Direct compressible gummies

Abstract

Provided arc gummy-like products formed by hydrating dry tableting compositions, the dry tablets formed using tableting compression methods on the dry tableting compositions. The tablets may be hydrated using a salt water bath or a coating pan technique, for example. The dry tableting compositions and the hydrated tablets may comprise one or more active pharmaceutical ingredients, therapeutic agents, or supplements; one or more sweeteners; gelatin; cellulose; one or one or more acids; and one or more flavors.

Description

DIRECT COMPRESSIBLE GUMMIESFIELD

[0001] The present disclosure generally relates to gummies, and more specifically, to gummies prepared using direct compression techniques.BACKGROUND

[0002] Traditionally, gummies are chewable products typically provided in a sweet or candy form. They are a gelatin-based product that are produced using a molding technique. Specifically, to produce gummies, a multi-step process is typically used that includes weighing the ingredients, mixing the ingredients, dissolving the ingredients in water, heating the ingredients, forming a molded product by placing the liquid or gel-like mixture in a mold, and cooling the molded product.

[0003] The gelatin is typically mixed together with sweeteners, starch, and water. The specific combination of gelatin and water usually forms a thick, gel-like solution. This gel-like solution is then molded into any of various shapes or sizes. Because gelatin is a tasteless, odorless, and colorless material, sweeteners, colorants and / or flavors can be used to develop a product that is palatable and visually appealing to consumers.

[0004] Although gummies are traditionally provided as a candy or sweet product, they are also often used as dosage forms for therapeutic agents or supplements, such as cannabidiol, vitamins, etc.SUMMARY

[0005] Described herein are solid dosage forms (i.e., gummy-like products) prepared using direct compression techniques on dry tableting compositions, and methods of making such solid dosage forms. The solid dosage forms resemble gummies that melt in the oral cavity with mild chewing. Specifically, the solid dosage forms are prepared by first forming a compressed dry tablet from a dry tableting composition, and then hydrating the compressed dry tablet to form the gummy-like dosage form. No extreme heat or cooking is required in the manufacturing process. For example, processes other than those described herein may require cooking at temperatures ranging from about 75°C- 100°C, whereas the processes described herein do not require such high temperatures. Themanufacturing methods described herein can use existing tableting equipment. By using existing tableting equipment (and without the need for gummy-specific production equipment), the manufacturing methods described can be more efficient, more simple, and less expensive than conventional gummy manufacturing methods. Conventional gummy-production techniques also pose dose weight accuracy challenges for products comprising a therapeutic agent, active pharmaceutical ingredient, and / or supplement. For example, the use of extreme heat as described above may cause thermosensitive ingredients to be degraded during conventional manufacturing. Additional amounts of such ingredients are commonly added to compensate for loss during manufacture and storage, which can cause dosage inaccuracies that can be avoided using the manufacturing processes described herein.

[0006] Specifically, the processes for manufacturing the solid dosage forms described herein include forming a novel compressed dry tablet using tableting equipment and techniques. This includes compressing a dry tableting composition to form the compressed dry tablet. Once the compressed dry tablet is formed, it is hydrated using one of several hydration techniques to provide a gummy- like product that can melt or disintegrate in the oral cavity when in contact with saliva and / or with mild chewing.

[0007] The solid dosage forms described herein can comprise cellulose, sweetener(s) and gelatin. These three ingredients form the gummy structure. Ingredients such as therapeutic agents, nutritional or vitamin supplements, and / or active pharmaceutical ingredients may also be included. Ingredients such as citric acid, dyes, bulking agents such as corn syrup solids and food starch, and binders like povidone may also be included. Flavors may be added to make the product more palatable for a consumer.

[0008] In some embodiments, a dry tableting composition is provided. The dry tableting composition may include 30-60 wt. % one or more sweeteners; 5-40 wt. % gelatin; 10-20 wt. % cellulose; and 0.01-30 wt. % one or more active pharmaceutical ingredients (APIs), therapeutic agents, or supplements.

[0009] In some embodiments, the one or more APIs, therapeutic agents, or supplements in the dry tableting composition comprise loratadine, desloratadine, azelastine hydrochloride, pseudoephedrinehydrochloride, phenylephrine bitartrate, doxylamine succinate, acetaminophen, naproxen sodium, ibuprofen, diphenhydramine hydrochloride, guaifenesin, chlorpheniramine maleate, calcium carbonate, calcium citrate, ascorbic acid, vitamins, minerals, pharmaceutically acceptable salts thereof, or combinations thereof.

[0010] In some embodiments, the one or more sweeteners in the dry tableting composition comprise one or more of compressible sugar, sucrose, fructose, com syrup, sorbitol, maltitol, xylitol, isomaltitol, mannitol, or erythritol.

[0011] In some embodiments, the dry tableting composition comprises 0.1-3 wt. % one or more of citric acid anhydrous, citric acid, tartaric acid, tartaric acid anhydrous, ascorbic acid, or ascorbic acid anhydrous.

[0012] In some embodiments, the dry tableting composition has a water activity of less than 40% relative humidity (R.H.).

[0013] In some embodiments, a gummy-like product is provided. The gummy-like product may include 15-40 wt. % one or more sweeteners; 1-20 wt. % gelatin; 1-15 wt. % cellulose; 0.01-15 wt. % one or more active pharmaceutical ingredients (APIs), therapeutic agents, or supplements; and 25-50 wt. % water.

[0014] In some embodiments, the one or more active pharmaceutical ingredients, therapeutic agents, or supplements in the gummy-like product comprise loratadine, desloratadine, azelastine hydrochloride, pseudoephedrine hydrochloride, phenylephrine bitartrate, doxylamine succinate, acetaminophen, naproxen sodium, ibuprofen, diphenhydramine hydrochloride, guaifenesin, chlorpheniramine maleate, calcium carbonate, calcium citrate, ascorbic acid, vitamins, minerals, pharmaceutically acceptable salts thereof, or combinations thereof.

[0015] In some embodiments, the one or more sweeteners in the in the gummy-like product comprise one or more of compressible sugar, sucrose, fructose, corn syrup, sorbitol, maltitol, xylitol, isomaltitol, mannitol, or erythritol.

[0016] In some embodiments, the gummy-like product may include 0.01-1 wt. % one or more of citric acid anhydrous, citric acid, tartaric acid, tartaric acid anhydrous, ascorbic acid, or ascorbic acid anhydrous.

[0017] In some embodiments, a method for preparing a gummy-like product is provided. The method may include: preparing a dry tablet from a composition comprising one or more sweeteners, gelatin, cellulose, and one or more active pharmaceutical ingredients, therapeutic agents, or supplements using tablet compression; and hydrating the dry tablet to form a gummy-like product.

[0018] In some embodiments, the dry tablet is prepared using a composition comprising: 30-60 wt. % one or more sweeteners; 5-40 wt. % gelatin; 10-20 wt. % cellulose; and 0.01-30 wt. % one or more active pharmaceutical ingredients (APIs), therapeutic agents, or supplements.

[0019] In some embodiments, preparing the dry tablet comprising one or more sweeteners, gelatin, cellulose, and one or more APIs, therapeutic agents, or supplements using tablet compression comprises mixing the one or more sweeteners, the gelatin, the cellulose, and the one or more APIs, therapeutic agents, or supplements to form a mixture.

[0020] In some embodiments, the method includes compressing the mixture into a dry tablet using a tablet compression machine.

[0021] In some embodiments, hydrating the tablet to form a gummy-like product comprises placing the tablet in a coating pan chamber, wherein the coating pan chamber has a temperature of 50-70°C and 50-75% relative humidity.

[0022] In some embodiments, a gummy-like product can be prepared by hydrating a tablet formed from the following dry tableting composition: 30-60 wt. % one or more sweeteners; 5-40 wt. % gelatin; 10-20 wt. % cellulose; and 0.01-30 wt. % one or more active pharmaceutical ingredients (APIs), therapeutic agents, or supplements.

[0023] In some embodiments, a method for treating allergies is provided, the method comprising administering a gummy-like product of any of the embodiments described herein to a human in need thereof, wherein the API, therapeutic agent, or supplement comprises loratadine, desloratadine, phenylephrine, pseudoephedrine, pharmaceutically acceptable salts thereof, or combinations thereof.

[0024] In some embodiments, a method for treating pain is provided, the method comprising administering a gummy-like product of any of the embodiments described herein, to a human in need thereof, wherein the API, therapeutic agent, or supplement comprises one or more of acetaminophen, ibuprofen, naproxen, pharmaceutically acceptable salts thereof, or combinations thereof.

[0025] In some embodiments, a method for treating a vitamin deficiency is provided, the method comprising administering a gummy-like product of any of the embodiments described herein, to a human in need thereof, wherein the API, therapeutic agent, or supplement comprises calcium carbonate, calcium citrate, ascorbic acid, pharmaceutically acceptable salts thereof, or combinations thereof.

[0026] In some embodiments, a method for treating a cough is provided, the method comprising administering a gummy-like product of any of the embodiments herein, to a human in need thereof, wherein the API, therapeutic agent, or supplement comprises dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, chlorpheniramine maleate, phenylephrine bitartrate, pseudoephedrine hydrochloride, pharmaceutically acceptable salts thereof, or combinations thereof.

[0027] In some embodiments, any one or more of the features, characteristics, or elements discussed above with respect to any of the embodiments may be incorporated into any of the other embodiments mentioned above or described elsewhere herein.

[0028] Additional advantages will be readily apparent to those skilled in the art from the following detailed description. The aspects and descriptions herein are to be regarded as illustrative in nature and not restrictive.

[0029] All publications, including patent documents, scientific articles and databases, referred to in this application are incorporated by reference in their entirety for all purposes to the same extent as if each individual publication were individually incorporated by reference. If a definition set forth herein is contrary to or otherwise inconsistent with a definition set forth in the patents, applications, published applications and other publications that are herein incorporated by reference, the definition set forth herein prevails over the definition that is incorporated herein by reference.BRIEF DESCRIPTION OF THE FIGURES

[0030] FIG. 1 shows a flow chart of a tablet compression process, according to some embodiments.

[0031] FIG. 2 shows a process for hydrating tablets using a salt water bath technique, according to some embodiments.

[0032] FIG. 3A shows gummy-like products prepared using a salt water bath technique, according to some embodiments.

[0033] FIG. 3B shows a close-up view of a gummy-like product from FIG. 3A, according to some embodiments.

[0034] FIG. 3C shows a close-up transverse section of a gummy-like product from FIG. 3A, according to some embodiments.

[0035] FIG. 4 shows a process for hydrating tablets using a coating pan and steamer, according to some embodiments.

[0036] FIG. 5A shows an image of tablets that have been hydrated using steam in a coating pan, according to some embodiments.

[0037] FIG. 5B shows an image of hydrated tablets (i.e., a gummy-like product) with some sticking after hydration using a coating pan hydration technique, according to some embodiments.

[0038] FIG. 5C shows a close-up view of gummy-like products that have been hydrated using a coating pan hydration technique, according to some embodiments.

[0039] FIG. 6 shows the hydration of tablets into gummy-like products using a coating pan hydration technique, according to some embodiments.DETAILED DESCRIPTION

[0040] Provided herein are dosage forms having a gummy-like consistency, and methods of manufacturing. The solid gummy-like dosage forms described herein are prepared using tableting techniques. Using tableting techniques can minimize the amount of equipment required, sincespecific gummy production equipment is not required, and manufacturing facilities may be more likely to have tableting equipment on hand. Further, using tableting techniques can provide a more stream-lined and efficient process. Accordingly, the methods and processes for preparing the gummy-like products or dosage forms, by utilizing tableting techniques, bypass complicated cooking processes that require high heat, which is typically used when producing gummy and gummy-like products. Bypassing these cooking processes prevent drug degradation, provide more accurate dosages, and can also provide cost savings by being able to utilize established tablet compression equipment and not specialized equipment that is usually required for conventional gummy manufacturing processes.

[0041] Specifically, the methods for preparing solid dosage forms comprising a gummy-like consistency can include compressing a dry tableting composition comprising sweetener, gelatin, and cellulose into a tablet, and subsequently hydrating the tablet. The compressed dry tablet may be hydrated using any one of several hydration techniques such as those described herein. After hydration, the resulting product is a gummy-like solid dosage form that melts or disintegrates in the oral cavity when in contact with saliva and / or with mild chewing.

[0042] Below are detailed descriptions of compositions used to prepare compressed dry tablets, the compressed dry tablets comprising the compositions before hydration, as well as gummy-like solid dosage forms formed from the hydration of the compressed dry tablets, and processes for preparing the gummy-like solid dosage forms.Compositions for Forming Tablets Used to Prepare Solid Gummy-Like Dosage Forms

[0043] Described below are exemplary dry tableting compositions comprising one or more of gelatin, cellulose, a sweetener, an acid, and a flavor. Using cellulose may improve the hydration of gelatin and thus may improve the formation of gummies from the dry tableting compositions. In some embodiments, the composition may also comprise a therapeutic agent, supplement, active pharmaceutical ingredient, or the like. The dry tableting compositions described below may be compressed into dry tablets that can then be hydrated to form a gummy-like product.Moisture Content

[0044] As mentioned, the compositions described herein are for dry tableting compositions that can be compressed into dry tablets. The moisture content of the dry tableting compositions and the compressed dry tablets should be kept as low as possible because excess moisture makes it more difficult to compress the dry tableting compositions into tablet form. As used herein, a “dry” tableting composition and / or “dry” compressed tablet means that 1) the composition and / or compressed tablets have a water activity, i.e. a moisture content of less than 40% relative humidity (R.H.) and 2) fluid and / or semi-solid ingredients like com syrup, melted gelatin, etc. are not present in the dry tableting compositions or dry compressed tablet composition before it is hydrated into the gummy-like product. Water activity, i.e. moisture content, can be measured using the instrument Hygrolab Cl bench-top indicator from Rotronic. In some embodiments, the dry tableting compositions and / or the dry compressed tablets may have a water activity, i.e. a moisture content, of less than or equal to 40%, 35%, 30%, 25%, 20%, 15%, 10%, 5%, or 1% R.H. In some embodiments, the dry tableting compositions and / or the dry compressed tablets may have a water activity, i.e. a moisture content, of greater than or equal to 35%, 30%, 25%, 20%, 15%, 10%, 5%, or 1% R.H.Active Pharmaceutical Ingredient, Therapeutic Agent, and / or Supplement

[0045] In some embodiments, a dry tableting composition described herein may comprise one or more active pharmaceutical ingredients (APIs), therapeutic agents, or nutritional, vitamin and mineral supplements. In some embodiments, a dry tableting composition may comprise 0.01-30 wt.% API, therapeutic agent, and / or supplement. In some embodiments, a composition may comprise less than or equal to 30, 25, 20, 15, 10, 5, 4, 3, 2, 1, 0.5, or 0.1 wt. % API, therapeutic agent, and / or supplement. In some embodiments, a composition may comprise greater than or equal to 0.01, 0.1, 0.5, 1, 2, 3, 4, 5, 10, 15, 20, or 25 wt. % API, therapeutic agent, and / or supplement. In some embodiments, the API, therapeutic agent, and / or supplement comprises, for example, loratadine, desloratadine, azelastine hydrochloride, pseudoephedrine hydrochloride, phenylephrine bitartrate, doxylamine succinate, acetaminophen, naproxen sodium, ibuprofen, diphenhydramine hydrochloride, guaifenesin, chlorpheniramine maleate, nutritional ingredients such as calcium carbonate, calcium citrate, ascorbic acid, other vitamins, or pharmaceutically acceptable salts thereof.Gelatin

[0046] Dry tableting compositions described herein may comprise 5-40, 10-20, 20-40, 15-25, or 18- 22 wt. % gelatin. In some embodiments, a dry tableting composition comprises less than or equal to 40, 35, 30, 25, 20, 18, 15, or 10 wt. % gelatin. In some embodiments, a dry tableting composition comprises greater than or equal to 5, 10, 15, 18, 20, 25, 30, or 35 wt. % gelatin. Too much gelatin in a dry tableting composition may achieve a gummy-like product that is tougher or not as easily meltable in the oral cavity. Too little gelatin in a dry tableting composition may achieve a gummy- like product lacking structure and / or one that is too watery. The gelatin may be pig-derived. A suitable gelatin may include Bloom 250 porkskin gelatin type A (40 mesh). In some embodiments, the gelatin in the dry tableting composition may comprise a vegan substitute. For example, suitable vegan substitutes may include agar, carrageenan, modified starch, alginate, or pectin. In some embodiments, the amount of gelatin to be added may vary, and the amount of sweetener needed may be increased or decreased depending on the amount of gelatin added. An increase in gelatin may result in an increase in the amount of sweetener needed, while a decrease in gelatin may result in a decrease in the amount of sweetener needed.Sweetener

[0047] Dry tableting compositions described herein may comprise 30-60, 50-90, 70-80, or 65-75 wt. % sweetener. In some embodiments, a dry tableting composition may comprise less than or equal to 70, 65, 60, 55, 50, 45, 40, or 35 wt. % sweetener. In some embodiments, a dry tableting composition may comprise greater than or equal to 30, 35, 40, 45, 50, 55, 60, or 65 wt. % sweetener. Suitable sweeteners can include, but are not limited to, compressible sugar, sucrose, fructose, com syrup, sorbitol (Neosorb Pl 10), maltitol, xylitol, isomaltitol, mannitol, and / or erythritol.Cellulose

[0048] In some embodiments, a dry tableting composition described herein may comprise cellulose. In some embodiments, a dry tableting composition may comprise 5-15 wt.% cellulose or 10-20 wt. % cellulose. In some embodiments, a dry tableting composition may comprise less than or equal to 20, 19, 18, 17, 16, 15, 14, 13, 12, or 11 wt. % cellulose. In some embodiments, a dry tableting composition may comprise greater than or equal to 10, 11, 12, 13, 14, 15, 16, 17, 18, or 19 wt. %cellulose. A suitable cellulose may include, but is not limited to, hydroxyethylcellulose (Natrosol 250 HHX, product code: 414464).Acid

[0049] In some embodiments, a dry tableting composition may comprise 0.1 to 3 wt. % one or more acids. In some embodiments, a dry tableting composition may comprise less than or equal to 3, 2.5, 2, 1.5, 1, or 0.5 wt. % one or more acids. In some embodiments, a dry tableting composition may have greater than or equal to 0.1 , 0.5, 1 , 1 .5, 2, or 2.5 wt. % one or more acids. In some embodiments, the acid may be used to provide flavor to the gummy-like product. In some embodiments, the acid may also be used as a preservative. Suitable acids may include, but are not limited to, citric acid, citric acid anhydrous, tartaric acid, tartaric acid anhydrous, ascorbic acid, ascorbic acid anhydrous, etc.Flavors

[0050] Dry tableting compositions provided herein may comprise one or more flavors. In some embodiments, a dry tableting composition may comprise 0.1-5 wt. % flavor. In some embodiments, a dry tableting composition may comprise less than or equal to 5, 4.5, 4, 3.5, 3, 2.5, 2, 1.5, 1, or 0.5 wt. % flavor. In some embodiments, a dry tableting composition may comprise greater than or equal to 0.1, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, or 4.5 wt. % flavor. A suitable flavor can include Evospray orange flavor or any other flavor that is desired in the gummy-like product.Colorant

[0051] In some embodiments, a dry tableting composition described herein may comprise a colorant. Because gelatin is a clear substance, adding a colorant is a way to customize and develop a more appealing gummy-like product. In some embodiments, a dry tableting composition may comprise 0.001-5 or 0.001-0.1 wt. % colorant. In some embodiments, a dry tableting composition may comprise less than or equal to 5, 4, 3, 2, 1, 0.1, or 0.01 wt. % colorant. In some embodiments, a dry tableting composition may comprise greater than or equal to .001, 0.01, 0.1, 1, 2, 3, or 4 wt. % colorant. A suitable colorant can include FD & C Yellow No. 6 dye or any other food dye.Examples of Compositions that May be Used to Prepare Solid Gummy-Like Dosage Forms

[0052] Table 1 below shows an exemplary dry tableting composition, according to some embodiments. Note that this composition does not comprise an active pharmaceutical ingredient, therapeutic agent, or supplement, but in some embodiments, an active pharmaceutical ingredient, therapeutic agent, or supplement may be included, as described above.Table 1.

[0053] Note that, unlike traditional gummies, the gummy-like products provided herein do not directly mix the gelatin with water. Instead, a dry tablet is formed using a tableting compression technique, and then the dry tablet is hydrated with water to form the gummy-like product.Solid Gummy-Like Dosage Forms

[0054] The dry tableting compositions described above can be compressed into tablet form. The compressed dry tablets can then be hydrated with water to form a gummy-like final product. Asmentioned, including cellulose in the dry tableting composition may improve the hydration of gelatin and thus may improve the formation of the gummy-like product. The gummy-likc product melts in the oral cavity when in contact with saliva and / or with mild chewing. Described below are compositions of solid gummy-like dosage forms formed from hydrating a dry tablet according to the compositions described above.Active Pharmaceutical Ingredient, Therapeutic Agent, and / or Supplement

[0055] In some embodiments, a gummy-like product described herein may comprise one or more active pharmaceutical ingredients (APIs), therapeutic agents, or nutritional, vitamin, or mineral supplements. The API is water-stable or in a form that is water stable, meaning that the API is stable (does not degrade) in the presence of water added during the hydration step. In some embodiments, a gummy-like product may comprise 0.01-15, 0.1-2, or 0.05-4 wt.% API, therapeutic agent, and / or supplement. In some embodiments, a composition may comprise less than or equal to 15, 13, 11, 9, 7, 8, 7, 6, 5, 4, 3, 2, 1, 0.5, 0.1, or 0.05 wt. % API, therapeutic agent, and / or supplement. In some embodiments, a composition may comprise greater than or equal to 0.01, 0.05, 0.1, 0.5, 1, 2, 3, 4, 5, 7, 9, 11, or 13 wt. % API, therapeutic agent, and / or supplement. In some embodiments, the API, therapeutic agent, and / or supplement comprises loratadine, desloratadine, azelastine hydrochloride, pseudoephedrine hydrochloride, phenylephrine bitartrate, doxylamine succinate, acetaminophen, naproxen sodium, ibuprofen, diphenhydramine hydrochloride, guaifenesin, chlorpheniramine maleate, nutritional ingredients such as calcium carbonate, calcium citrate, ascorbic acid, other vitamins, minerals, or pharmaceutically acceptable salts thereof.Water

[0056] As explained herein, water is added to a composition during a hydration step to form a final gummy-like product. In some embodiments, the gummy-like product may comprise 25-50 wt. % water. In some embodiments, the gummy-like product may comprise less than or equal to 50, 45, 40, 35, or 30 wt. % water. In some embodiments, the gummy-like product may comprise greater than or equal to 25, 30, 35, 40, or 45 wt. % water.Gelatin

[0057] Gummy-like products described herein may comprise 1-20 wt. % gelatin. In some embodiments, a gummy-like product comprises less than or equal to 20, 18, 16, 14, 12, 10, 8, 6, 4, or 2 wt. % gelatin. In some embodiments, a gummy-like product comprises greater than or equal to 1, 3, 5, 7, 9, 11, 13, 15, 17, or 19 wt. % gelatin. Too much gelatin in a gummy-like product may cause the product to be tougher or not as easily meltable in the oral cavity. Too little gelatin in a gummy-like product may achieve a product lacking structure and / or one that is too watery. The gelatin may be pig-derived. A suitable gelatin may include Bloom 250 porkskin gelatin type A (40 mesh). In some embodiments, a gummy-like product may comprise a vegan substitute for gelatin. For example, suitable vegan substitutes may include agar, carrageenan, modified, starch, alginate, or pectin.Sweetener

[0058] Gummy-like products described herein may comprise 15-40, 10-90, 30-55, or 50-75 wt. % sweetener. In some embodiments, a gummy-like product may comprise less than or equal to 40, 35, 30, 25, or 20 wt. % sweetener. In some embodiments, a gummy-like product may comprise greater than or equal to 15, 20, 25, 30, or 35 wt. % sweetener. Suitable sweeteners can include, but are not limited to, compressible sugar, sucrose, fructose, com syrup, sorbitol, maltitol, xylitol, isomaltitol, mannitol, and / or erythritol.Cellulose

[0059] In some embodiments, a composition described herein may comprise cellulose. In some embodiments, a composition may comprise 1-15 wt.% cellulose. In some embodiments, a composition may comprise less than or equal to 2, 4, 6, 8, 10, 12, 14, or 16 wt. % cellulose. In some embodiments, a composition may comprise greater than or equal to 1 , 3, 5, 7, 9, 11 , 13, or 15 wt. % cellulose. A suitable cellulose may include, but is not limited to, hydroxyethylcellulose (Natrosol 250 HHX, product code: 414464).Acid

[0060] In some embodiments, a gummy-like product according to embodiments described herein may comprise 0.01-0.1 wt. % acid. In some embodiments, a gummy-like product may comprise less than or equal to 0.1, 0.09, 0.08, 0.07, 0.06, 0.05, 0.04, 0.03, or 0.02 wt. % acid. In some embodiments, a gummy-like product may have greater than or equal to 0.01 % acid. In some embodiments, the acid may be used to provide flavor to the gummy-like product. Suitable acids may include, but are not limited to, citric acid, citric acid anhydrous, tartaric acid, tartaric acid anhydrous, ascorbic acid, ascorbic acid anhydrous, etc.Flavors

[0061] Gummy-like products provided herein may comprise one or more flavors. In some embodiments, a gummy-like product may comprise 0.01-3 wt. % flavor. In some embodiments, a gummy-like product may comprise less than or equal to 3, 2.5, 2, 1.5, 1, 0.5, 0.4, 0.3, 0.2, 0.1 or 0.05wt. % flavor. In some embodiments, a composition may comprise greater than or equal to 0.01, 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, 1, 1.5, 2, or 2.5 wt. % flavor. A suitable flavor can include, but is not limited to, Evospray orange flavor or any other desirable flavor.Colorant

[0062] In some embodiments, a gummy-like product described herein may comprise a colorant. Because gelatin is a clear substance, adding a colorant is a way to customize and develop a more appealing gummy-like product. In some embodiments, a gummy-like product may comprise 0.001- 0.1 wt. % colorant. In some embodiments, a gummy-like product may comprise less than or equal to 0.1, 0.01, 0.009, 0.008, 0.007, 0.006, 0.005, 0.004, 0.003, or 0.002 wt. % colorant. In some embodiments, a gummy-like product may comprise greater than or equal to 0.001, 0.002, 0.003, 0.004, 0.005, 0.006, 0.007, 0.008, 0.009, or 0.1 wt. % colorant. A suitable colorant can include FD & C Yellow No. 6 dye or any other food dye.Methods of Manufacturing Gummy-Like Products

[0063] Discussed below are processes for preparing the gummy-like products described herein. As described in detail below, a tablet is first prepared using a tablet compression process. Then, thecompressed dry tablet is hydrated using one of various hydration techniques. By adding water during the hydration process, the compressed dry tablet (which comprises gelatin) assumes a gummy-like consistency.Tablet Compression

[0064] In some embodiments, the compressed dry tablets are formed using tablet compression techniques on any suitable tableting machine. The compressed dry tablets may be formed from the dry tableting compositions described above. FIG. 1 shows an example flow chart of the tablet compression process 100. In step 102, each component of a dry tablet composition is measured or weighed. At step 104, the weighed components are mixed together. At step 106, the dry tableting composition is compressed into dry tablets using a tablet compression machine.

[0065] Optionally, prior to step 106, the mixed components of the composition can be granulated using a granulation process. A dry granulation process may be used to improve flowability of powdered ingredients by increasing particle size. During dry granulation, powders may compressed or compacted and milled to achieve the desired properties. Granulation may also be accomplished using wet granulation, in which liquid binders are added to the powder to reach the desired granulation size and that is then dried.

[0066] Any suitable tablet compression machine may be used to compress the dry granulated composition into dry tablets. For example, the tablet compression machine may be a Flexitab tableting machine. The tablet compression machine may be a Piccola multistation tablet press. In some embodiments, the tablet compression machine may be externally coated with a lubricant to prevent the tablets from sticking during compression. In some embodiments, the lubricant may be a Capol lubricant. In some embodiments, the lubricant may be magnesium stearate.

[0067] In some embodiments, a compressed dry tablet may have a hardness of about 1 .0, about 1 .25, about 1.5, about 1.75, about 2.0, about 2.25, about 2.5, about 2.75, about 3.0, about 3.25, about 3.5, about 3.75, about 4.0, about 4.25, about 4.5, about 4.75, about 5.0, about 5.25, about 5.5, about 5.75, or about 6.0 kP. In some embodiments, the compressed dry tablet may have a hardness of about 3.15 to, and including, about 3.85 kP. In a particular embodiment, the compressed dry tablet may have a hardness of about 3.5. In some embodiments, a compressed dry tablet may have a hardness of lessthan or equal to 6.0, 5.5, 5, 4.5, 4, 3.5, 3, 2.5, 2, or 1.5 kP. In some embodiments, a compressed dry tablet may have a hardness of greater than or equal to 1.0, 1.25, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5, or 5.5 kP. The hardness of the compressed dry tablets and / or the gummy-like products described herein can be measured using any standard tablet hardness tester.Hydration

[0068] After forming compressed dry tablets using a tablet compression process, such as that discussed above and depicted in FIG. 1 , the compressed dry tablets are then hydrated to form a gummy-like product. As described below, there are various hydration techniques through which this might be achieved.Salt Water Bath Hydration Technique

[0069] FIG. 2 shows a process for hydrating the compressed dry tablets using a salt water bath. In some embodiments, the use of a salt water bath technique may be useful to identify the environmental conditions at which the dry tablets may be optimally hydrated. At step 202, compressed dry tablets may be formed using a tablet compression process, such as that depicted in FIG. 1 and discussed above. At step 204, the compressed dry tablets may be placed in silicone molds. The silicone molds may be any of various shapes and sizes. In some embodiments, each silicone mold comprises a single compressed dry tablet. In some embodiments, the silicone molds may be open (i.e. uncovered) such that the compressed dry tablets are exposed to the surrounding environment.

[0070] The open silicone molds (comprising the compressed dry tablets) may be placed on a raised platform above a saturated salt water bath at step 206, such that the silicone molds do not come into direct contact with the salt water. The salt water bath may be used to more easily regulate the environmental conditions, such as the target temperature and humidity described above, to aid in the hydration of the tablets. In some embodiments, the salt water bath may be located inside a closed desiccator, such that the silicone molds are open to the conditions inside the desiccator but are closed off from conditions external to the closed desiccator to further regulate the environmental conditions as the compressed dry tablets are hydrated. In some embodiments, the silicone molds are exposed to a temperature of 60°C and 75% relative humidity within the desiccator. In someembodiments, the silicone mold may remain above the salt water bath in the desiccator for approximately 48 hours.

[0071] In some embodiments, the silicone molds may be exposed to a temperature of 50-100 degrees Celsius. In some embodiments, the silicone molds may be exposed to a temperature of 100, 95, 90, 85, 80, 75, 70, 65, 60, or 55 degrees Celsius. In some embodiments, the silicone molds may be exposed to a temperature of greater than or equal to 50, 55, 60, 65, 70, 75, 80, 85, 90, or 95 degrees Celsius. In some embodiments, the silicone molds may be exposed to air having 50-100% relative humidity. In some embodiments, the silicone molds may be exposed to air having less than or equal to 100, 95, 90, 85, 80, 75, 70, 65, 60, or 55 % relative humidity. In some embodiments, the silicone molds may be exposed to air having greater than or equal 50, 55, 60, 65, 70, 75, 80, 85, 90, or 95 % relative humidity. In some embodiments, the amount of salt to be added to the salt water bath may be adjusted depending on the size of the salt water bath and / or desiccator chamber and the desired temperature and relative humidity to be achieved.

[0072] In some embodiments, the silicone mold may remain above the salt water bath for 6-144 or 42-54 hours. In some embodiments, the silicone mold may remain above the salt water bath for less than or equal to 144, 138, 132, 126, 120, 114, 108, 102, 96, 90, 84, 78, 72, 66, 60, 54, 48, 42, 36, 30, 24, 18, or 12 hours. In some embodiments, the silicone mold may remain above the salt water bath for greater than or equal to 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126, 132, or 138 hours. At step 208, the molds are removed from the platform above the salt water bath and the gummy-like product may be removed from the silicone molds.

[0073] FIG. 3A shows gummy-like products prepared using a salt water bath technique, such as that depicted in FIG. 2 and described above. As shown, the gummy-like products of FIG. 3A are of various shapes and sizes depending on the shape and size of the mold that was used. Additionally, the gummy-like products have a translucent character. FIG. 3B shows a close-up view of a gummy- like product from FIG. 3A. FIG. 3C shows a close-up transverse section of a gummy-like product from FIG. 3A. As shown in the image of FIG. 3C, no residue or precipitation is presented in the gummy-like product.Coating Pan Hydration Technique

[0074] FIG. 4 shows a process 400 for hydrating compressed dry tablets using a coating pan with a steamer. In some embodiments, the compressed dry tablets hydrated using the coating pan process 400 depicted in FIG. 4 may be prepared using a tablet compression process, such as that depicted in FIG. 1. In some embodiments, the coating pan used is a Labcoat by O’Hara.

[0075] In this example, compressed dry tablets were foimed from the composition described in Table 4 above. At step 402, the compressed dry tablets may be placed in the perforated coating pan. The coating pan may be sealed within a chamber to contain the humidity. In some embodiments, the compressed dry tablets are spherical shaped compressed dry tablets that weigh 250mg. In some embodiments, the compressed dry tablets weigh 100-500 mg. In some embodiments, the compressed dry tablets weigh less than or equal to 500, 450, 400, 350, 300, 250, 200, or 150 mg. In some embodiments, the compressed dry tablets weight greater than or equal to 100, 150, 200, 250, 300, 350, 400, or 450 mg. The temperature of the coating pan chamber may be 40-80 degrees Celsius. In some embodiments, the temperature of the coating pan chamber may be 50-70 degrees Celsius. In some embodiments, the temperature of the coating pan chamber may be less than or equal to 80, 75, 70, 65, 60, 55, 50, or 45 degrees Celsius. In some embodiments, the temperature of the coating pan chamber may be greater than or equal to 40, 45, 50, 55, 60, 65, 70, or 75 degrees Celsius.

[0076] At step 404, steam may be introduced into the chamber of the perforated coating pan. In some embodiments, steam may be introduced when a temperature of approximately 60 degrees Celsius within the chamber is achieved. Steam may be used to hydrate the compressed dry tablets, and introducing steam while the coating pan is at a high temperature can aid in the hydration process. In some embodiments, steam is introduced into the coating pan when a temperature of about 50-70 degrees Celsius within the chamber is achieved. In some embodiments, steam is introduced into the coating pan when a temperature of less than or equal to about 80, 75, 70, 65, 60, or 55 degrees Celsius within the chamber is achieved. In some embodiments, steam is introduced into the coating pan when a temperature of greater than or equal to about 50, 55, 60, 65, 70, or 75 degrees Celsius is achieved within the chamber. In some embodiments, the steam that is introduced into the chamber has a temperature of greater than or equal to 100 degrees Celsius.

[0077] In some embodiments, after the tablets are sprayed with steam, the tablets may be dried. Small-scale batches of tablets may be dried with a hot air fan or a portable dryer, such as a hair dryer, for example. In some embodiments, the dryer may be a 1,500 to 2,000 watt dryer. In some embodiments, large-scale batches of tablets may be dried with any suitable tablet drying machine. The tablets may be sprayed with steam and dried over multiple cycles, such that step 404 may be repeated multiple times until a hydrated, gummy-like product is achieved.

[0078] FIG. 5A shows an image of tablets that have been hydrated using steam in a coating pan. As shown, the tablets exhibit some sticking to one another after wetting / hydration. FIG. 5B shows another image of the hydrated tablets of gummy-like product with some sticking after hydration using steam in a coating pan. FIG. 5C shows a close-up view of sticking gummy-like products that have been hydrated using steam in a coating pan.

[0079] One reason for the sticking shown in FIG. 5C could be that the dry tableting compositions used in this example did not contain cellulose. The addition of cellulose to the dry tableting composition can help improve the hydration of gelatin into a gummy-like product, which can help prevent the gummy-like products from sticking together. FIG. 6 shows an image of gummy-like products 608 that were produced from a dry-tableting composition that includes cellulose. As shown, the hydrated gummy-like products exhibited less sticking and clumping.

[0080] In some embodiments, the steps of a method 600 for hydrating a gummy-like product from a dry tableting composition that includes cellulose may be the same as, or similar to, those shown in FIGS. 5A-5C. At step 602, steam from a steamer was sprayed onto the tablets in a coating pan chamber. At step 604, excess moisture was dried by blowing the partially hydrated tablets with hot air from a fan while the tablets remained in the coating pan chamber. Step 606 shows the partially hydrated tablets, which are now darker in color from the hydrated dye. Steps 602 and 604 can be repeated until a fully hydrated gummy-like product is achieved, shown in 608.Methods for Treating

[0081] In some embodiments, provided herein are methods for treating one or more health conditions comprising administering a pharmaceutical composition described herein. In some embodiments, methods are provided for treating allergies (e.g., hay fever, hives, conjunctivitis andreactions to insect bites or stings), the method comprising administering to a patient a gummy-like product comprising a decongestant, an antihistamine, or a combination of both, such as loratadine, desloratadine, phenylephrine, pseudoephedrine, or a pharmaceutically acceptable salt thereof. In some embodiments, provided herein are methods for treating or supplementing one or more vitamin or nutrient deficiencies comprising administering to a patient a gummy-like product comprising, for example, calcium carbonate, calcium citrate, ascorbic acid, or other nutritional or vitamin supplements.

[0082] In some embodiments, provided herein are methods for treating pain comprising administering to a patient a gummy-like product comprising an analgesic, for example, acetaminophen, ibuprofen, naproxen, a pharmaceutically acceptable salt thereof, and combinations thereof. In some embodiments, provided herein are methods for treating cough or cold, comprising administering to a patient a gummy-like product comprising an antitussive, an expectorant, a decongestant, and combinations thereof, such as dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, chlorpheniramine maleate, phenylephrine bitartrate, pseudoephedrine hydrochloride, or a pharmaceutically acceptable salt thereof. In some embodiments, provided herein are methods for treating a combination of two or more health conditions, including allergies, vitamin or nutrient deficiencies, pain, cough and cold comprising administering to a patient a gummy-like product comprising one or more APIs, therapeutic agents, or nutritional or vitamin supplements.

[0083] The foregoing description sets forth exemplary systems, methods, techniques, parameters, and the like. It should be recognized, however, that such description is not intended as a limitation on the scope of the present disclosure but is instead provided as a description of exemplary embodiments.

[0084] Although the description herein uses terms first, second, etc. to describe various elements, these elements should not be limited by the terms. These terms are only used to distinguish one element from another.EXAMPLESExample 1: Composition Comprising Cellulose Used to form Gummy-Like ProductExample 2: Composition used to form Gummy-Like Product; Batch size 1 kgExample 3: Forming Gummy-Like Products Using a Salt Water Bath Hydration Technique

[0085] A dry tableting composition was prepared in accordance with the composition outlined inExample 2. A Flexitab tableting machine was used with tooling 17.4 mm round ‘b’ tooling (A-2-21).The compression settings were force at 42 kN and fill weight setting at 8.9mm. The initial tablet hardness was found to be 9.7 kP. All tablets were dusted using a vacuum cleaner to remove the excess magnesium stearate on the tablet surface. The tablets were then hydrated using a salt water bath in a desiccator and maintained at 60 degrees Celsuis / 75% relative humidity for about two days. The gummy-like products prepared in this example are shown in FIG. 3.Example 4: Forming Gummy-Like Products Using a Coating Pan Hydration Technique

[0086] A dry tableting composition was prepared in accordance with the composition outlined in Example 2. Spherical-shaped dry compressed tablets (about 250 mg tablet weight) were hydrated using an O’Hara Labcoat coating pan. The coating pan chamber temperature was about 50 degrees Celsius. Steam from a steamer was sprayed into the coating pan chamber. The tablets were hydrated in the coating pan chamber while a temperature of about 50 degrees Celsius and 60% relative humidity was maintained in the coating pan chamber. The gummy-like products prepared in this example are shown in FIG. 5C. This Example was then repeated with the composition outlined in Example 1, with the gummy-like products shown in FIG. 6.DEFINITIONS

[0087] Unless defined otherwise, all terms of art, notations and other technical and scientific terms or terminology used herein are intended to have the same meaning as is commonly understood by one of ordinary skill in the art to which the claimed subject matter pertains. In some cases, terms with commonly understood meanings are defined herein for clarity and / or for ready reference, and the inclusion of such definitions herein should not necessarily be construed to represent a substantial difference over what is generally understood in the art.

[0088] Reference to “about” a value or parameter herein includes (and describes) variations that are directed to that value or parameter per se. For example, description referring to “about X” includes description of “X”. In addition, reference to phrases “less than”, “greater than”, “at most”, “at least”, “less than or equal to”, “greater than or equal to”, or other similar phrases followed by a string of values or parameters is meant to apply the phrase to each value or parameter in the string of values or parameters.

[0089] As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It is also to be understood that the term “and / or” as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items. It is further to be understood that the terms “includes, “including,” “comprises,” and / or “comprising,” when used herein, specify the presence of stated features, integers, steps, operations, elements, components, and / or units but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, units, and / or groups thereof.

[0090] This application discloses several numerical ranges in the text and figures. The numerical ranges disclosed inherently support any range or value within the disclosed numerical ranges, including the endpoints, even though a precise range limitation is not stated verbatim in the specification because this disclosure can be practiced throughout the disclosed numerical ranges.

[0091] The above description is presented to enable a person skilled in the art to make and use the disclosure and is provided in the context of a particular application and its requirements. Various modifications to the preferred embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the disclosure. Thus, this disclosure is not intended to be limited to the embodiments shown but is to be accorded the widest scope consistent with the principles and features disclosed herein.EMBODIMENTSEmbodiment 1. A dry tableting composition comprising:30-60 wt. % one or more sweeteners;5-40 wt. % gelatin;10-20 wt. % cellulose; and0.01-30 wt. % one or more active pharmaceutical ingredients (APIs), therapeutic agents, or supplements.Embodiment 2. The dry tableting composition of embodiment 1, wherein the one or more APIs, therapeutic agents, or supplements comprise loratadine, desloratadine, azelastine hydrochloride, pseudoephedrine hydrochloride, phenylephrine bitartrate, doxylamine succinate, acetaminophen, naproxen sodium, ibuprofen, diphenhydramine hydrochloride, guaifenesin, chlorpheniramine maleate, calcium carbonate, calcium citrate, ascorbic acid, vitamins, minerals, pharmaceutically acceptable salts thereof, or combinations thereof.Embodiment 3. The dry tableting composition of embodiment 1 or 2, wherein the one or more sweeteners comprise one or more of compressible sugar, sucrose, fructose, com syrup, sorbitol, maltitol, xylitol, isomaltitol, mannitol, or erythritol.Embodiment 4. The dry tableting composition of any of embodiments 1-3, comprising 0.1-3 wt. % one or more of citric acid anhydrous, citric acid, tartaric acid, tartaric acid anhydrous, ascorbic acid, or ascorbic acid anhydrous.Embodiment 5. The dry tableting composition of any of embodiments 1-4, wherein the dry tableting composition has a water activity of less than 40% relative humidity (R.H.).Embodiment 6. A gummy-like product comprising:15-40 wt. % one or more sweeteners;1-20 wt. % gelatin;1-15 wt. % cellulose;0.01-15 wt. % one or more active pharmaceutical ingredients (APIs), therapeutic agents, or supplements; and25-50 wt. % water.Embodiment 7. The gummy-like product of embodiment 6, wherein the one or more active pharmaceutical ingredients, therapeutic agents, or supplements comprise loratadine, desloratadine, azelastine hydrochloride, pseudoephedrine hydrochloride, phenylephrine bitartrate, doxylamine succinate, acetaminophen, naproxen sodium, ibuprofen, diphenhydramine hydrochloride, guaifenesin, chlorpheniramine maleate, calcium carbonate, calcium citrate, ascorbic acid, vitamins, minerals, pharmaceutically acceptable salts thereof, or combinations thereof.Embodiment 8. The gummy-like product of embodiments 6 or 7, wherein the one or more sweeteners comprise one or more of compressible sugar, sucrose, fructose, com syrup, sorbitol, maltitol, xylitol, isomaltitol, mannitol, or erythritol.Embodiment 9. The gummy-like product of any of embodiments 6-8, comprising 0.01-1 wt. % one or more of citric acid anhydrous, citric acid, tartaric acid, tartaric acid anhydrous, ascorbic acid, or ascorbic acid anhydrous.Embodiment 10. A method for preparing a gummy-like product, the method comprising: preparing a dry tablet from a composition comprising one or more sweeteners, gelatin, cellulose, and one or more active pharmaceutical ingredients, therapeutic agents, or supplements using tablet compression; and hydrating the dry tablet to form a gummy-like product.Embodiment 11. The method of embodiment 10, wherein the dry tablet is prepared using a composition comprising:30-60 wt. % one or more sweeteners;5-40 wt. % gelatin;10-20 wt. % cellulose; and0.01-30 wt. % one or more active pharmaceutical ingredients (APIs), therapeutic agents, or supplements.Embodiment 12. The method of embodiment 10 or 11, wherein preparing the dry tablet comprising one or more sweeteners, gelatin, cellulose, and one or more APIs, therapeutic agents, or supplementsusing tablet compression comprises mixing the one or more sweeteners, the gelatin, the cellulose, and the one or more APIs, therapeutic agents, or supplements to form a mixture.Embodiment 13. The method of any of embodiments 10-12, comprising compressing the mixture into a dry tablet using a tablet compression machine.Embodiment 14. The method of any of embodiments 10-13, wherein hydrating the tablet to form a gummy-like product comprises placing the tablet in a coating pan chamber, wherein the coating pan chamber has a temperature of 50-70°C and 50-75% relative humidity.Embodiment 15. A gummy-like product prepared by hydrating a tablet formed from the following dry tableting composition:30-60 wt. % one or more sweeteners;5-40 wt. % gelatin;10-20 wt. % cellulose; and0.01-30 wt. % one or more active pharmaceutical ingredients (APIs), therapeutic agents, or supplements.Embodiment 16. A method for treating allergies comprising administering a gummy-like product of any of embodiments 6-9, to a human in need thereof, wherein the API, therapeutic agent, or supplement comprises loratadine, dcsloratadinc, phenylephrine, pseudoephedrine, pharmaceutically acceptable salts thereof, or combinations thereof.Embodiment 17. A method for treating pain comprising administering a gummy-like product of any of embodiments 6-9, to a human in need thereof, wherein the API, therapeutic agent, or supplement comprises one or more of acetaminophen, ibuprofen, naproxen, pharmaceutically acceptable salts thereof, or combinations thereof.Embodiment 18. A method for treating a vitamin deficiency comprising administering a gummy-like product of any of embodiments 6-9, to a human in need thereof, wherein the API, therapeutic agent, or supplement comprises calcium carbonate, calcium citrate, ascorbic acid, pharmaceutically acceptable salts thereof, or combinations thereof.Embodiment 19. A method for treating a cough comprising administering a gummy-like product of any of embodiments 6-9, to a human in need thereof, wherein the API, therapeutic agent, or supplement comprises dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, chlorpheniramine maleate, phenylephrine bitartrate, pseudoephedrine hydrochloride, pharmaceutically acceptable salts thereof, or combinations thereof.

Claims

CLAIMS1. A dry tableting composition comprising:30-60 wt. % one or more sweeteners;5-40 wt. % gelatin;10-20 wt. % cellulose; and0.01-30 wt. % one or more active pharmaceutical ingredients (APIs), therapeutic agents, or supplements.

2. The dry tableting composition of claim 1, wherein the one or more APIs, therapeutic agents, or supplements comprise loratadine, desloratadine, azelastine hydrochloride, pseudoephedrine hydrochloride, phenylephrine bitartrate, doxylamine succinate, acetaminophen, naproxen sodium, ibuprofen, diphenhydramine hydrochloride, guaifenesin, chlorpheniramine maleate, calcium carbonate, calcium citrate, ascorbic acid, vitamins, minerals, pharmaceutically acceptable salts thereof, or combinations thereof.

3. The dry tableting composition of claim 1 or 2, wherein the one or more sweeteners comprise one or more of compressible sugar, sucrose, fructose, com syrup, sorbitol, maltitol, xylitol, isomaltitol, mannitol, or erythritol.

4. The dry tableting composition of any of claims 1-3, comprising 0.1-3 wt. % one or more of citric acid anhydrous, citric acid, tartaric acid, tartaric acid anhydrous, ascorbic acid, or ascorbic acid anhydrous.

5. The dry tableting composition of any of claims 1-4, wherein the dry tableting composition has a water activity of less than 40% relative humidity (R.H.).

6. A gummy-like product comprising:15-40 wt. % one or more sweeteners;1-20 wt. % gelatin;1-15 wt. % cellulose;0.01-15 wt. % one or more active pharmaceutical ingredients (APIs), therapeutic agents, or supplements; and25-50 wt. % water.

7. The gummy-like product of claim 6, wherein the one or more active pharmaceutical ingredients, therapeutic agents, or supplements comprise loratadine, desloratadine, azelastine hydrochloride, pseudoephedrine hydrochloride, phenylephrine bitartrate, doxylamine succinate, acetaminophen, naproxen sodium, ibuprofen, diphenhydramine hydrochloride, guaifenesin, chlorpheniramine maleate, calcium carbonate, calcium citrate, ascorbic acid, vitamins, minerals, pharmaceutically acceptable salts thereof, or combinations thereof.

8. The gummy-like product of claim 6 or 7, wherein the one or more sweeteners comprise one or more of compressible sugar, sucrose, fructose, corn syrup, sorbitol, maltitol, xylitol, isomaltitol, mannitol, or erythritol.

9. The gummy-like product of any of claims 6-8, comprising 0.01-1 wt. % one or more of citric acid anhydrous, citric acid, tartaric acid, tartaric acid anhydrous, ascorbic acid, or ascorbic acid anhydrous.

10. A method for preparing a gummy-like product, the method comprising: preparing a dry tablet from a composition comprising one or more sweeteners, gelatin, cellulose, and one or more active pharmaceutical ingredients, therapeutic agents, or supplements using tablet compression; and hydrating the dry tablet to form a gummy-like product.

11. The method of claim 10, wherein the dry tablet is prepared using a composition comprising:30-60 wt. % one or more sweeteners;5-40 wt. % gelatin;10-20 wt. % cellulose; and0.01-30 wt. % one or more active pharmaceutical ingredients (APIs), therapeutic agents, or supplements.

12. The method of claim 10 or 11 wherein preparing the dry tablet comprising one or more sweeteners, gelatin, cellulose, and one or more APIs, therapeutic agents, or supplementsusing tablet compression comprises mixing the one or more sweeteners, the gelatin, the cellulose, and the one or more APIs, therapeutic agents, or supplements to form a mixture.

13. The method of any of claims 10-12, comprising compressing the mixture into a dry tablet using a tablet compression machine.

14. The method of any of claims 10-13, wherein hydrating the tablet to form a gummy-like product comprises placing the tablet in a coating pan chamber, wherein the coating pan chamber has a temperature of 50-70°C and 50-75% relative humidity.

15. A gummy-like product prepared by hydrating a tablet formed from the following dry tableting composition:30-60 wt. % one or more sweeteners;5-40 wt. % gelatin;10-20 wt. % cellulose; and0.01-30 wt. % one or more active pharmaceutical ingredients (APIs), therapeutic agents, or supplements.

16. A method for treating allergies comprising administering a gummy-like product of any of claims 6-9, to a human in need thereof, wherein the API, therapeutic agent, or supplement comprises loratadine, desloratadine, phenylephrine, pseudoephedrine, pharmaceutically acceptable salts thereof, or combinations thereof.

17. A method for treating pain comprising administering a gummy-like product of any of claims 6-9, to a human in need thereof, wherein the API, therapeutic agent, or supplement comprises one or more of acetaminophen, ibuprofen, naproxen, pharmaceutically acceptable salts thereof, or combinations thereof.

18. A method for treating a vitamin deficiency comprising administering a gummy-like product of any of claims 6-9, to a human in need thereof, wherein the API, therapeutic agent, or supplement comprises calcium carbonate, calcium citrate, ascorbic acid, pharmaceutically acceptable salts thereof, or combinations thereof.

9. A method for treating a cough comprising administering a gummy-like product of any of claims 6-9, to a human in need thereof, wherein the API, therapeutic agent, or supplement comprises dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, chlorpheniramine maleate, phenylephrine bitartrate, pseudoephedrine hydrochloride, pharmaceutically acceptable salts thereof, or combinations thereof.

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