PECTIN GUMMY COMPOSTION AND METHODS OF MAKING AND USING THEREOF

Abstract

A method of making a gummy composition, comprising providing a gelling blend, comprising pectin having a carboxyl content of not more than 45% by weight of pectin and an amide content of not less than 20% by weight of pectin, a solubilizing blend, a swelling solvent and optionally a first bonding blend; optionally providing an emulsifying blend; optionally providing a second bonding blend, wherein the first bonding blend and the second bonding form a bonding blend; optionally providing an active blend, comprising an active agent; combining the gelling blend, the surfactant blend, the bonding blend and the active blend to provide a pre-molding blend, combing the pre-molding blend with a pH adjusting blend to provide a molding blend, wherein the molding blend has a pH value at least about 5; and forming the molding blend into a gummy composition.

Claims

1. A method of making a gummy composition, comprising providing a gelling blend, comprising pectin having a carboxyl content of not more than 45% by weight of pectin and an amide content of not less than 20% more than 25% by weight of pectin; a solubilizing blend, wherein the solubilizing blend comprises a solubilizing salt having a formula of M-A, wherein M represent a cation of an alkaline or alkaline earth metal and A represent an anion of a multivalent acid having at least one pKa exceeding about 4; a swelling solvent; and optionally a first bonding blend, optionally providing an emulsifying blend; optionally providing a second bonding blend, wherein the first bonding blend and the second bonding form a bonding blend; providing an active blend, comprising an active agent; combining the gelling blend, the emulsifying blend, the bonding blend and the active blend to provide a pre-molding blend; combining the pre-molding blend with a pH adjusting blend to provide a molding blend, wherein the molding blend has a pH value at least about 5; and forming the molding blend into a gummy dosage composition.

2. The method of claim 1, wherein the gelling blend comprises pectin having a carboxyl content of less than 40% by weight of pectin.

3. (canceled)

4. The method of claim 1, wherein the gelling blend comprises pectin having an amide content from about 30% to about 35% by weight of pectin.

5. The method of claim 1, wherein the gelling blend comprises pectin having a carboxyl content and an amide content, wherein the total of the carboxyl and the amide content is not from about 56% to about 70% by weight of pectin.

6. The method of claim 1, wherein the gelling blend comprises pectin having a carboxyl content not more than 39% and an amide content not less than 27% by weight of pectin.

7. The method of claim 1, wherein the swelling solvent comprises water, ethanol, glycerol, or a combination thereof.

8. The method of claim 1, wherein the bonding blend comprises tagatose, psicose, trehalose, isomaltulose, or a combination thereof.

9. The method of claim 1, wherein the solubilizing salt and the pectin are present in such a stoichiometric weight to weight ratio such that about of the carboxylic groups in pectin are configured to be deprotonated.

10. The gummy composition, comprising a gelling blend, optionally an emulsifying blend, a bonding blend and an active agent, wherein the gelling blend comprises pectin having a carboxyl content of not more than 45% by weight of pectin and an amide content of not less than 20% by weight of pectin.

11. The gummy composition of claim 10, wherein the gelling blend further comprises gelatin, wherein the collagen has a MW from about 10K to about 50K Dalton.

12. The gummy composition of claim 10, wherein the active agent comprises a penicillin, a cephalosporin, a macrolide, a fluroquinolone, a sulfonamide, a tetracycline, an aminoglycoside, or a combination thereof.

13. The gummy composition of claim 10, wherein the active agent comprises acetaminophen, aspirin, salicylic acid, ibuprofen, naproxen, diphenhydramine, scopolamine, metaformin, a PDE5 inhibitor, cetirizine, or a combination thereof.

14. The gummy composition of claim 10, wherein the active agent comprises cetirizine, diphenhydramine, loratadine, chlorpheniramine, brompheniramine, alimemazine, cyprohetadine, doxylamine, hydroxyzine, promethazine, or a combination thereof.

15. The gummy composition of claim 10, wherein the active agent guaifenesin, codeine phosphate, dextromethorphan hydrobromide, or a combination thereof.

16. The gummy composition of claim 10, wherein the active agent comprises dextromethorphan.

17. The gummy composition of claim 10, wherein the active agent comprises acamprosate, baclofen, buprenorphine, naloxone, clonidine, disulfiram, methadone, naltrexone, ondansetron, or a combination thereof.

18. The gummy composition of claim 10, wherein the active agent comprises nicotine, bupropion, cytosine, varenicline, or a combination thereof.

19. The gummy composition of claim 10, wherein the active agent comprises amphetamine, dexamfetamine, lisdexamfetamine, methylphenidate, dexmethylphenidate, metamfetamine, or a combination thereof.

20. The gummy composition of claim 10, wherein the active agent comprises citalopram, clomipramine, dexopin, escitalopram, fluoxetine, fluvoxamine, imipramine, mirtazapine, paroxetine, sertraline, trazodone, amitriptyline, doxepin, mianserin, mirtazapine, trazodone, trimipramine, or a combination thereof.

21. The gummy composition of 10, wherein the active agent comprises an aldosterone receptor antagonist, an angiotensin converting enzyme inhibitor, an angiotensin receptor blocker, a neprilysin inhibitor, an antiadrenergic agent, an antianginal agent, an antiarrhythmic agent, an anticholinergic chronotropic agent, an antihypertension agent, an ACE inhibitor, an angiotensin II inhibitor, an antiadrenergic agent, a beta blocker, a diuretic agent, a beta-adrenergic blocker, a calcium channel blocker, a catecholamine, an inotropic agent, a vasodilator, a renin inhibitor, a sclerosing agent, a vasopressin antagonist, a vasopressor, an anti-cholesterol agent, or a combination thereof.

22. A medication kid, comprising a gummy composition of claim 10 and an instruction for using such gummy composition for treating a disease.

Description

DETAILED DESCRIPTION

[0116] The gummy dosage form of the disclosure is intended to be chewed by a person such that it is broken up into smaller parts or melt within the oral cavity. The active agent may be released from the gummy dosage and absorbed efficiently through mucosal membrane into blood stream allowing a quick release and fast absorption of the active ingredient. In addition, the smaller pieces may be easily swallowed thereby providing an administration advantage over traditional tablets based dosage forms.

[0117] The gummy dosage form may have a sufficiently high viscosity that it is not pourable and further does not flow or conform to its container at room temperature. Typically, the gummy dosage form does not flow at low shear stress and generally exhibits plastic flow behavior. In general, the consistency of the gummy dosage form is the same as or similar to gelatin-based or pectin-based products.

[0118] The dosage form can have any size and shape such that it can be administered orally and chewed by a person. The person should be able to readily break apart the dosage form by chewing and swallow the dosage form without the need for an external source of liquid.

[0119] Typically, the dosage form has a length of about 1 cm to about 5 cm, width of about 1 cm to about 5 cm and a height of about 1 cm to about 5 cm. Suitable shapes include, for example, ovals, spheres, cylinders, hemisphere, hexagon, rectangular boxes, and cubes. The dosage form may be formed into unique shapes and figures including, for example, animals for administration to children (e.g., under the age of 13) and/or adults.

[0120] In one embodiment, each individual dosage form has a total weight of at least 100 mg. In some embodiments, each dosage form has a total weight of from about 1 g to about 20 g, each dosage form has a total weight of from about 1 g to about 15 g. each dosage form has a total weight of from about 1 g to about 10 g, for example, about 1 g to about 1.5 g, about 1.5 g to about 2 g, about 2 g to about 2.5 g, about 2.5 g to about 3 g, about 3.5 g to about 4 g, about 4 g to about 4.5 g, about 4.5 g to about 5 g, about 5 g to about 5.5 g, about 5.5 g to about 6 g, about 6 g to about 6.5 g, about 6.5 g to about 7 g, about 7 g to about 7.5 g, about 7.5 g to about 8 g, about 8 g to about 8.5 g, about 8.5 g to about 9 g, about 9 g to about 9.5 g, and about 9.5 g to about 10 g.

[0121] Each dosage form has a total weight of about 5 g.

[0122] Active agents that are suitable for use in the gummy dosage form for the disclosure include, by way of example, anti-allergy, antihistamines, antitussives, decongestants, expectorants, anti-cold/flu, analgesics, anti-inflammatories, sleep medications, anti-heartburn medications, anti-gas medications, anti-GERD medications, anti-diarrheas, laxatives, anti-smoking and/or motion sickness medications. In some embodiments, suitable active agents may treat and/or prevent gastrointestinal disorders including, for example, antacids, anti-foaming agents, H2 antagonists, proton pump inhibitors, anti-diarrheas, laxatives, or a combination thereof. Suitable active agents useful in the gummy dosage form of the disclosure are typically available as over-the-counter medications.

[0123] The gummy dosage of the disclosure is further useful for administration to individuals, including both adults and children, to treat and/or prevent allergies, colds and coughs, as well as symptoms of these conditions. Additionally, the gummy dosage form of the disclosure may be used to treat or prevent gastrointestinal disorders and symptoms thereof such as dyspepsia, peptic ulcer, gastroesophageal reflux disease, upset stomach, heartburn, excessive gas, and the like along with symptoms of these disorders.

[0124] In other embodiments, the gummy dosage form of the disclosure includes one or more active agents useful for the treatment of gastrointestinal disorders and symptoms thereof. Such active ingredients are typically available as over-the-counter medications.

[0125] Any suitable active agents may be used in the gummy dosage form of the present disclosure to treat or prevent one or more symptoms. Example active agents include without limitation, anti-allergy agents such as loratadine, diphenhydramine, cetirizine and fexofenadine; anti-cold or flu agents such as pseudoephedrine, phenylephrine and chlorpheniramine; analgesics such as ibuprofen, aspirin, naproxen, acetaminophen, and codeine; cough medications such as guaifenesin and dextromethorphan; sleep medications such as diphenhydramine and doxylamine; heartburn medications such as ranitidine, cimetidine, famotidine, omeprazole, esomeprazole, lansoprazole, calcium carbonate and bismuth subsalicylate; anti-diarrheas such as loperamide; anti-gas agents such as simethicone; laxatives such as bisacodyl; smoking cessation agents such as nicotine; motion sickness medications such as dimenhydrinate meclizine.

[0126] Combinations of two or more active agents may be used in the gummy dosage form of the disclosure to treat or prevent one or more symptoms. Suitable combinations of active agents include for example: anti-allergy combinations such as loratadine/pseudoephedrine, diphenhydramine/phenylephrine, diphenhydramine/pseudoephedrine, cetirizine/pseudoephedrine, and fexofenadine/pseudoephedrine; anti-cold and flu combinations such as chlorpheniramine/phenylephrine, ibuprofen/phenylephrine, dextromethorphan/ibuprofen/phenylephrine, dextromethorphan/acetaminophen/phenylephrine, acetaminophen/phenylephrine, acetaminophen/pseudoephedrine, doxylamine/dextromethorphan/acetaminophen, acetaminophen/dextromethorphan/guaifenesin/phenylephrine; analgesics combinations such as ibuprofen/caffeine, aspirin/caffeine, naproxen/caffeine, acetaminophen/caffeine, diphenhydramine/ibuprofen, diphenhydramine/acetaminophen, diphenhydramine/naproxen, acetaminophen/caffeine/aspirin; and antitussive combinations such as guaifenesin/dextromethorphan; sleep medication combinations such as diphenhydramine/ibuprofen, diphenhydramine/aspirin, diphenhydramine/naproxen, diphenhydramine/acetaminophen; anti-gas combination such as simethicone/calcium carbonate.

[0127] The active agents used in the gummy dosage form of the disclosure include chlorpheniramine maleate, phenylephrine hydrochloride, guaifenesin, dextromethorphan hydrobromide, loratadine, diphenhydramine, or a combination thereof. In one embodiment, the dosage form contains a combination of chlorpheniramine maleate and phenylephrine hydrochloride. In another embodiment, the dosage form contains a combination of dextromethorphan hydrobromide and phenylephrine hydrochloride. Chlorpheniramine maleate is a pharmaceutically acceptable salt of chlorpheniramine.

[0128] In some embodiments, the amount of chlorpheniramine maleate present in each dosage form is from about 0.1 mg to about 30 mg. The amount of chlorpheniramine maleate present in each dosage form is from about 1 mg to about 10 mg. The amount of chlorpheniramine maleate present in each dosage form is about 1 mg to about 5 mg. The amount of chlorpheniramine present is about 2 mg or about 4 mg in each dosage form that has a total weight of about 5 g.

[0129] Chlorpheniramine maleate may be present in the dosage form in amount from about 0.01% by weight to about 1.0% by weight, and about 0.02% to about 0.2% by weight. For an adult dose, chlorpheniramine maleate is present in an amount from about 0.06% by weight to about 0.1% by weight. For a pediatric dose (e.g., children under 13), chlorpheniramine maleate is present in an amount from about 0.03% by weight to about 0.05% by weight.

[0130] In some embodiments, the amount of phenylephrine hydrochloride present in each dosage form is from about 0.1 mg to about 20 mg. The amount of phenylephrine hydrochloride present is from about 2 mg to about 15 mg. The amount of phenylephrine hydrochloride present is from about 3 mg to about 12 mg. The amount of phenylephrine hydrochloride present is about 5 mg or about 10 mg in each dosage form that has a total weight of about 5 g.

[0131] Phenylephrine hydrochloride may be present in the dosage form in amount from about 0.01% by weight to about 1% by weight, and 0.01% to about 0.5% by weight. For an adult dose, phenylephrine hydrochloride is present in an amount from about 0.15% by weight to about 0.25% by weight. For a pediatric dose (e.g., children under 13), phenylephrine hydrochloride is present in an amount from about 0.05% by weight to about 0.15% by weight.

[0132] In some embodiments, the amount of guaifenesin present in each dosage form is from about 10 mg to about 1,500 mg. The amount of guaifenesin present in each dosage form is from about 200 mg to about 1,200 mg. The amount of guaifenesin present in each dosage form is about 100 mg to about 400 mg. The amount of guaifenesin present is about 100 mg, 200 mg or about 400 mg in each dosage form that has a total weight of about 5 g.

[0133] Guaifenesin may be present in the dosage form in amount from about 0.1% by weight to about 20% by weight, and about 0.5% to about 10% by weight. For an adult dose, guaifenesin is present in an amount from about 0.5% by weight to about 5% by weight. For a pediatric dose (e.g., children under 13), guaifenesin is present in an amount from about 0.1% by weight to about 4% by weight.

[0134] In some embodiments, the amount of dextromethorphan hydrobromide present in each dosage form is from about 1 mg to about 100 mg. The amount of guaifenesin present in each dosage form is from about 5 mg to about 60 mg. The amount of guaifenesin present in each dosage form is about 10 mg to about 30 mg. The amount of guaifenesin present is about 10 mg or about 20 mg in each dosage form that has a total weight of about 5 g.

[0135] Dextromethorphan hydrobromide may be present in the dosage form in amount from about 0.01% by weight to about 2% by weight, and about 0.1% to about 1% by weight. For an adult dose, guaifenesin is present in an amount from about 0.1% by weight to about 1% by weight. For a pediatric dose (e.g., children under 13), guaifenesin is present in an amount from about 0.1% by weight to about 0.8% by weight.

[0136] In some embodiments, the amount of loratadine present in each dosage form is from 1 mg to about 100 mg. The amount of loratadine present in each dosage form is from about 5 mg to about 50 mg. The amount of loratadine present in each dosage form is from about 10 mg to about 30 mg. The amount of loratadine present is about 10 mg in each dosage form that has a total weight of about 5 g.

[0137] Loratadine may be present in the dosage form in amount from about 0.01% by weight to about 2% by weight, and about 0.1% to about 1% by weight. For an adult dose, loratadine is present in an amount from about 0.1% by weight to about 1% by weight. For a pediatric dose (e.g., children under 13), loratadine is present in an amount from about 0.1% by weight to about 0.5% by weight.

[0138] In some embodiments, the amount of diphenhydramine hydrochloride present in each dosage form is from 1 mg to about 100 mg. The amount of diphenhydramine hydrochloride present in each dosage form is from about 5 mg to about 50 mg. The amount of diphenhydramine hydrochloride present in each dosage form is from about 10 mg to about 30 mg. The amount of diphenhydramine hydrochloride present is about 12.5 mg or 25 mg.

[0139] Diphenhydramine hydrochloride may be present in the dosage form in amount from about 0.01% by weight to about 2% by weight, and about 0.1% to about 1% by weight. For an adult dose, diphenhydramine hydrochloride is present in an amount from about 0.1% by weight to about 1% by weight. For a pediatric dose (e.g., children under 13), diphenhydramine hydrochloride is present in an amount from about 0.1% by weight to about 0.5% by weight.

[0140] Chlorpheniramine maleate and phenylephrine hydrochloride may optionally both be present in combination in the dosage form, in such embodiments, chlorpheniramine maleate is present in an amount of about 2 mg and phenylephrine hydrochloride is present in an amount of about 5 mg. In one embodiment, chlorpheniramine maleate is present in an amount of about 4 mg and phenylephrine hydrochloride is present in an amount of about 10 mg. Typically, a pediatric dose contains about 2 mg chlorpheniramine maleate and 5 mg phenylephrine hydrochloride and an adult dose contains about 4 mg chlorpheniramine maleate and 10 mg phenylephrine hydrochloride.

[0141] In embodiments, dextromethorphan hydrobromide and phenylephrine hydrochloride are both present in the dosage form. Dextromethorphan hydrobromide is present in an amount of about 10 mg and phenylephrine hydrochloride is present in an amount of about 5 mg.

[0142] Dextromethorphan hydrobromide is present in an amount of about 20 mg and phenylephrine hydrochloride is present in an amount of about 10 mg.

[0143] In other embodiments, the active agent is an antacid, anti-foaming agent, histamine H2-antagonist, proton pump inhibitor, anti-diarrheal, laxative, antibiotics, anti-fungal, anti-diabetes, anti-cancer, or combination thereof, that are useful for the treatment and/or prevention of gastrointestinal disorders or symptoms thereof.

[0144] Suitable antacids including, but are not limited to, potassium bicarbonate, sodium bicarbonate, calcium bicarbonate, aluminum bicarbonate, magnesium bicarbonate, magnesium hydroxide, calcium carbonate, aluminum hydroxide, and combinations thereof.

[0145] In one embodiment, the antacid is calcium carbonate. Calcium carbonate has the formula Ca2CO3. The calcium carbonate can be anhydrous calcium carbonate or a hydrate thereof.

[0146] Suitable histamine H2-receptor antagonists include, but are not limited to, cimetidine, ranitidine, famotidine, and nizatidine. In one embodiment, the histamine H2-receptor antagonist is famotidine. Suitable proton pump inhibitors include, but are not limited to, omeprazole, lansoprazole, dexlansoprazole, esomeprazole, pantoprazole, rabeprazole, and ilaprazole. In an embodiment, the proton pump inhibitor is omeprazole. A suitable anti-diarrheal includes, but is not limited to, loperamide. A suitable laxative includes, but is not limited to, bisacodyl. A suitable anti-gas agent includes, but is not limited to, simethicone.

[0147] The amount of active agent in the gummy dosage form will vary for each different active depending on its use. The amount present will usually be less for gummy dosage forms that are to be administered to children. For gummy dosage forms for use with gastrointestinal disorders, the active ingredient may be present in an amount sufficient to treat and/or prevent gastrointestinal disorders and symptoms thereof (e.g., bloating, discomfort and/or pain) including, for example, dyspepsia, peptic ulcer, gastroesophageal reflux disease, upset stomach, heartburn, and excessive gas. Typically, the gummy dosage form contains about 0.1 mg to 1 g of the active agent. In one embodiment, the gummy dosage form contains one or more active agents in an amount from about 0.01% by weight to about 10% by weight.

[0148] The gummy dosage form of the disclosure may be administered once per day or multiple times per day to provide relief for various symptoms affecting an individual. For example, chlorpheniramine maleate may be administered to treat symptoms of allergic rhinitis or sinusitis.

[0149] Phenylephrine hydrochloride may be administered to treat symptoms of nasal congestion.

[0150] Typical dosing of chlorpheniramine maleate for adults is 4 mg every 4-6 hours and for children (i.e., 6-11 years old) is 2 mg every 4-6 hours. Typical dosing of phenylephrine hydrochloride for adults is 10 mg every 4-6 hours and for children (i.e., 6-11 years old) is 5 mg every 4-6 hours.

[0151] Aspirin may be administered to treat symptoms of fever, pain or for cardiovascular health. Typical dosing of aspirin for adults is 81 mg for cardiovascular health and 325 mg for pain or fever relief and for children (i.e., 6-11 years old) is 81 mg.

[0152] Naproxen may be administered to relieve pain. Typical dosing of naproxen for adults is 275 mg to 500 mg and for children (i.e., 6-11 years old) is 250 mg or less.

[0153] Acetaminophen may be administered to relieve pain or fever. Typical dosing of acetaminophen for adults is 325 mg to 650 mg and for children (i.e., 6-11 years old) is 10-15 mg/Kg.

[0154] Guaifenesin may be administered to treat symptoms of congestion in the chest and throat. Typical dosing of guaifenesin for adults is 200 mg to 400 mg every 4-6 hours and for children (i.e., 6-11 years old) is 100 mg to 200 mg every 4-6 hours.

[0155] Dextromethorphan hydrobromide may be administered to treat symptoms of a cough.

[0156] Typical dosing of dextromethorphan hydrobromide for adults is 10 mg to 30 mg every 4-8 hours and for children (i.e., 6-11 years old) is 5 mg to 10 mg every 4 hours.

[0157] Loratadine, cetirizine, or diphenhydramine may be administered to treat symptoms of allergic rhinitis and urticaria. Typical dosing of loratadine for adults and children (i.e., 6-11 years old) is 10 mg per day. Typical dosing of cetirizine for adults and children (i.e., 6-11 years old) is 10 mg per day. Typical dosing of diphenhydramine for adults and children (i.e., 6-11 years old) is 12.5 mg or 25 mg per day.

[0158] In embodiments where the active agent is an antacid, the amount of antacid present in each dosage form is from about 10 mg to about 2 g. The amount of antacid present in each dosage form is from about 100 mg to about 1 g. The amount of antacid present in each dosage form is about 500 mg to about 1 mg. The amount of antacid present is about 750 mg or about 800 mg in each dosage form that has a total weight of about 5 g. The antacid may be present in the dosage form in amount from about 1% by weight to about 30% by weight, and about 5% to about 20% by weight.

[0159] In embodiments where the active agent is an anti-foaming agent (also referred to herein as an anti-gas agent), the amount of anti-foaming agent present in each dosage form is from about 1 mg to about 500 mg. The amount of anti-foaming agent present is from about 5 mg to about 250 mg. The amount of anti-foaming agent present is from about 10 mg to about 100 mg. The amount of anti-foaming agent present is about 20 mg or about 80 mg in each dosage form that has a total weight of about 5 g.

[0160] The anti-foaming agent may be present in the dosage form in amount from about 0.01% by weight to about 5% by weight, and 0.1% to about 5% by weight. For an adult dose, the anti-foaming agent is present in an amount from about 0.15% by weight to about 0.25% by weight. For a pediatric dose (e.g., children under 13), the anti-foaming agent is present in an amount from about 0.05% by weight to about 0.15% by weight.

[0161] In some embodiments, the active agent is a histamine H2-receptor antagonist. In these embodiments, the amount of histamine H2-receptor antagonist present in each dosage form is from about 1 mg to about 500 mg, the amount of histamine H2-receptor antagonist is from about 5 mg to about 250 mg. The amount of histamine H2-receptor antagonist present is from about 10 mg to about 100 mg. The amount of histamine H2-receptor antagonist present is about 20 mg or about 80 mg in each dosage form that has a total weight of about 5 g.

[0162] In some embodiments, the active agent is a proton pump inhibitor. In these embodiments, the amount of proton pump inhibitor present in each dosage form is from about 1 mg to about 500 mg. The amount of proton pump inhibitor is from about 5 mg to about 250 mg. The amount of proton pump inhibitor present is from about 10 mg to about 100 mg. The amount of proton pump inhibitor present is about 20 mg or about 80 mg in each dosage form that has a total weight of about 5 g.

[0163] The gummy dosage form of the disclosure includes a gelling agent. Any suitable gelling agent may be used to provide the dosage form with the desired characteristics including, for example, gummy structure, shape and texture. The gelling agent is typically a USP (U.S. Pharmacopeia) grade gelling agent. The gelling agent may be pectin.

[0164] Pectin is a purified carbohydrate obtained by aqueous extraction from citrus peel or apple pomace. Any suitable type of pectin may be use in the dosage form including, for example, high-methoxy pectin and low-methoxy pectin and combinations thereof. Low-methoxy pectin may be amidated, which is often referred to as LMA pectin. Examples of suitable pectins are Genu citrus pectin USP/100 and Genu citrus pectin USP/200 from CP Kelco.

[0165] Pectin may be generally present in the gummy dosage form in an amount of from about 0.01% by weight to about 10% by weight. Pectin is present in an amount of from about 0.5% by weight to about 7% by weight, for example from about 0.5% to about 1%, from about 1% to about 1.5%, from about 1.5% to about 2%, from about 2% to about 2.5%, from about 2.5% to about 3%, from about 3% to about 3.5%, from about 3.5% to about 4%, from about 4% to about 4.5%, from about 4.5% to about 5%, from about 5% to about 5.5%, from about 5.5% to about 6%, from about 6% to about 6.5%, and from about 6.5% to about 7%. Pectin is present in an amount from about 1% by weight to about 5% by weight.

[0166] In some embodiments, the gummy dosage form of the disclosure may further include gelatin. Without being bound by any theory and through extensive testing and research, the applicants discovered that that the presence of gelatin in combination with pectin and the methods of making disclosed herein assists with gelling of the gummy composition and further serves to mask or reduce the taste of the active ingredients.

[0167] Any suitable type of gelatin may be present in the dosage form. For example, the gelatin may be animal-derived gelatin, chemically-modified gelatin, physically-modified gelatin, and combinations thereof. Animal-derived gelatin may be derived from any suitable source such as, for example, pigskin or bovine bone.

[0168] In one embodiment, the gelatin may be hydrolyzed gelatin. Hydrolyzed gelatin is also commonly known as hydrolyzed collagen, collagen hydrolysate, and collagen peptide.

[0169] Hydrolyzed gelatin having a molecular weight ranging from about 2,500 to about 5,000 may be used. An example of a suitable hydrolyzed gelatin is Peptiplus powder from Gelita.

[0170] Gelatin may be generally present in the gummy dosage form in an amount from about 0.01% by weight to about 15% by weight, gelatin is present in an amount of from about 0.5% by weight to about 8% by weight, for example from about 0.5% to about 1%, from about 1% to about 1.5%, from about 1.5% to about 2%, from about 2% to about 2.5%, from about 2.5% to about 3%, from about 3% to about 3.5%, from about 3.5% to about 4%, from about 4% to about 4.5%, from about 4.5% to about 5%, from about 5% to about 5.5%, from about 5.5% to about 6%, from about 6% to about 6.5%, from about 6.5% to about 7%, from about 7% to about 7.5%, and from about 7.5% to about 8%. Gelatin is present in an amount from about 1% by weight to about 5% by weight.

[0171] The gummy dosage form of the disclosure includes saccharides. Generally, saccharide is present in an amount from about 30% by weight to about 99% by weight of the dosage form; sugar is present in an amount from about 40% by weight to about 95% by weight, for example, from about 40% to about 45%, from about 45% to about 50%, from about 50% to about 55%, from about 55% to about 60%, from about 60% to about 65%, from about 65% to about 70%, from about 70% to about 75%, from about 75% to about 80%, from about 80% to about 85%, from about 85% to about 90%, and from about 90% to about 85%.

[0172] In some embodiments, the gummy dosage form includes a polyol. Polyols are also referred to as sugar alcohols. Without being bound by any theory, the presence of a polyol is believed to promote the stability of the gummy dosage form of the disclosure.

[0173] Suitable polyols include, for example, hydrogenated starch hydrolysates, isomalt, lactitol, maltitol, mannitol, sorbitol, erythritol, and xylitol. Combinations of polyols may be used, the polyol is hydrolyzed starch hydrolysates (HSH). HSH typically contains substantial quantities of hydrogenated oligo- and poly-saccharides in addition to monomeric and dimeric polyols. HSH is commonly known to include polyglycitol. An example of a commercially available HSH is Hystar 3375 syrup (75% solids), Hystar 4075 and Hystar 6075 supplied by SPI Polyols. Other commercially available HSH include 75/400 from Roquette and Stabilite liquid HSH and Stabilite powdered HSH supplied by Corn Products Specialty Ingredients.

[0174] One or more polyols may be present in the gummy dosage form in an amount from about 30% by weight to about 99% by weight. In one embodiment, one or more polyols may be present in an amount from about 40% by weight to about 90% by weight, for example, about 40% to about 50%, about 50% to about 60%, about 60% to about 70%, about 70% to about 80%, and about 80% to about 90%. In one embodiment, one or more polyols may be present in an amount from about 40% by weight to about 60% by weight.

[0175] In embodiments in which one or more polyols are present, the ratio of polyol to sugar is typically from about 1:10 to about 10:1 by dry weight, the ratio of polyol to sugar is from about 1:2 to about 2:1 by dry weight, for example, from about 1:1.5 to about 1:5.1.

[0176] In other embodiments, the ratio of polyol to gelling agent is from about 40:1 to about 1:1 by dry weight, the ratio of polyol to gelling agent is from about 30:1 to about 10:1 by dry weight.

[0177] In some embodiments, the gummy dose form includes corn syrup, tapioca syrup, maple syrup, beet syrup, malt, or any other syrup. The syrup may be present without a polyol. In one embodiment, corn syrup may be present in addition to a polyol. Any suitable corn syrup may be used, for example, corn syrup having 36-65 DE (dextrose equivalents), corn syrup 42-43 DE. Corn syrup may contain about 50% by weight to about 90% by weight solids, about 80% solids.

[0178] Syrup may be present in the gummy dosage form in an amount from about 30% by weight to about 99% by weight, corn syrup may be present in an amount from about 40% by weight to about 90% by weight, for example, about 40% to about 50%, about 50% to about 60%, about 60% to about 70%, about 70% to about 80%, and about 80% to about 90%.

[0179] In embodiments in which syrup is present, the ratio of syrup to sugar is typically from about 1:10 to about 10:1 by dry weight. In one embodiment, the ratio of the syrup to sugar is from about 1:2 to about 2:1 by dry weight, for example, from about 1:1.5 to about 1:5.1.

[0180] In other embodiments, the ratio of the syrup to gelling agent is from about 20:1 to about 1:1 by dry weight. In one embodiment, the ratio of the syrup to gelling agent is from about 10:1 to about 2:1 by dry weight.

[0181] The gummy dosage form may optionally include a pH adjusting agent. Any suitable pH adjusting agent may be used that is sufficient to adjust the pH during the manufacture of the dosage form to yield the desired pH. By way of example, the pH adjusting agent may be sodium citrate, citric acid, sodium ascorbate and ascorbic acid. Two or more pH adjusting agents may be used. The pH adjusting agent may be supplied in solid form (e.g., as a powder) or in aqueous solution. For example, citric acid may be supplied in a 50% solution, the pH adjusting agent is sodium citrate or citric acid. In one embodiment, both sodium citrate and citric acid are included in the gummy dosage form as pH adjusting agents.

[0182] The pH adjusting agent may be present in the gummy dosage form in an amount from about 0.1% by weight to about 5% by weight, the pH adjusting agent may be present in an amount from about 1% to about 5% by weight, for example, from about 1% to about 1.5%, from about 1.5% to about 2%, from about 2% to about 2.5%, from about 2.5% to about 3%, from about 3% to about 3.5%, from about 3.5% to about 4.0%, from about 4% to about 4.5%, and from about 4.5% to about 5%.

[0183] In some embodiments, sodium citrate is present in an amount from about 0.1% by weight to about 1% by weight. In one embodiment, sodium citrate is present in an amount from about 0.1% by weight to about 0.5% by weight, for example, from about 0.1% to about 0.2%, from about 0.2% to about 0.3%, from about 0.3% to about 0.4%, and from about 0.4% to about 0.5%.

[0184] In other embodiments, citric acid is present (as 50% aqueous solution) in an amount from about 0.5% by weight to about 3% by weight, for example from about 0.5% to about 1%, from about 1% to about 1.5%, from about 1.5% to about 2%, from about 2% to about 2.5%, and from about 2.5% to about 3%.

[0185] In certain embodiments, the gummy dosage form contains glycerin, also commonly known as glycerol. Without being bound by any theory, glycerin is believed to function as an emollient to stability the dosage form during its preparation, glycerin USP is used. In some embodiments, glycerin is present in the gummy dosage form in addition to the absence of gelatin.

[0186] Glycerin may be present in the gummy dosage form in an amount from about 0.1% by weight to about 10% by weight, glycerin is present in an amount from about 0.5% by weight to about 5% by weight, for example from about 0.5% to about 1%, from about 1% to about 1.5%, from about 1.5% to about 2.0%, from about 2.0% to about 2.5%, from about 2.5% to about 3.0%, from about 3.0% to about 3.5%, from about 3.5% to about 4.0%, from about 4.0% to about 4.5%, and from about 4.5% to about 5.0%.

[0187] In some embodiments, the gummy dosage form contains a flavorant. Any suitable food-grade flavorant may be used to suppress the bitterness of the active ingredients to provide a pleasant taste to the dosage form upon chewing and swallowing. A mixture of two or more flavorants may be used to yield the desired taste characteristic.

[0188] Suitable flavorants include artificial sweeteners such as, for example, sucralose, acesulfame potassium, stevia, sodium saccharine, erythritol, and aspartame. Another suitable flavorant may be a fraction of the lactone group such as, for example, decalactone and dodecalactone (e.g., gamma dodecalactone). Lactone fractions are typically supplied in a propylene glycol solution, in particular from 0.5% to 1% in propylene glycol solution. The flavorant may be orange or cherry flavors. In one embodiment, the flavorant may be menthol.

[0189] In one embodiment, the flavorant is an artificial sweetener. In one embodiment, the artificial sweetener is sucralose.

[0190] The flavorant may be present in an amount up to about 1% by weight, up to about 0.5% by weight, for example, up to about 0.01%, up to about 0.05%, up to about 0.1%, up to about 0.2%, up to about 0.3%, up to about 0.4%, and up to about 0.5%. In certain embodiments, the amount of flavorant present is in a range bounded by any of the foregoing values. Fractions of the lactone group may be present in an amount of from about 1 ppm to 50 ppm, from about 2 ppm to about 10 ppm, and more from about 3 ppm to about 9 ppm.

[0191] A colorant may optionally be added to provide a suitable appearance for the gummy dosage form. Examples of suitable colorants include red or yellow dyes such as FD&C Red #40 and FD&C Yellow #6. Two or more colorants may be combined.

[0192] The gummy dosage form of the disclosure generally has a water content, also referred to as a residual moisture content, of less than about 15% by weight, e.g., about 14% or less, about 13% or less, about 12% or less, about 11% or less, about 10% or less, about 9% or less, about 8% or less, about 7% or less, about 6% or less, or about 5% or less. In other embodiments, the water content of the gummy dosage form is in a range bounded by any of the foregoing values. In one embodiment, the water content of the gummy dosage form is from about 8% by weight to about 15% by weight.

[0193] In some embodiments, the gummy dosage form comprises one or more active agents, a gelling agent, gelatin, sugar, a polyol, and a pH adjusting agent. In other embodiments, the gummy dosage form comprises one or more active agents, a gelling agent, gelatin, sugar, corn syrup, and a pH adjusting agent. In other embodiments, the gummy dosage form comprises one or more active agents, a gelling agent, sugar, a polyol, glycerin, and a pH adjusting agent.

[0194] In some embodiments, the gummy dosage form comprises one or more active agents, pectin, sugar, hydrolyzed starch hydrolysate, hydrolyzed gelatin, and a pH adjusting agent. In other embodiments, the gummy dosage form comprises one or more active agents, pectin, sugar, corn syrup, hydrolyzed gelatin, and a pH adjusting agent.

[0195] In some embodiments, the gummy dosage form comprises one or more active agents, pectin, sugar, hydrolyzed starch hydrolysate, glycerin, and a pH adjusting agent.

[0196] In some embodiments, the gummy dosage form comprises: one or more active agents in an amount from about 0.01% by weight to about 10% by weight; pectin in an amount from about 0.5% by weight to about 7% by weight; sugar in an amount from about 40% by weight to about 95% by weight; optionally hydrolyzed starch hydrolysate in an amount from about 40% by weight to about 90% by weight; optionally hydrolyzed gelatin in an amount from about 0.5% by weight to about 8% by weight; sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and citric acid in an amount from about 0.5% by weight to about 3% by weight, wherein the water content of the gummy dosage form is from about 8% by weight to about 15% by weight.

[0197] In some embodiments, the gummy dosage form comprises: one or more active agents in an amount from about 0.01% by weight to about 10% by weight; pectin in an amount from about 0.5% by weight to about 7% by weight; sugar in an amount from about 40% by weight to about 95% by weight; syrup in an amount from about 40% by weight to about 90% by weight; hydrolyzed gelatin in an amount from about 0.5% by weight to about 8% by weight; sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and citric acid in an amount from about 0.5% by weight to about 3% by weight, wherein the water content of the gummy dosage form is from about 8% by weight to about 15% by weight.

[0198] In some embodiments, the gummy dosage form comprises: one or more active agents in an amount from about 0.01% by weight to about 10% by weight; pectin in an amount from about 0.5% by weight to about 7% by weight; sugar in an amount from about 40% by weight to about 95% by weight; hydrolyzed starch hydrolysate in an amount from about 40% by weight to about 90% by weight; glycerin in an amount from about 0.1% by weight to about 5% by weight; sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and citric acid in an amount from about 0.5% by weight to about 3% by weight, wherein the water content of the gummy dosage form is from about 8% by weight to about 15% by weight.

[0199] In some embodiments, the gummy dosage form comprises: chlorpheniramine maleate; phenylephrine hydrochloride; pectin in an amount from about 0.2% by weight to about 6% by weight; sugar in an amount from about 40% by weight to about 95% by weight; cyclodextrin in an amount from 0% to 10% by weight, sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and citric acid in an amount from about 0.5% by weight to about 3% by weight, wherein the water content of the gummy dosage form is from about 8% by weight to about 15% by weight.

[0200] In some embodiments, the gummy dosage form comprises: diphenhydramine hydochloride; pectin in an amount from about 0.2% by weight to about 6% by weight; sugar in an amount from about 40% by weight to about 95% by weight; cyclodextrin in an amount from 0% to 10% by weight, sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and citric acid in an amount from about 0.5% by weight to about 3% by weight, wherein the water content of the gummy dosage form is from about 8% by weight to about 15% by weight.

[0201] In some embodiments, the gummy dosage form comprises: loratadine; pectin in an amount from about 0.2% by weight to about 6% by weight; sugar in an amount from about 40% by weight to about 95% by weight; cyclodextrin in an amount from 0% to 10% by weight, sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and citric acid in an amount from about 0.5% by weight to about 3% by weight, wherein the water content of the gummy dosage form is from about 8% by weight to about 15% by weight.

[0202] In some embodiments, the gummy dosage form comprises: cetirizine; pectin in an amount from about 0.2% by weight to about 6% by weight; sugar in an amount from about 40% by weight to about 95% by weight; cyclodextrin in an amount from 0% to 10% by weight, sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and citric acid in an amount from about 0.5% by weight to about 3% by weight, wherein the water content of the gummy dosage form is from about 8% by weight to about 15% by weight.

[0203] In some embodiments, the gummy dosage form comprises: aspirin; pectin in an amount from about 0.2% by weight to about 6% by weight; sugar in an amount from about 40% by weight to about 95% by weight; cyclodextrin in an amount from 0% to 10% by weight, sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and citric acid in an amount from about 0.5% by weight to about 3% by weight, wherein the water content of the gummy dosage form is from about 8% by weight to about 15% by weight.

[0204] In some embodiments, the gummy dosage form comprises: pamoate; pectin in an amount from about 0.2% by weight to about 6% by weight; sugar in an amount from about 40% by weight to about 95% by weight; cyclodextrin in an amount from 0% to 10% by weight, sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and citric acid in an amount from about 0.5% by weight to about 3% by weight, wherein the water content of the gummy dosage form is from about 8% by weight to about 15% by weight.

[0205] In some embodiments, the gummy dosage form comprises: naproxen; pectin in an amount from about 0.2% by weight to about 6% by weight; sugar in an amount from about 40% by weight to about 95% by weight; cyclodextrin in an amount from 0% to 10% by weight, sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and citric acid in an amount from about 0.5% by weight to about 3% by weight, wherein the water content of the gummy dosage form is from about 8% by weight to about 15% by weight.

[0206] In some embodiments, the gummy dosage form comprises: acetaminophen; pectin in an amount from about 0.2% by weight to about 6% by weight; sugar in an amount from about 40% by weight to about 95% by weight; cyclodextrin in an amount from 0% to 10% by weight, sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and citric acid in an amount from about 0.5% by weight to about 3% by weight, wherein the water content of the gummy dosage form is from about 8% by weight to about 15% by weight.

[0207] In some embodiments, the gummy dosage form comprises: Sildenafil Citrate, pectin in an amount from about 0.2% by weight to about 6% by weight; sugar in an amount from about 40% by weight to about 95% by weight; cyclodextrin in an amount from 0% to 10% by weight, sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and citric acid in an amount from about 0.5% by weight to about 3% by weight, wherein the water content of the gummy dosage form is from about 8% by weight to about 15% by weight.

[0208] In some embodiments, the gummy dosage form comprises: Tadalafil; pectin in an amount from about 0.2% by weight to about 6% by weight; sugar in an amount from about 40% by weight to about 95% by weight; cyclodextrin in an amount from 0% to 10% by weight, sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and citric acid in an amount from about 0.5% by weight to about 3% by weight, wherein the water content of the gummy dosage form is from about 8% by weight to about 15% by weight.

[0209] In some embodiments, the gummy dosage form comprises: Vardenafil hydrochloride; pectin in an amount from about 0.2% by weight to about 6% by weight; sugar in an amount from about 40% by weight to about 95% by weight; cyclodextrin in an amount from 0% to 10% by weight, sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and citric acid in an amount from about 0.5% by weight to about 3% by weight, wherein the water content of the gummy dosage form is from about 8% by weight to about 15% by weight.

[0210] In some embodiments, the gummy dosage form comprises: metaformin; pectin in an amount from about 0.2% by weight to about 6% by weight; sugar in an amount from about 40% by weight to about 95% by weight; sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and citric acid in an amount from about 0.5% by weight to about 3% by weight, wherein the water content of the gummy dosage form is from about 8% by weight to about 15% by weight.

[0211] In some embodiments, the gummy dosage form comprises: cannabinoids; pectin in an amount from about 0.2% by weight to about 6% by weight; sugar in an amount from about 40% by weight to about 95% by weight; cyclodextrin in an amount from 0% to 10% by weight, sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and citric acid in an amount from about 0.5% by weight to about 3% by weight, wherein the water content of the gummy dosage form is from about 8% by weight to about 15% by weight.

[0212] In some embodiments, the gummy dosage form comprises: an active agent selected from the group consisting of an antacid, an anti-foaming agent, a histamine H2-receptor antagonist, a proton pump inhibitor, or a combination thereof in an amount from about 0.01% by weight to about 10% by weight; pectin in an amount from about 0.5% by weight to about 7% by weight; sugar in an amount from about 40% by weight to about 95% by weight; hydrolyzed starch hydrolysate in an amount from about 40% by weight to about 90% by weight; hydrolyzed gelatin in an amount from about 0.5% by weight to about 8% by weight; sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and citric acid in an amount from about 0.5% by weight to about 3% by weight, wherein the water content of the gummy dosage form is from about 8% by weight to about 15% by weight.

[0213] In some embodiments, the gummy dosage form comprises: an active agent selected from the group consisting of an antacid, an anti-foaming agent, a histamine H2-receptor antagonist, a proton pump inhibitor, or a combination thereof in an amount from about 0.01% by weight to about 10% by weight; pectin in an amount from about 0.5% by weight to about 7% by weight; sugar in an amount from about 40% by weight to about 95% by weight; corn syrup in an amount from about 40% by weight to about 90% by weight; hydrolyzed gelatin in an amount from about 0.5% by weight to about 8% by weight; sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and citric acid in an amount from about 0.5% by weight to about 3% by weight, wherein the water content of the gummy dosage form is from about 8% by weight to about 15% by weight.

[0214] In some embodiments, the gummy dosage form comprises: calcium carbonate, simethicone, famotidine, or omeprazole; pectin in an amount from about 0.5% by weight to about 7% by weight; sugar in an amount from about 40% by weight to about 95% by weight; hydrolyzed starch hydrolysate in an amount from about 40% by weight to about 90% by weight; hydrolyzed gelatin in an amount from about 0.5% by weight to about 8% by weight; sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and citric acid in an amount from about 0.5% by weight to about 3% by weight, wherein the water content of the gummy dosage form is from about 8% by weight to about 15% by weight.

[0215] The gummy dosage form of the disclosure can be prepared by any suitable method including, for example, a batch process or a continuous process. In some embodiments, the components of the dosage form are first combined together in a suitable vessel. The components can be combined in any suitable order.

[0216] In some embodiments, different blends of components are prepared separately and then combined together to form a final blend from which the gummy dosage form is obtained. For example, a primary blend may be combined with a secondary blend to form the final blend. A separate blend containing flavorants and/or colorants and an acid solution may optionally be added in the preparation of the final blend.

[0217] In one embodiment, a primary blend is prepared by combining pectin, sugar, a polyol, and a pH adjusting agent with water. In one embodiment, the primary blend may be prepared by combining pectin, sugar, corn syrup, and a pH adjusting agent with water. A pH adjusting agent such as, for example, sodium citrate may optionally be added to the primary blend. In some embodiments, the primary blend has a pH from about 2 to about 6, from about 2.5 to about 4, and more from about 2.8 to about 3.8.

[0218] In certain aspects, the primary blend is cooked at an appropriate temperature and for an appropriate length of time to provide the primary blend with any suitable moisture content for further processing. In one embodiment, the primary blend has a moisture content after cooking from about 5% by weight to about 25% by weight. In one embodiment, the primary blend has a residual moisture content after cooking from about 9% by weight to about 20% by weight, for example, about 9% to about 10%, about 10% to about 11%, about 11% to about 12%, about 12% to about 13%, about 13% to about 14%, and about 14% to about 15%, about 15% to about 16%, about 16% to about 17%, about 17% to about 18%, about 18% to about 19%, and about 19% to about 20%. Generally, the primary blend may be cooked at a temperature of about 230 F. to about 250 F., for example, about 230 F. to about 235 F., about 235 F. to about 240 F., about 240 F. to about 245 F., and about 245 F. to about 250 F.

[0219] A secondary blend may be added to the primary blend after cooking is completed. The secondary blend may contain one or more components of the gummy dosage form. In some embodiments, the secondary blend includes chlorpheniramine maleate, phenylephrine hydrochloride, and hydrolyzed gelatin. In other embodiments, the secondary blend includes calcium carbonate, simethicone, famotidine, or omeprazole, and hydrolyzed gelatin. Water may be added to the secondary blend to dissolve water-soluble components and/or form a homogenous mixture. Other components may be added to the secondary blend including, for example, glycerin, flavorants and colorants. In one embodiment, an additional blend may be prepared containing glycerin, flavorants and colorants. An acid solution may further be prepared containing citric acid to obtain the desired pH of the final blend. The final blend may be obtained by combining the primary blend, secondary blend, additional blend and citric acid in any order.

[0220] The final blend may be further processed as needed prior to preparation of the gummy dosage form. For example, the final blend may be transferred to a depositor hopper having a jacket to maintain a temperature of from about 180 F. to about 210 F., about 190 to about 200 F. After a suitable amount of time, the final blend may be dispensed from the depositor hopper to product the gummy dosage form of the disclosure.

[0221] The gummy dosage form may be obtained by depositing the final blend into pre-formed plastic molds using conventional techniques. In one embodiment, the plastic molds are blister packs having multiple cavities that provide for unit dose packaging of the gummy dosage form without having to transfer the dosage form from a mold to a separate container. The dosage form solidifies in the plastic molds, which serve as the final packaging. As the temperature of the dosage form cools, the dosage form takes its final shape in the cavities of the blister pack. The blister pack is sealed, for example, using foil. One or more blister packs may be packaged in containers. In one embodiment, the dosage forms may be prepared in molds and transferred to other suitable containers.

[0222] In one embodiment, a pre-determined amount of the final blend, for example based on weight, is dispensed into each cavity to form individual pieces. The individual pieces contain the desired amount of the active ingredients as described herein. For example, individual pieces may contain 4 mg chlorpheniramine maleate and 10 mg phenylephrine hydrochloride for an adult dose and 2 mg chlorpheniramine maleate and 5 mg phenylephrine hydrochloride for a pediatric dose.

[0223] The following examples further illustrate the disclosure but, of course, should not be construed as in any way limiting its scope.

EXAMPLES

Example 1. Pectin Aspirin

[0224] Mix 7.1 g Na Citrate 8.4 g K Citrate, 145.1 g Pectin, and 310.0 g Sucrose until homogeneous to provide a gelling solution. 245 g of water was heated to 200 F. The above mix was added to the hot water with mixing. The solution was brought to the boiling point and boiled for 5 minutes with stirring. 409 g of boiling glucose syrup was slowly added with stirring. Brix of the solution was 73.5. The entire mix was heated until Brix 83.

[0225] In a separate container was mixed 10.8 g of aspirin, 0.65 g Caffeine, and 2.2 g calcium hydroxide. To this was added 20.0 g water and mixed. This mix was then added to the Brix 83 pectin/sugar solution with stirring.

[0226] In a separate container was mixed 7.2 g 50% citric acid solution and 12.0 g pure lime extract. This solution was added to the total mixture with stirring. 0.4 g of green food color was added. Brix was 81.5 The batter was added to silicone trays. The gummy set up within 15 minutes.

Example 2. Diphenhydramine Hydrochloride Containing Pectin Gummy

[0227] Ingredients include: 5.500 grams Sodium Bicarbonate, 3.673 grams Potassium Hydroxide food grade, 1.555 grams Diphenhydramine Hydrochloride, 145.3 grams Citrus Pectin, 500 grams Water, 409.1 grams Glucose Syrup, 310.3 grams Sucrose, 15.0 grams 50% citric acid in water, 4.5 grams Cady Apple Green, and 0.6 grams Green Food Color.

[0228] Combine 500 mL water, potassium hydroxide and sodium bicarbonate, allow the bases to dissolve. Add the pectin. Stir until homogenous and let stand for 15 minutes. Bring to a boil for one minute. The glucose syrup was then added after the minute of boiling. The solution was brought back to a boil. The sucrose was then added and the system heated until Brix 84.

[0229] The solution was cooled to 210 F. and a mixture of citric acid solution, candy apple green flavor and diphenhydramine hydrochloride was added. These were mix into the batter until homogenous. Green food color was then added.

[0230] The solution was then added to silicone molds and allowed to cool to room temperature. Excellent tasting gummies resulted. Each 7. gram gummy had roughly 13 mg diphenhydramine hydrochloride.

Example 3. Multivitamin and Herbal Extract Gummy

[0231] Ingredient list: 21.6 g Collagen, 310.0 g Sucrose, 2.3 g Angelica Sinensis Extract, 145.2 g Candy Pectin by Pacific Pectin, 4.0 g Citric Acid. The ingredients were mixed together until homogeneous. 500 mL was added to a container and heated until 200 F. The above mix was slowly added to the water with stirring and mixed with the water until homogeneous. The mix was brought to the brink of boiling and 0.75 g of coconut oil was added with stirring. The solution was brought to a boil and allowed to boil with stirring for 5 minutes at which time 409.1 g of boiling glucose syrup was added. Brix at this point was 73. Cook until Brix 81 and add 15.2 g vitamin premix and stir until homogenous. The heat was reduced but residual heat raised the brix level to 86-87.

[0232] 15.2 g 50% Citric Acid Solution and 12.1 g Strawberry Extract were combined and added to the gummy batter. 0.75 g of red food color was then added to the gummy batter. The brix level was 85.

[0233] The gummy batter was then added to silicone molds. While the gummies did set up, they could not support their own weight and would flow.

Example 4. Multivitamin and Herbal Extract Gummy

[0234] Ingredient list: 22.0 g Collagen, 310.0 g Sucrose, 2.3 g Angelica Sinensis Extract, 146.3 g Candy Pectin by Pacific Pectin, 4.0 g Citric Acid. The ingredients were mixed together until homogeneous.

[0235] 500 mL was added to a container and heated until 200 OF. The above mix was slowly added to the water with stirring and mixed with the water until homogeneous. The mix was brought to the brink of boiling and 0.75 g of coconut oil was added with stirring. The solution was brought to a boil and allowed to boil with stirring for 5 minutes at which time 409.1 g of boiling glucose syrup was added. Cook until Brix 80 and add 15.3 g vitamin premix (multivitamins with minerals) and stir until homogenous. The heat was reduced but residual heat raised the brix level to 89.

[0236] 15.0 g 50% Citric Acid Solution and 12.0 g Strawberry Extract were combined and added to the gummy batter. 0.75 g of red food color was then added to the gummy batter. The brix level was 87 at the time of addition to molds.

[0237] The gummy batter was then added to silicone molds. While the gummies did set up and were very chewy. They would support their own weight and would hold their shape.

Example 5. Multivitamin and Herbal Extract Gummy

[0238] Ingredient list: 22.3 g Collagen, 310.0 g Sucrose, 2.3 g Angelica Sinensis Extract, 145.2 g Candy Pectin by Pacific Pectin. The ingredients were mixed together until homogeneous. 250 mL was added to a container and heated until 200 OF and reduced to 205 g. The above mix was slowly added to the water with stirring and mixed with the water until homogeneous. The mix was brought to the brink of boiling and 0.75 g of coconut oil was added with stirring. The solution was brought to a boil and allowed to boil with stirring for 5 minutes at which time 407.6 g of boiling glucose syrup was added. Brix at this point was 77. Cook until Brix 80 and add 15.3 g vitamin premix and stir until homogenous. Heat until Brix 85 and add 4.0 g citric acid. 15.1 g 50% Citric Acid Solution and 12.1 g Strawberry Extract were combined and added to the gummy batter. 0.65 g of red food color was then added to the gummy batter. The brix level was 86 at the point of addition to molds.

[0239] The gummy batter was then added to silicone molds. While the gummies did set up and were chewy but not as chewy as when they were at Brix 87. They would support their own weight and would hold their shape.

Example 6. Aspirin Gummy

[0240] Ingredient list: 285.0 grams Water, 40.3 grams pectin; 100.0 grams Sucrose; 3.0 grams Sodium Citrate; 220.0 grams Sucrose; 6.0 grams Coconut Oil; 468.0 grams Boling Corn Syrup; 4.0 grams Pure Lime Extract; 11.0 grams Calcium Acetylsalicylate; 22.0 grams Maltodextrin; 20.0 grams 50% Citric Acid solution (in 50% glycerol/water); 5.0 grams glycerol; 1.4 grams Green color

[0241] Method: In a separate container is added the pectin, 100 grams of sucrose, and the sodium citrate. The components are mixed until homogeneous. This is mix 1. In a separate container calcium acetyl salicylate and maltodextrin are combined and shifted together until homogeneous. This is Mix 2. In a separate container is added the citric acid solution, green color, and lime flavor. All is mixed and warmed to 175 F. until all is dissolved. This is Mix 3.

[0242] Water is heated to 200 F. in a saucepan. To the hot water is added Mix 1 with stirring. The mixture is stirred until the pectin fully swells and disperses which takes roughly 3-5 minutes. The solution is brought to a boil. To the boiling Mix 1 solution is added the remaining sucrose with stirring. The sucrose is allowed to dissolve.

[0243] Coconut oil is then added dropwise to the boiling mixture with stirring.

[0244] The boiling corn syrup is then added to the boiling pectin/sugars/oil mix. And the system heated until Brix 75. Mix 2 was then slowly sprinkled into the Brix 75 solution to avoid clumping. The mixture was heated to Brix 82 at which time Mix 3 was added dropwise with stirring until completely homogenous.

The gummy batter was then added to silicone molds.

Example 7. Aspirin, N-Acetylglucosamine Gummy

[0245] Ingredient List: 375.0 grams Water; 5.0 grams Glycerol; 10.8 grams Acetylsalicylic Acid; 0.7 grams Caffeine; 2.2 grams Calcium Hydroxide; 40.0 grams pectin; 50.0 grams N-acetyl glucosamine; 50.0 grams Fructose; 3.0 grams Sodium Citrate; 20.0 grams g-cyclodextrin; 80.0 grams Fructose; 120.0 grams Sucrose; 410.0 grams Boling Glucose Syrup; 2.0 grams Lime Flavor Water Soluble; 2.0 grams Lime Flavor Oil Soluble; 25.0 grams 50% Citric Acid solution (in 50% glycerol/water); 1.2 grams Green color

[0246] Method: In a separate container is added the pectin, 50 grams of fructose, 50 grams N-acetyl glucosamine and the sodium citrate. The components are mixed until homogeneous. This is mix 1. In a separate container is added cyclodextrin, fructose, and sucrose and these are fully mixed. This is mix 2. In a separate container is added the citric acid solution, green color, and lime flavor. All is mixed and warmed to 175 F. until all is dissolved. This is Mix 3.

[0247] Water is heated to 200 F. in a saucepan. To the hot water is added calcium hydroxide and caffeine and both are allowed to fully dissolve. To the hot water is then added the aspirin and the aspirin is allowed to fully dissolve. Glycerol is then added.

To the hot water is added Mix 1 with stirring. The mixture is stirred until the pectin fully swells and disperses which takes roughly 3-5 minutes. The solution is brought to a boil.
To the boiling Mix 1 solution is added Mix 2 with stirring. The Mix 2 is allowed to dissolve. The boiling corn syrup is then added to the boiling pectin/sugars/oil mix. And the system heated to Brix 80 at which time the system was cooled to 220-230 F. and Mix 3 was added dropwise with stirring until completely homogenous.
The gummy batter was then added to silicone molds.

Example 8. CBD Gummy

[0248] Ingredient List: 400 grams Water; 37.5 grams Pectin; 220.0 grams Sucrose; 50.0 grams Fructose; 3.0 grams Sodium Citrate; 5.0 grams Glycerol; 20.0 grams Mannitol; 20.0 grams g-Cyclodextrin; 7.5 grams Coconut Oil; 410.0 grams Glucose Syrup; 2.2 grams RSO CBD Serum 20:1 (63.0% CBD); 75 grams 50% Citric Acid solution (50-50 water glycerol); 5.1 grams Cochineal Pink; 4.0 grams Watermelon Flavor

[0249] Method: To a container was added the water which is then heated to 200 F. Glycerol was then added to the water. To a separate container was added the pectin, 100 grams of sucrose and the sodium citrate and mixed until homogeneous. This mixture was then added to the hot water with rapid mixing. The water becomes more viscous as the pectin dissolved. The water was brought to a gentle boil and the mixing continued for 3-5 minutes.

[0250] To a separate container are added the remainder of the sucrose, fructose, mannitol and cyclodextrin. These components are mixed until homogenous. The sugar mixture was then added to swelled pectin solution above with rapid mixing and maintain the boil.

[0251] To a separate container was added the glucose syrup. The glucose syrup was brought to a boil and reduced to a Brix 85. The boiling glucose syrup was then slowly added to the pectin solution slowly with rapid mixing. Coconut oil and RSO CBD Serum 20:1 were added with mixing. Brix was at 70. The mixture was brought to a strong boil.

[0252] The system was then heated to Brix 79. The system was cooled to 210-220 F. at which time the color was added followed by the flavors and then the citric acid solution.

The completed gummy batter was then poured into molds.

Example 9. Cetirizine Gummy

[0253] Ingredient List: 285.0 grams Water; 40.3 grams pectin; 101.0 grams Sucrose; 3.0 grams Sodium Citrate; 235.0 grams Sucrose; 14.0 grams Clusterdextrin; 20.0 grams Mannitol; 6.0 grams Coconut Oil; 410.0 grams Boling Glucose Syrup; 6.5 grams Blood Orange Extract; 1.30 grams Cetirizine Dihydrochloride; 20.0 grams 50% Citric Acid solution (in 50% glycerol/water); 5.0 grams glycerol; 0.6 grams orange color

[0254] Method: In a separate container is added the pectin, 100 grams of sucrose, and the sodium citrate. The components are mixed until homogeneous. This is mix 1. In a separate container is added the remaining sucrose, cluster dextrin, and mannitol. The components are mixed until homogeneous. This is mix 2.

[0255] In a separate container is added the citric acid solution, orange color, blood orange flavor and the cetirizine. All is mixed and warmed to 175 F. until all is dissolved. This is Mix 3.

[0256] Water is heated to 200 F. in a saucepan. To the hot water is added Mix 1. The mixture is stirred until the pectin fully swells and disperses which takes roughly 3-5 minutes. The solution is brought to a boil. To the boiling Mix 1 solution is added Mix 2 with stirring.

[0257] Coconut oil is then added dropwise to the boiling mixture with stirring. The boiling glucose syrup is then added to the boiling pectin/sugars/oil mix. The mixture was heated to Brix 80 at which time Mix 3 was added dropwise with stirring. The gummy batter was then added to silicone molds.

Example 10. Cetirizine Gummy that is Safer for Diabetics and Lowered Instance of Tooth Decay

[0258] Ingredient List: 285.0 grams Water; 40.3 grams pectin; 100.0 grams Trehalose; 3.0 grams Sodium Citrate; 167.5 grams Palatinose; 67.5 grams Trehalose; 15.0 grams b-cylcodextrin; 20.0 grams Mannitol; 6.0 grams Coconut Oil; 410.0 grams Boling Psicose Syrup; 6.5 grams Blood Orange Extract; 1.30 grams Cetirizine Dihydrochloride; 20.0 grams 50% Citric Acid solution (in 50% glycerol/water); 5.0 grams glycerol; 0.6 grams orange color

[0259] Method: In a separate container is added the pectin, 100 grams of trehalose, and the sodium citrate. The components are mixed until homogeneous. This is mix 1.

In a separate container is added the remaining trehalose, palatinose, cyclodextrin, and mannitol. The components are mixed until homogeneous. This is mix 2. In a separate container is added the citric acid solution, orange color, blood orange flavor and the cetirizine. All is mixed and warmed to 175 F. until all is dissolved. This is Mix 3.

[0260] Water is heated to 200 F. in a saucepan. To the hot water is added Mix 1. The mixture is stirred until the pectin fully swells and disperses which takes roughly 3-5 minutes. The solution is brought to a boil.

[0261] Mix 2 is added to the boiling psicose syrup which is then added to the boiling pectin/sugars/oil mix. Coconut oil is then added dropwise to the boiling mixture with stirring. The mixture was heated to Brix 79 at which time Mix 3 was added dropwise with stirring. The gummy batter was then added to silicone molds.

Example 11. Low Glycemic Index Cetirizine Gummy

[0262] Ingredient List: 285.0 grams Water; 40.3 grams pectin; 100.0 grams Trehalose; 3.0 grams Sodium Citrate; 167.5 grams Palatinose; 67.5 grams Trehalose; 15.0 grams b-cylcodextrin; 20.0 grams Mannitol; 410.0 grams Boling Psicose Syrup; 6.5 grams Orange Flavor USP; 1.32 grams Cetirizine Dihydrochloride; 20.0 grams 50% Citric Acid solution (in 50% glycerol/water); 5.0 grams glycerol; 0.6 grams orange color

[0263] Method: In a separate container is added the pectin, 100 grams of trehalose, cetirizine dihydrochloride, cyclodextrin and the sodium citrate. The components are mixed until homogeneous. This is mix 1. In a separate container is added the remaining trehalose, palatinose, and mannitol. The components are mixed until homogeneous. This is mix 2. In a separate container is added the citric acid solution, orange color, and orange flavor. All is mixed and warmed to 175 F. until all is dissolved. This is Mix 3.

[0264] Water is heated to 200 F. in a saucepan. To the hot water is added Mix 1. The mixture is stirred until the pectin fully swells and disperses which takes roughly 3-5 minutes. The solution is brought to a boil.

Mix 2 is added to the boiling psicose syrup which is then added to the boiling pectin/sugars/oil mix. The mixture was heated to Brix 79 at which time Mix 3 was added dropwise with stirring.
The gummy batter was then added to silicone molds.

Example 12. Cetirizine Gummy

[0265] Ingredient List: 285.0 grams Water; 40.3 grams pectin; 100.0 grams Sucrose; 3.0 grams Sodium Citrate; 130 Grams Sucrose; 100 grams Fructose; 15.0 grams b-cyclodextrin; 20.0 grams Mannitol; 410.0 grams Boling Glucose Syrup; 6.5 grams Orange Flavor USP; 1.32 grams Cetirizine Dihydrochloride; 20.0 grams 50% Citric Acid solution (in 50% glycerol/water); 5.0 grams glycerol; 0.6 grams orange color

[0266] Method: In a separate container is added the pectin, 100 grams of sucrose, cetirizine dihydrochloride, cyclodextrin and the sodium citrate. The components are mixed until homogeneous. This is mix 1. In a separate container is added the remaining sucrose, fructose, and mannitol. The components are mixed until homogeneous. This is mix 2. In a separate container is added the citric acid solution, orange color, and orange flavor. All is mixed and warmed to 175 F. until all is dissolved. This is Mix 3.

[0267] Water is heated to 200 F. in a saucepan. To the hot water is added Mix 1. The mixture is stirred until the pectin fully swells and disperses which takes roughly 3-5 minutes. The solution is brought to a boil. Mix 2 is added to the boiling glucose syrup is then added to the boiling pectin/sugars/oil mix. The mixture was heated to Brix 82 at which time Mix 3 was added dropwise with stirring. The gummy batter was then added to silicone molds.

Example 13. Loratadine Gummy

[0268] Ingredient List: 285.0 grams Water; 40.3 grams pectin; 100.0 grams Sucrose; 3.0 grams Sodium Citrate; 130 Grams Sucrose; 100 grams Fructose; 15.0 grams b-cyclodextrin; 20.0 grams Mannitol; 410.0 grams Boling Glucose Syrup; 6.5 grams Orange Flavor USP; 1.42 grams Loratadine Hydrochloride; 20.0 grams 50% Citric Acid solution (in 50% glycerol/water); 5.0 grams glycerol; 0.6 grams orange color

[0269] Method: In a separate container is added the pectin, 100 grams of sucrose, loratadine hydrochloride, cyclodextrin and the sodium citrate. The components are mixed until homogeneous. This is mix 1. In a separate container is added the remaining sucrose, fructose, and mannitol. The components are mixed until homogeneous. This is mix 2. In a separate container is added the citric acid solution, orange color, and orange flavor. All is mixed and warmed to 175 F. until all is dissolved. This is Mix 3.

[0270] Water is heated to 200 F. in a saucepan. To the hot water is added Mix 1. The mixture is stirred until the pectin fully swells and disperses which takes roughly 3-5 minutes. The solution is brought to a boil. Mix 2 is added to the boiling glucose syrup is then added to the boiling pectin/sugars/oil mix. The mixture was heated to Brix 79 at which time Mix 3 was added dropwise with stirring. The gummy batter was then added to silicone molds.

Example 14. Tadalafil Gummy

[0271] Ingredient List: 285.0 grams Water; 40.3 grams pectin; 100.0 grams Sucrose; 3.0 grams Sodium Citrate; 130 Grams Sucrose; 100 grams Fructose; 15.0 grams b-cyclodextrin; 20.0 grams Mannitol; 410.0 grams Boling Glucose Syrup; 6.5 grams Orange Flavor USP; 1.36 grams Tadalafil Hydrochloride; 20.0 grams 50% Citric Acid solution (in 50% glycerol/water); 5.0 grams glycerol; 4.5 grams Root Beer flavor; 0.6 grams brown caramel color

[0272] Method: In a separate container is added the pectin, 100 grams of sucrose, tadalafil hydrochloride, cyclodextrin and the sodium citrate. The components are mixed until homogeneous. This is mix 1.

[0273] In a separate container is added the remaining sucrose, fructose, and mannitol. The components are mixed until homogeneous. This is mix 2. In a separate container is added the citric acid solution, brown color, and root beer flavor. All is mixed and warmed to 175 F. until all is dissolved. This is Mix 3.

[0274] Water is heated to 200 F. in a saucepan. To the hot water is added Mix 1. The mixture is stirred until the pectin fully swells and disperses which takes roughly 3-5 minutes. The solution is brought to a boil. Mix 2 is added to the boiling glucose syrup is then added to the boiling pectin/sugars/oil mix. The mixture was heated to Brix 79 at which time Mix 3 was added dropwise with stirring. The gummy batter was then added to silicone molds.

Example 14. Tadalafil Gummy

[0275] Ingredient List: 285.0 grams Water; 40.3 grams pectin; 100.0 grams Sucrose; 3.0 grams Sodium Citrate; 130 Grams Sucrose; 100 grams Fructose; 15.0 grams b-cyclodextrin; 20.0 grams Mannitol; 410.0 grams Boling Glucose Syrup; 2.80 grams Tadalafil Hydrochloride; 20.0 grams 50% Citric Acid solution (in 50% glycerol/water); 5.0 grams glycerol; 4.5 grams Bourbon Flavor; 0.6 grams brown caramel color

[0276] Method: In a separate container is added the pectin, 100 grams of sucrose, cyclodextrin and the sodium citrate. The components are mixed until homogeneous. This is mix 1.

[0277] In a separate container is added the remaining sucrose, cyclodextrin, fructose, and mannitol. The components are mixed until homogeneous. This is mix 2. In a separate container is added the citric acid solution, cyclodextrin, tadalafil hydrochloride, brown color, and bourbon flavor. All is mixed and warmed to 175 F. until all is dissolved. This is Mix 3.

[0278] Water is heated to 200 F. in a saucepan. To the hot water is added Mix 1. The mixture is stirred until the pectin fully swells and disperses which takes roughly 3-5 minutes. The solution is brought to a boil. Mix 2 is added to the boiling glucose syrup is then added to the boiling pectin/sugars/oil mix. The mixture was heated to Brix 79 at which time Mix 3 was added dropwise with stirring. The gummy batter was then added to silicone molds.

Example 15. Vardenafil Gummy

[0279] Ingredient List: 285.0 grams Water; 40.3 grams pectin; 100.0 grams Sucrose; 3.0 grams Sodium Citrate; 130 Grams Sucrose; 100 grams Fructose; 15.0 grams b-cyclodextrin; 20.0 grams Mannitol; 410.0 grams Boling Glucose Syrup; 1.51 grams vardenafil hydrochloride; 20.0 grams 50% Citric Acid solution (in 50% glycerol/water); 5.0 grams glycerol; 4.5 grams Root Beer flavor; 0.6 grams brown caramel color

[0280] Method: In a separate container is added the pectin, 100 grams of sucrose, vardenafil hydrochloride, cyclodextrin and the sodium citrate. The components are mixed until homogeneous. This is mix 1.

In a separate container is added the remaining sucrose, fructose, and mannitol. The components are mixed until homogeneous. This is mix 2. In a separate container is added the citric acid solution, brown color, and root beer flavor. All is mixed and warmed to 175 F. until all is dissolved. This is Mix 3.

[0281] Water is heated to 200 F. in a saucepan. To the hot water is added Mix 1. The mixture is stirred until the pectin fully swells and disperses which takes roughly 3-5 minutes. The solution is brought to a boil. Mix 2 is added to the boiling glucose syrup is then added to the boiling pectin/sugars/oil mix. The mixture was heated to Brix 79 at which time Mix 3 was added dropwise with stirring. The gummy batter was then added to silicone molds.

Example 16. Sildenafil Gummy

[0282] Ingredient List: 285.0 grams Water; 40.3 grams pectin; 100.0 grams Sucrose; 3.0 grams Sodium Citrate; 130 Grams Sucrose; 100 grams Fructose; 15.0 grams b-cyclodextrin; 20.0 grams Mannitol; 410.0 grams Boling Glucose Syrup; 7.65 grams sildenafil citrate; 20.0 grams 50% Citric Acid solution (in 50% glycerol/water); 5.0 grams glycerol; 4.5 grams Raspberry flavor; 0.6 grams Red color

[0283] Method: In a separate container is added the pectin, 100 grams of sucrose, sildenafil citrate, cyclodextrin and the sodium citrate. The components are mixed until homogeneous. This is mix 1. In a separate container is added the remaining sucrose, fructose, and mannitol. The components are mixed until homogeneous. This is mix 2. In a separate container is added the citric acid solution, red color, and raspberry flavor. All is mixed and warmed to 175 F. until all is dissolved. This is Mix 3.

[0284] Water is heated to 200 F. in a saucepan. To the hot water is added Mix 1. The mixture is stirred until the pectin fully swells and disperses which takes roughly 3-5 minutes. The solution is brought to a boil. Mix 2 is added to the boiling glucose syrup is then added to the boiling pectin/sugars/oil mix. The mixture was heated to Brix 79 at which time Mix 3 was added dropwise with stirring. The gummy batter was then added to silicone molds.

Example 17. Sildenafil Chocolate Gummy

[0285] Ingredient List: 285.0 grams Water; 40.3 grams pectin; 100.0 grams Sucrose; 3.0 grams Sodium Citrate; 130 Grams Sucrose; 100 grams Fructose; 30 grams Cacao Powder, 15.0 grams g-cyclodextrin; 20.0 grams Mannitol; 410.0 grams Boling Glucose Syrup; 8.10 grams sildenafil citrate; 20.0 grams 50% Citric Acid solution (in 50% glycerol/water); 5.0 grams glycerol; 1.2 grams Raspberry flavor

[0286] Method: In a separate container is added the pectin, 100 grams of sucrose, sildenafil citrate, cyclodextrin and the sodium citrate. The components are mixed until homogeneous. This is mix 1. In a separate container is added the remaining sucrose, cacao powder, fructose, and mannitol. The components are mixed until homogeneous. This is mix 2. In a separate container is added the citric acid solution, and raspberry flavor. All is mixed and warmed to 175 F. until all is dissolved. This is Mix 3. Water is heated to 200 F. in a saucepan. To the hot water is added Mix 1. The mixture is stirred until the pectin fully swells and disperses which takes roughly 3-5 minutes. The solution is brought to a boil. Mix 2 is added to the boiling glucose syrup is then added to the boiling pectin/sugars/oil mix. The mixture was heated to Brix 79 at which time Mix 3 was added dropwise with stirring. The gummy batter was then added to silicone molds.

Example 18. Naproxen Gummy

[0287] Ingredient List: 285.0 grams Water; 40.3 grams pectin; 100.0 grams Sucrose; 6.0 grams Naproxen Sodium; 130 Grams Sucrose; 100 grams Fructose; 18.0 grams b-cyclodextrin; 20.0 grams Mannitol; 410.0 grams Boling Glucose Syrup; 4.5 grams Lemon Flavor USP; 20.0 grams 50% Citric Acid solution (in 50% glycerol/water); 5.0 grams glycerol; 0.8 grams Yellow Color

[0288] Method: In a separate container is added the pectin, 100 grams of sucrose, naproxen sodium, and cyclodextrin. The components are mixed until homogeneous. This is mix 1. In a separate container is added the remaining sucrose, fructose, and mannitol. The components are mixed until homogeneous. This is mix 2. In a separate container is added the citric acid solution, yellow color, and lemon flavor. All is mixed and warmed to 175 F. until all is dissolved. This is Mix 3.

[0289] Water is heated to 200 F. in a saucepan. To the hot water is added Mix 1. The mixture is stirred until the pectin fully swells and disperses which takes roughly 3-5 minutes. The solution is brought to a boil. Mix 2 is added to the boiling glucose syrup is then added to the boiling pectin/sugars/oil mix. The mixture was heated to Brix 78 at which time Mix 3 was added dropwise with stirring. The gummy batter was then added to silicone molds.

Example 19. Ibuprofen Gummy

[0290] Ingredient List: 285.0 grams Water; 40.3 grams pectin; 100.0 grams Sucrose; 9.0 grams Ibuprofen Lysate; 130 Grams Sucrose; 100 grams Fructose; 20.0 grams b-cyclodextrin; 20.0 grams Mannitol; 410.0 grams Boling Glucose Syrup; 4.5 grams Lime Flavor USP; 20.0 grams 50% Citric Acid solution (in 50% glycerol/water); 5.0 grams glycerol; 0.6 grams Green color

[0291] Method: In a separate container is added the pectin, 100 grams of sucrose, ibuprofen lysate, and cyclodextrin. The components are mixed until homogeneous. This is mix 1. In a separate container is added the remaining sucrose, fructose, and mannitol. The components are mixed until homogeneous. This is mix 2. In a separate container is added the citric acid solution, green color, and lime flavor. All is mixed and warmed to 175 F. until all is dissolved. This is Mix 3.

[0292] Water is heated to 200 F. in a saucepan. To the hot water is added Mix 1. The mixture is stirred until the pectin fully swells and disperses which takes roughly 3-5 minutes. The solution is brought to a boil. Mix 2 is added to the boiling glucose syrup is then added to the boiling pectin/sugars/oil mix. The mixture was heated to Brix 78 at which time Mix 3 was added dropwise with stirring. The gummy batter was then added to silicone molds.

Example 20. Acetaminophen Gummy

[0293] Ingredient List: 285.0 grams Water; 40.3 grams pectin; 100.0 grams Sucrose; 10.1 grams acetaminophen; 130 Grams Sucrose; 100 grams Fructose; 25.0 grams b- and g-cyclodextrin (1:1); 3.0 grams Sodium Citrate, 20.0 grams Mannitol; 410.0 grams Boling Glucose Syrup; 4.5 grams Watermelon Flavor; 20.0 grams 50% Citric Acid solution (in 50% glycerol/water); 5.0 grams glycerol; 0.7 grams Red color

[0294] Method: In a separate container is added the pectin, 100 grams of sucrose, acetaminophen, cyclodextrin and the sodium citrate. The components are mixed until homogeneous. This is mix 1. In a separate container is added the remaining sucrose, fructose, and mannitol. The components are mixed until homogeneous. This is mix 2. In a separate container is added the citric acid solution, red color, and watermelon flavor. All is mixed and warmed to 175 F. until all is dissolved. This is Mix 3.

[0295] Water is heated to 200 F. in a saucepan. To the hot water is added Mix 1. The mixture is stirred until the pectin fully swells and disperses which takes roughly 3-5 minutes. The solution is brought to a boil. Mix 2 is added to the boiling glucose syrup is then added to the boiling pectin/sugars/oil mix. The mixture was heated to Brix 78 at which time Mix 3 was added dropwise with stirring. The gummy batter was then added to silicone molds.

Example 21. Acetaminophen Gummy

[0296] Ingredient List: 285.0 grams Water; 40.3 grams pectin; 100.0 grams Sucrose; 10.1 grams acetaminophen; 130 Grams Sucrose; 100 grams Fructose; 25.0 grams b- and g-cyclodextrin (1:1); 3.0 grams sodium citrate, 20.0 grams Mannitol; 410.0 grams Boling Glucose Syrup; 4.5 grams Watermelon Flavor; 20.0 grams 50% Citric Acid solution (in 50% glycerol/water); 5.0 grams glycerol; 0.7 grams Red color

[0297] Method: In a separate container is added the pectin, 100 grams of sucrose, cyclodextrin and the sodium citrate. The components are mixed until homogeneous. This is mix 1. In a separate container is added the remaining sucrose, cyclodextrin, fructose, and mannitol. The components are mixed until homogeneous. This is mix 2. In a separate container is added the citric acid solution, cyclodextrin, acetaminophen, red color, and watermelon flavor. All is mixed and warmed to 175 F. until all is dissolved. This is Mix 3.

[0298] Water is heated to 200 F. in a saucepan. To the hot water is added Mix 1. The mixture is stirred until the pectin fully swells and disperses which takes roughly 3-5 minutes. The solution is brought to a boil. Mix 2 is added to the boiling glucose syrup is then added to the boiling pectin/sugars/oil mix. The mixture was heated to Brix 78 at which time Mix 3 was added dropwise with stirring. The gummy batter was then added to silicone molds.

Example 22. Metaformin Gummy

[0299] Ingredient List: 285.0 grams Water; 40.3 grams pectin; 100.0 grams Sucrose; 10.1 grams metaformin; 130 Grams Sucrose; 100 grams Fructose; 20.0 grams Mannitol; 410.0 grams Boling Glucose Syrup; 4.5 grams Peach Flavor; 25.0 grams 50% Citric Acid solution (in 50% glycerol/water); 5.0 grams glycerol; 0.3 grams Orange color

[0300] Method: In a separate container is added the pectin, 100 grams of sucrose, metaformin. The components are mixed until homogeneous. This is mix 1. In a separate container is added the remaining sucrose, fructose, and mannitol. The components are mixed until homogeneous. This is mix 2. In a separate container is added the citric acid solution, orange color, and peach flavor. All is mixed and warmed to 175 F. until all is dissolved. This is Mix 3.

[0301] Water is heated to 200 F. in a saucepan. To the hot water is added Mix 1. The mixture is stirred until the pectin fully swells and disperses which takes roughly 3-5 minutes. The solution is brought to a boil. Mix 2 is added to the boiling glucose syrup is then added to the boiling pectin/sugars/oil mix. The mixture was heated to Brix 78 at which time Mix 3 was added dropwise with stirring. The gummy batter was then added to silicone molds.

Example 18. Chlorpheniramine Maleate Gummy

[0302] Ingredient List: 285.0 grams Water; 40.3 grams pectin; 100.0 grams Sucrose; 2.0 grams chlorpheniramine maleate; 130 Grams Sucrose; 100 grams Fructose; 15.0 grams b-cyclodextrin; 20.0 grams Mannitol; 410.0 grams Boling Glucose Syrup; 4.5 grams Lemon Flavor USP; 20.0 grams 50% Citric Acid solution (in 50% glycerol/water); 5.0 grams glycerol; 0.8 grams Yellow Color

[0303] Method: In a separate container is added the pectin, 100 grams of sucrose, chlorpheniramine maleate, and cyclodextrin. The components are mixed until homogeneous. This is mix 1. In a separate container is added the remaining sucrose, fructose, and mannitol. The components are mixed until homogeneous. This is mix 2. In a separate container is added the citric acid solution, yellow color, and lemon flavor. All is mixed and warmed to 175 F. until all is dissolved. This is Mix 3.

[0304] Water is heated to 200 F. in a saucepan. To the hot water is added Mix 1. The mixture is stirred until the pectin fully swells and disperses which takes roughly 3-5 minutes. The solution is brought to a boil. Mix 2 is added to the boiling glucose syrup is then added to the boiling pectin/sugars/oil mix. The mixture was heated to Brix 78 at which time Mix 3 was added dropwise with stirring. The gummy batter was then added to silicone molds.

[0305] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

[0306] The use of the terms a and an and the and at least one and similar referents in the context of describing the disclosure (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The use of the term at least one followed by a list of one or more items (for example, at least one of A and B) is to be construed to mean one item selected from the listed items (A or B) or any combination of two or more of the listed items (A and B), unless otherwise indicated herein or clearly contradicted y context. The terms comprising, having, including, and containing are to be construed as open-ended terms (i.e., meaning including, but not limited to,) unless otherwise noted. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., such as) provided herein, is intended merely to better illuminate the disclosure and does not pose a limitation on the scope of the disclosure unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the disclosure.

[0307] Embodiments of this disclosure are described herein, including the best mode known to the inventors for carrying out the disclosure. Variations of those embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors expect skilled artisans to employ such variations as appropriate, and the inventors intend for the disclosure to be practiced otherwise than as specifically described herein. Accordingly, this disclosure includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the disclosure unless otherwise indicated herein or otherwise clearly contradicted by context.