mixture and the mixture is refrigerated for several hours until it congeals. In one embodiment, the mixture may be poured into a mold.

Example 2

Making a Gelatin/Pharmaceutical Suspension

When the desired pharmaceutical is a liquid, the desired therapeutic amount is combined with the water that is added to the powdered gelatin. If the desired pharmaceutical is a solid, it is typically finely ground to a powder and combined with the gelatin powder prior to the addition of the water. Alternatively, the finely ground pharmaceutical may be added to the mixture after the water has been added to the gelatin powder.

While there has been shown and described what is considered to be preferred embodiments of the invention, it will, of course, be understood that various modifications and changes in form or detail could readily be made without departing from the spirit of the invention. It is therefore intended that the invention be not limited to the exact forms described and illustrated, but should be constructed to cover all modifications that may fall within the scope of the appended claims.

Claims

CLAIMSWhat is claimed is:

1. A gelatinous medicament composition comprising: a. a gelatin or gelatin-like component; b. water; and c. one or more active agents.

2. The composition as recited in claim 1, wherein said active agent is a medicament.

3. The composition as recited in claim 2, wherein said medicament is a liquid.

4. The composition as recited in claim 2, wherein said medicament is a finely ground solid dosage form.

5. The composition as recited in claim 2, wherein said medicament may be selected from the group consisting of anti-inflammatory agents, antitumor agents, anti-tussive agents, antibiotics, antivirals, anti-arthritic agents, anti-cancer agents, anti-depression agents, anti-psychotic agents, anti-anxiety agents, anti-thrombotic agents, anti-asthmatic agents, antipyretics, analgesics, immunosuppressive agents, immunoactive agents, neuroleptic agents, anxiolytic agents, anticonvulsant agents, anticholinergic agents, antifungal agents, antiulcer agents, anticonvulsant agents, expectorants, diuretics, muscle relaxants, minor tranquilizers and anesthetics, /3-blockers, antiarrthymics, anticoagulants, antiepileptics, antihistamines, antiemitics, and the like.

6. The composition as recited in claim 1 , wherein said active agents comprise one or more vitamins, minerals and/or nutrients.

7. The composition as recited in claim 1, further comprising a flavoring component.

8. The composition as recited in claim 1, further comprising a sweetening component.

9. The composition as recited in claim 8 wherein the sweetening component is a sugar.

10. The composition as recited in claim 1, wherein said gelatin-like component may comprise alginates, agar-agar, xanthan and guar gum, carageenan, an other non-animal derived products.

11. A method for preparing a gelatinous medicament composition, the method comprising the steps of: a. adding a gelatin mixture to a recepticle; b. adding one or more active agents to said recepticle; c. pouring boiling water into said recepticle; d. stirring said mixture until all ingredients are dispersed; e. cooling said mixture until said mixture congeals.

12. The method for preparing a gelatinous medicament composition as in claim 11 further comprising: adding a sweetening component as an ingredient.

13. The method for preparing a gelatinous medicament composition as in claim 12 wherein the sweetening component is a sugar.

14. The method for preparing a gelatinous medicament composition as in claim 11 wherein said active agents may be selected from the group consisting of anti-inflammatory agents, anti-tumor agents, anti-tussive agents, antibiotics, antivirals, anti-arthritic agents, anti-cancer agents, anti-depression agents, anti-psychotic agents, anti-anxiety agents, antithrombotic agents, anti-asthmatic agents, antipyretics, analgesics, immunosuppressive agents, immunoactive agents, neuroleptic agents, anxiolytic agents, anticonvulsant agents, anticholinergic agents, antifungal agents, antiulcer agents, anticonvulsant agents, expectorants, diuretics, muscle relaxants, minor tranquilizers and anesthetics, β- blockers, antiarrthymics, anticoagulants, antiepileptics, antihistamines, antiemitics, and the like.

15. The method for preparing a gelatinous medicament composition as in claim 11 , wherein said active agents comprise one or more vitamins, minerals and/or nutrients.

16. A method for preparing a gelatinous medicament composition, the method comprising the steps of: a. adding a gelatin mixture to a recepticle; b. adding one or more active agents to said recepticle; c. adding a liquid ingredient to said recepticle; d. transferring heat to said recepticle; e. stirring said mixture until all ingredients are dispersed; f. cooling said mixture until said mixture congeals.

17. The method for preparing a gelatinous medicament composition as in claim 16 wherein said active agents maybe selected from the group consisting of anti-inflammatory agents, anti-tumor agents, anti-tussive agents, antibiotics, antivirals, anti-arthritic agents, anti-cancer agents, anti-depression agents, anti-psychotic agents, anti-anxiety agents, antithrombotic agents, anti-asthmatic agents, antipyretics, analgesics, immunosuppressive agents, immunoactive agents, neuroleptic agents, anxiolytic agents, anticonvulsant agents, anticholinergic agents, antifungal agents, antiulcer agents, anticonvulsant agents, expectorants, diuretics, muscle relaxants, minor tranquilizers and anesthetics, β- blockers, antiarrthymics, anticoagulants, antiepileptics, antihistamines, antiemitics, and the like.

18. The method for preparing a gelatinous medicament composition as in claim 16, wherein said active agents comprise one or more vitamins, minerals and/or nutrients.

19. A method of dispensing a gelatinous medicament composition, the method comprising the steps of: a. placing a single dosage of the gelatinous medicament composition into a container; b. dispensing the container for administration of the gelatinous composition.

20. The method of dispensing a gelatinous medicament composition as in claim 15 wherein: a. the gelatinous medicament composition comprises a gelatin or gelatin-like component, water, and one or more active agents.

21. The method of dispensing a gelatinous medicament composition as in claim 20 wherein said active agents may be selected from the group consisting of anti-inflammatory agents, anti-tumor agents, anti-tussive agents, antibiotics, antivirals, anti-arthritic agents, anti-cancer agents, anti-depression agents, anti-psychotic agents, anti-anxiety agents, antithrombotic agents, anti-asthmatic agents, antipyretics, analgesics, immunosuppressive agents, immunoactive agents, neuroleptic agents, anxiolytic agents, anticonvulsant agents, anticholinergic agents, antifungal agents, antiulcer agents, anticonvulsant agents, expectorants, diuretics, muscle relaxants, minor tranquilizers and anesthetics, β- blockers, antiarrthymics, anticoagulants, antiepileptics, antihistamines, antiemitics, and the like.

22. The method of dispensing a gelatinous medicament composition as in claim 20, wherein said active agents comprise one or more vitamins, minerals and/or nutrients.

23. A method of dispensing a gelatinous medicament composition, the method comprising the steps of: a. placing one or more dosages of the gelatinous composition into a container; b. dispensing the container for administration of the gelatinous composition.

24. A method of administering a medicament composition, the method comprising the step of ingesting a dose of a medicament composition in a gelatinous form.

25. The method of administering a medicament composition as in claim 24 wherein the gelatinous form comprises a gelatin or gelatin-like component, water; and one or more active agents.

26. The method of administering a medicment composition as in claim 25, wherein said active agents may be selected from the group consisting of anti-inflammatory agents, anti-tumor agents, anti-tussive agents, antibiotics, antivirals, anti-arthritic agents, anti-cancer agents, anti- depression agents, anti-psychotic agents, anti-anxiety agents, antithrombotic agents, anti-asthmatic agents, antipyretics, analgesics, immunosuppressive agents, immunoactive agents, neuroleptic agents, anxiolytic agents, anticonvulsant agents, anticholinergic agents, antifungal agents, antiulcer agents, anticonvulsant agents, expectorants, diuretics, muscle relaxants, minor tranquilizers and anesthetics, β- blockers, antiarrthymics, anticoagulants, antiepileptics, antihistamines, antiemitics, and the like.

27. The method of administering a medicment composition as in claim 25, wherein said active agents comprise one or more vitamins, minerals and/or nutrients.