In SITU preparation of gummy compositions in blister

Abstract

A gelatin-comprising composition is provided herein that includes 1-15 wt. % gelatin, 60-95 wt. % one or more sweetener, and 0.01-10 wt. % one or more active pharmaceutical ingredient (API). Also provided herein is a method of making a gummy composition, including heating a blister containing a gelatin-comprising composition and water external to the gelatin-comprising composition to form a liquid composition in the blister, and allowing the blister to set to form the gummy composition. Also provided herein is a gummy composition generated by the disclosed method, and a blister or blister pack including a gummy composition generated by the disclosed method.

Description

IN SITU PREPARATION OF GUMMY COMPOSITIONS IN BLISTERFIELD

[0001] This disclosure generally relates to a gelatin-comprising composition, a gummy composition generated by hydration of the gelatin-comprising composition in a blister, and methods of generating the gummy composition.BACKGROUND

[0002] This section provides background information related to the present disclosure which is not necessarily prior art.

[0003] Gummy compositions generally include a gelling agent, such as gelatin, and water, to form a thick, gel-like solution, which is placed in an open mold. Along with a gelling agent, gummy compositions typically include sweeteners, starch, acidulants, colors, flavors, water, or a combination thereof. Because gelling agents are usually odorless, tasteless, and colorless, materials such as sweeteners, colors, and flavors are added to make a product that is more palatable and visually appealing. Gummy compositions, for example, are produced as chewable candy / sweets or as dosage forms for therapeutic agents or supplements, such as vitamins.

[0004] To produce a gummy composition, a multi-step process is typically used that includes weighing the ingredients, mixing the ingredients, dissolving the ingredients in water, heating the ingredients until molten, placing the mixture into an open mold, and cooling the molded product. The mixture of a gelling agent in water forms a thick, gel-like solution. This solution is then added to a mold, where the composition is heated and then congealed to form a standard gummy composition. Once the gummy composition is produced, it is expelled from the mold and packaged.

[0005] Despite the commercial availability of methods for generating gummy compositions, there is a need in the art for new and improved methods for streamlining the multi-step process.SUMMARY

[0006] This section provides a general summary of the disclosure and is not a comprehensive disclosure of its full scope or all of its features.

[0007] In certain aspects, the present disclosure provides a gelatin-comprising composition that includes gelatin, one or more sweetener, and one or more active pharmaceutical ingredient (API). In some embodiments, the composition may be a solid oral dosage form, such as a compressed tablet or a powder. In some embodiments, the compressed tablet may have a hardness of about 3.15 kP to about3.85 kP, preferably about 3.5 kP. In some aspects, the gelatin-comprising composition may include about 1-15 wt. % gelatin, preferably about 8 wt. % gelatin. In some embodiments, the gelatincomprising composition may include about 60-95 wt. % of one or more sweetener. In some embodiments, the gelatin-comprising composition may include about 0.1-10 wt. % of one or more API, such as loratadine or acetaminophen. The gelatin-comprising composition may include additional additives, such as one or more preservative, such as citric acid anhydrous and / or a superdisintegrant.

[0008] The present disclosure also provides a method of making a gummy composition by combining the gelatin-comprising composition and water in a blister or blister pack. In some embodiments, the method may include a step for heating a blister that contains water and the gelatincomprising composition, which can undergo a phase change in the blister. In further aspects, the heated gelatin-comprising composition is allowed to set in the blister to form a gummy composition. In some embodiments, the heated gelatin comprising composition may form a liquid composition. In such embodiments, the liquid composition is allowed to set in the blister to form a gummy composition. In some embodiments, the amount of water added to or present in the blister may be about 75% of the gelatin-comprising composition weight. In some embodiments, additional steps may be included, such as placing the gelatin-comprising composition into the blister, adding water to the blister, coating the inside of the blister with a lubricant, sealing the blister with a cover, or a combination thereof. In some aspects, the sealing step may include heating at least a portion of the cover to heat at least a portion of the blister. In some embodiments, the heated gelatin-comprising composition, after the phase change, is allowed to set at room temperature or in a cooler.

[0009] In further aspects, the present disclosure provides a gummy composition generated by the method described herein. Thus, the present disclosure also provides a blister or blister pack that includes a gummy composition generated by the disclosed method.

[0010] Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The drawings described herein arc for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure.

[0012] FIG. 1 is an overview of the process of forming a gummy composition by hydrating a gelatin-comprising tablet in a blister.DETAILED DESCRIPTIONA. Introduction

[0013] In one embodiment, a method of generating a gummy composition by hydration of a gelatin-comprising composition in a blister or blister pack is disclosed herein.

[0014] Although many products are packaged in blisters, no gummy compositions are known to be prepared in a blister. By using conventional and existing tableting equipment (and without the need for gummy-specific production equipment), the manufacturing methods described herein can be more efficient, simpler, and less expensive than conventional gummy manufacturing methods in an open mold. Avoiding the complex gummy-forming process also helps shorten the amount of time it normally takes to generate a gummy composition and does not require a long cooking and setting process. This efficient process allows gummy compositions to be formed in a blister or blister pack itself when gelatin-comprising compositions, such as tablets or powder described herein, come into contact with water, are exposed to heat, and are allowed to set.

[0015] Without being bound by theory, because generating gummy compositions in situ bypasses complicated cooking processes involving high heat, the methods described herein help prevent drug degradation. Conventional gummy-production techniques also pose dose weight accuracy challenges for products comprising therapeutic agents / APls / supplements due to evaporation.

[0016] In another embodiment, a composition comprising gelatin that is hydrated to form a gummy composition in a blister is also described herein. The gelatin-comprising composition, such as a tablet or powder includes a percentage of gelatin, that when hydrated, forms a gummy composition that can melt or disintegrate in the oral cavity when in contact with saliva and / or with mild chewing.

[0017] Example embodiments are provided so that this disclosure will be thorough and will fully convey the scope to those who are skilled in the art. Numerous specific details are set forth, such as examples of specific compositions, components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that example embodiments may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. In some example embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.B. Definitions

[0018] The terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. As used herein, the singular' forms “a,” “an,” and “the” may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms “comprises,” “comprising,” “including,” and “having,” are inclusive and therefore specify the presence of stated features, elements, compositions, steps, integers, operations, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. Although the open-ended term “comprising,” is to be understood as a non-restrictive term used to describe and claim various embodiments set forth herein, in certain aspects, the term may alternatively be understood to instead be a more limiting and restrictive term, such as “consisting of’ or “consisting essentially of.” Thus, for any given embodiment reciting compositions, materials, components, elements, features, integers, operations, and / or process steps, the present disclosure also specifically includes embodiments consisting of, or consisting essentially of, such recited compositions, materials, components, elements, features, integers, operations, and / or process steps. In the case of “consisting of,” the alternative embodiment excludes any additional compositions, materials, components, elements, features, integers, operations, and / or process steps, while in the case of “consisting essentially of,” any additional compositions, materials, components, elements, features, integers, operations, and / or process steps that materially affect the basic and novel characteristics are excluded from such an embodiment, but any compositions, materials, components, elements, features, integers, operations, and / or process steps that do not materially affect the basic and novel characteristics can be included in the embodiment.

[0019] Any method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order discussed or illustrated, unless specifically identified as an order of performance. It is also to be understood that additional or alternative steps may be employed, unless otherwise indicated.

[0020] The use of the term "a" or "an" when used in conjunction with the term "comprising" in the claims and / or the specification may mean "one," but it is also consistent with the meaning of "one or more," "at least one," and "one or more than one." As such, the terms "a," "an," and "the" include plural referents unless the context clearly indicates otherwise. Thus, for example, reference to "a compound" may refer to one or more compounds, two or more compounds, three or more compounds,four or more compounds, or greater numbers of compounds. The term "plurality" refers to "two or more."

[0021] The use of the term "at least one" will be understood to include one as well as any quantity more than one, including but not limited to, 2, 3, 4, 5, 10, 15, 20, 30, 40, 50, 100, etc. The term "at least one" may extend up to 100 or 1000 or more, depending on the term to which it is attached; in addition, the quantities of 100 / 1000 are not to be considered limiting, as higher limits may also produce satisfactory results. In addition, the use of the term "at least one of X, Y, and Z" will be understood to include X alone, Y alone, and Z alone, as well as any combination of X, Y, and Z. The use of ordinal number terminology (i.e., "first," "second," "third," "fourth," etc.) is solely for the purpose of differentiating between two or more items and is not meant to imply any sequence or order or importance to one item over another or any order of addition, for example.

[0022] The use of the term "or" in the claims is used to mean an inclusive "and / or" unless explicitly indicated to refer to alternatives only or unless the alternatives are mutually exclusive. For example, a condition "A or B" is satisfied by any of the following: A is true (or present) and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present).

[0023] As used herein, any reference to "one embodiment," "an embodiment," "some embodiments," "one example," "for example," or "an example" means that a particular element, feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. The appearance of the phrase "in some embodiments" or "one example" in various places in the specification is not necessarily all referring to the same embodiment, for example. Further, all references to one or more embodiments or examples are to be construed as non-limiting to the claims.

[0024] Throughout this disclosure, the term "about" is used to indicate that a value includes the inherent variation of error for a composition / apparatus / device, the method being employed to determine the value, or the variation that exists among the study subjects. For example, but not by way of limitation, when the term "about" is utilized, the designated value may vary by plus or minus twenty percent, or fifteen percent, or twelve percent, or eleven percent, or ten percent, or nine percent, or eight percent, or seven percent, or six percent, or five percent, or four percent, or three percent, or two percent, or one percent from the specified value, as such variations are appropriate to perform the disclosed methods and as understood by persons having ordinary skill in the ait. Particularly in reference to a given quantity, number or percentage, “about” is meant to encompass deviations of plusor minus ten percent (± 10). For example, about 5% encompasses any value between 4.5% to 5.5%, such as 4.5, 4.6, 4.7, 4.8, 4.9, 5, 4.1, 5.2, 5.3, 5.4, or 5.5. Accordingly, unless otherwise indicated, the numerical parameters set forth in this specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by the presently disclosed subject matter.

[0025] The term "or combinations thereof" as used herein refers to all permutations and combinations of the listed items preceding the term. For example, "A, B, C, or combinations thereof" is intended to include at least one of: A, B, C, AB, AC, BC, or ABC, and if order is important in a particular context, also BA, CA, CB, CBA, BCA, ACB, BAC, or CAB. Continuing with this example, expressly included are combinations that contain repeats of one or more item or term, such as BB, AAA, AAB, BBC, AAABCCCC, CBBAAA, CABABB, and so forth. The skilled artisan will understand that typically there is no limit on the number of items or terms in any combination, unless otherwise apparent from the context.

[0026] As will be understood by one skilled in the art, for any and all purpose, all ranges disclosed herein also encompass any and all possible subranges and combinations of subranges thereof. Furthermore, as will be understood by one skilled in the art, a range includes each individual member.

[0027] Unless defined otherwise, technical and scientific terms used herein have the same meaning as commonly understood by a person of ordinary skill in the art. In particular, this disclosure utilizes routine techniques in the field of gelatin-comprising substances.

[0028] The term “active pharmaceutical ingredient” or “API” as used herein refers to any molecule, composition, formulation, compound, ingredient, or substance that is an active component in a pharmaceutical drug that prevents, diagnosis, treats, or cures disease in a mammal. APIs may be “over-the-counter” and not require a drug prescription, while some may require a drug prescription from a medically-authorized person.

[0029] The term “blister” as used herein may refer to a material (e.g., thermoformed plastic or metal, such as aluminum) comprising an indented portion (i.e., cavity, pocket) that can hold a substance. As used herein, “blister” may refer to a sealed or unsealed blister. For example, a blister may refer to a blister with water and a gelatin-comprising composition in the indented portion that has not been sealed, and a blister may also refer to a blister with a gummy composition in the indented portion that has been sealed. Blisters may be sealed to protect products from external factors such as humidity, contamination, etc. The substance / product inside a sealed blister (e.g. a gummy compositionor product) may be pressed out of the indented portion through the seal, thereby breaking the seal. A blister may be a single blister or part of a blister pack that may include one or more blisters.

[0030] As used herein, a “gummy composition” or “gummy” refers to a chewable, gummy-like product for oral consumption. Although gummies are traditionally used as a candy or sweet product, they are also often used as oral dosage forms for therapeutic agents and supplements. They are usually soft and contain a gelling agent, such as gelatin.C. Method of making a gummy composition

[0031] In one embodiment, a method for making a gummy composition is provided herein. The method may include a heating step, where the heating step includes heating a blister containing water and a gelatin-comprising composition, which undergoes a phase change to eventually yield a gummy composition in the blister. In some embodiments, the heating step includes heating a blister containing water and a gelatin-comprising composition to form a liquid composition in the blister. The water introduced to or present in the blister is external to or independent of any water within the gelatincomprising composition. Additionally, in some embodiments, the method may include a setting step, where the heated gelatin-comprising composition is allowed to set to form a gummy composition in the blister. In other words, the gummy composition is formed in situ in the blister.Gelatin-comprising composition

[0032] In some embodiments, a gelatin-comprising composition may be a solid oral dosage form. For example, a solid oral dosage may be a tablet, powder, pill, or granule. In a particular embodiment, a solid oral dosage form may be a powder. In another embodiment, the solid oral dosage form may be a tablet (e.g., a compressed tablet). In some embodiments, the compressed tablet may have a hairiness 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 tablet may have a hardness of about 3.15 to, and including, about 3.85. In a particular embodiment, the compressed tablet may have a hairiness of about 3.5 kP. In some embodiments, the tablets are less hard than standard tablets, thus they do not take as long to absorb the external water and form gummies.

[0033] In some embodiments, the gelatin-comprising composition, such as a compressed tablet or powder, is capable of or configured to dissolve in water. In some embodiments, the gelatin-comprising composition may be generated via known methods such as dry granulation, direct compression, etc. In some embodiments, the gelatin-comprising composition is dry. In some embodiments, a powdercomprising gelatin may be compressed using conventional tableting equipment, such as a Flexitab® tablet press. The gelatin-comprising powder may be compressed into tablets of various size and weight ranges. For example, in some embodiments, the gelatin-comprising composition (e.g., tablet or powder) may be about 50 mg, about 100 mg, about 150 mg, about 200 mg, about 250 mg, about 300 mg, about 350 mg, about 400 mg, about 450 mg, about 500 mg, about 550 mg, about 600 mg, about 650 mg, about 700 mg, about 750 mg, about 800 mg, about 850 mg, about 900 mg, about 950 mg, about lOOOmg, about 1100 mg, about 1200 mg, about 1300 mg, about 1400 mg, about 1500 mg, about 1600 mg, about 1700 mg, about 1800 mg, about 1900 mg, about 2000 mg, about 2100 mg, about 2200 mg, about 2300 mg, about 2400 mg, about 2500 mg, about 2600 mg, about 2700 mg, about 2800 mg, about 2900 mg, or about 3000 mg. In some embodiments, the gelatin-comprising composition may be at least about 200 mg. In a specific embodiment, the gelatin-comprising composition may be about 250 mg. In another embodiment, the gelatin-comprising composition may be about 1000 mg. In some embodiments, the gelatin-comprising tablet may be in any general shape (e.g., sphere, cube, cylinder, etc.). In some embodiments, the gelatin-comprising composition may dissolve in water.Gelatin

[0034] A gelatin-comprising composition may include, for example, about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, about 15%, about 16%, about 17%, about 18%, about 19% about 20%, about 21%, about 22%, about 23%, about 24%, or about 25% gelatin. In some embodiments, the gelatin-comprising composition includes about 8% gelatin. In some embodiments, a gelatincomprising composition may include, for example, about 1% to about 20%, about 2% to about 20%, about 3% to about 20%, about 4% to about 20%, about 5% to about 20%, about 6% to about 20%, about 7% to about 20%, about 8% to about 20%, about 9% to about 20%, about 10% to about 20%, about 11% to about 20%, about 12% to about 20%, about 13% to about 20%, about 14% to about 20%, about 15% to about 20%, about 16% to about 20%, about 17% to about 20%, about 18% to about 20%, about 19% to about 20%, about 1% to about 19%, about 1% to about 18%, about 1% to about 17%, about 1% to about 16%, about 1% to about 15%, about 1% to about 14%, about 1% to about 13%, about 1% to about 12%, about 1% to about 11%, about 1% to about 10%, about 1% to about 9%, about 1% to about 8%, about 1% to about 7% about 1% to about 6%, about 1% to about 5%, about 1% to about 4%, about 1% to about 3%, about 1% to about 2%, about 2% to about 15%, about 3% to about 15%, about 4% to about 15%, about 5% to about 15%, about 6% to about 15%, about 7% to about 15%, about 8% to about 15%, about 9% to about 15%, about 10% to about 15%, about 11% to about15%, about 12% to about 15%, about 13% to about 15%, about 14% to about 15%, about 5% to about 14%, about 5% to about 13%, about 5% to about 12%, about 5% to about 11%, about 5% to about 10%, about 5% to about 9%, about 5% to about 8%, about 5% to about 7%, or about 5% to about 6% gelatin. In some embodiments, the gelatin-comprising composition includes about 5% to about 15% gelatin. In some embodiments, gelatin may be added as a gelling agent (e.g., a thickener, stabilizer, texturizer, or a combination thereof). In some embodiments, the gelatin may help thicken, stabilize, or add texture to the gummy composition. In some embodiments, the gelatin may have low, medium, or high bloom strength. Gelatin bloom number may indicate the firmness or softness of a specific type of gelatin. Low bloom gelatin may fall within the range of 50-125. Medium bloom gelatin may fall within the range of 175-225. High bloom gelatin may fall within the range of 225-325. Additionally, in some embodiments, the gelatin bloom may be categorized as type A or type B. Type A gelatin may be created by treating collagen with acid, and may be derived from, for example, pig skin, fish skin / scales, beef hides or beef bones. Type A gelatin may have a lower viscosity, but higher bloom than type B. Type B gelatin may be manufactured using a high-pH treatment, and may be derived from pig skin, fish skin / scales, beef hides or beef bones. Type B gelatin may have a higher viscosity, but lower bloom strength than type A. In a particular embodiment, the gelatin may be Bloom 250 pork skin gelatin type A (40 mesh). In some embodiments, the gelatin in the composition may include a vegan substitute, such as agar, carrageenan, modified starch, alginate, or pectin. Thus, “gelatin” as referred to herein may be referring to a gelatin-like substance (e.g., a vegan substitute).Active Pharmaceutical Ingredient (API)

[0035] In some embodiments, the gelatin-comprising composition may include an active pharmaceutical ingredient (API). In other embodiments, the gelatin-comprising composition may not include an API (e.g., a placebo).

[0036] The API, when present, is a water- stable API or in a form that is water stable, meaning that the API is stable (does not degrade) in the presence of external water present in the blister during manufacturing of the gummy product in situ.

[0037] In some embodiments, the API can be from a therapeutic class of drugs, such as antihistamines, decongestants, antacids, antidiarrheals, analgesics, antibiotics, antivirals, sedatives and stimulants; or a combination of therapeutic classes of drugs

[0038] Non-limiting examples of APIs include inorganic molecules such as acids, oxo acids, hydroxides, metal oxides, non-metal oxides, binary salts and those containing polyatomic ions,peroxides, aragonite, potassium, phosphorous, calcium, magnesium, sulfur, sodium chloride, calcium chloride, potassium chloride, sodium sulfate, calcium phosphate, calcium carbonate, zinc sulfate, and magnesium chloride, organic molecule such as nucleic acids, lipids, sugars, proteins, enzymes, hydrocarbon fuels, carbohydrates, solvents, drugs, vitamins, dyes, artificial flavors, toxins, molecules used as precursors to biochemical compounds, cetirizine (commonly referred to as Zyrtec®), fexofenadine (commonly referred to as Allegra ®), loratadine (commonly referred to as Claritin®), desloratadine (commonly referred to as Clarinex®, etc.), azelastine (commonly referred to as Astelin®, Astepro®, Optivar®, etc.), dextromethorphan hydrobromide (commonly referred to as Dex. HBr, Benylin®, Delsym®, etc.), naproxen sodium (commonly referred to as Aleve®, Anaprox®, Naprosyn®, etc.), diphenhydramine hydrochloride (commonly referred to as Benadryl®, Banophen™, etc.), acetaminophen (commonly refer ed to as Tylenol®, etc.), guaifenesin (commonly referred to as Guiatuss®, Robitussin®, etc.), chlorpheniramine (commonly referred to as Chlor- Trimeton®, Piriton™, etc.), phenylephrine (commonly referred to as Neo-synephrine®, etc.), pseudoephedrine (commonly referred to as Afrinol, Sudafed®, etc.), doxylamine (commonly referred to as Unisom®, Vicks®, etc.), mometasone (commonly referred to as Elocon®, etc.), caffeine, acetaldehyde, acetone, biotin, heptane, vanillin, methanol, bromophenol blue, carbon tetrachloride, fullerene, and benzaldehyde. The organic molecule may be natural or synthetic. In a particular embodiment, the API may be loratadine. In another embodiment, the API may be acetaminophen. In some embodiments, the API may include a vitamin premix.

[0039] Each API may be present in the gelatin-comprising composition in an amount of about 0.01 wt. %, about 0.02 wt. %, about 0.03 wt. %, about 0.04 wt. %, about 0.05 wt. %, about 0.06 wt. %, about 0.07 wt. %, about 0.08 wt. %, about 0.09 wt. %, about 0.1 wt. %, about 0.5 wt. %, about 1 wt. %, about 1.5 wt. %, about 2 wt. %, about 2.5 wt. %, about 3 wt. %, about 3.5 wt. %, about 4 wt. %, about 4.5 wt. %, about 5 wt. %, about 5.5 wt.%, about 6 wt. %, about 6.5 wt.%, about 7 wt.%, about 7.5 wt. %, about 8 wt. %, about 8.5 wt.%, about 9 wt.%, about 9.5 wt.%, or about 10 wt.% based on the total weight of the composition. Each API may be present in the gelatin-comprising composition in an amount of about 0.1 wt.% to about 5 wt.%, about 0.2 wt.% to about 4.5 wt.%, about 0.3 wt.% to about 4 wt.%, about 0.4 wt.% to about 3.5 wt.%, about 0.5 wt.% to about 3 wt.%, about 0.6 wt.% to about 2.5 wt.%, about 0.7 wt.% to about 2 wt.%, about 0.8 wt.% to about 1.5 wt.%, about 0.9 wt.% to about 1 wt.%, about 0.01 wt.% to about 10 wt.%, about 0.02 wt.% to about 10 wt.%, about 0.03 wt.% to about 10 wt.%, about 0.04 wt.% to about 10 wt.%, about 0.05 wt.% to about 10 wt.%, about 0.06 wt.% to about 10 wt.%, about 0.07 wt.% to about 10 wt.%, about 0.08 wt.% to about 10 wt.%, about0.09 wt.% to about 10 wt.%, about 0.1 wt.% to about 10 wt.%, about 0.5 wt.% to about 10 wt.%, about 1 wt.% to about 10 wt.%, about 1.5 wt.% to about 10 wt.%, about 2 wt.% to about 10 wt.%, about 2.5 wt.% to about 10 wt.%, about 3 wt.% to about 10 wt.%, about 3.5 wt.% to about 10 wt.%, about 4 wt.% to about 10 wt.%, about 4.5 wt.% to about 10 wt.%, about 5 wt.% to about 10 wt.%, about 5.5 wt.% to about 10 wt.%, about 6 wt.% to about 10 wt.%, about 6.5 wt.% to about 10 wt.%, about 7 wt.% to about 10 wt.%, about 7.5 wt.% to about 10 wt.%, about 8 wt.% to about 10 wt.%, about 8.5 wt.% to about 10 wt.%, about 9 wt.% to about 10 wt.%, about 9.5 wt.% to about 10 wt.%, about 0.01 wt.% to about 9.5 wt.%, about 0.01 wt.% to about 9 wt.%, about 0.01 wt.% to about 8.5 wt.%, about 0.01 wt.% to about 8 wt.%, about 0.01 wt.% to about 7.5 wt.%, about 0.01 wt.% to about 7 wt.%, about 0.01 wt.% to about 6.5 wt.%, about 0.01 wt.% to about 6 wt.%, about 0.01 wt.% to about 5.5 wt.%, about 0.01 wt.% to about 5 wt.%, about 0.01 wt.% to about 4.5 wt.%, about 0.01 wt.% to about 4 wt.%, about 0.01 wt.% to about 3.5 wt.%, about 0.01 wt.% to about 3 wt.%, about 0.01 wt.% to about 2.5 wt.%, about 0.01 wt.% to about 2 wt.%, about 0.01 wt.% to about 1.5 wt.%, about 0.01 wt.% to about 1 wt.%, about 0.01 wt.% to about 0.9 wt.%, about 0.01 wt.% to about 0.8 wt.%, about 0.01 wt.% to about 0.7 wt.%, about 0.01 wt.% to about 0.6 wt.%, about 0.01 wt.% to about 0.5 wt.%, about 0.01 wt.% to about 0.4 wt.%, about 0.01 wt.% to about 0.3 wt.%, or about 0.01 wt.% to about 0.2 wt.% based on the total weight of the composition. In a particular embodiment, the API may be present in the gelatin-comprising compound in an amount of 0.1-5 wt. % based on the total weight of the composition. In some embodiments, the API may impart a bitter taste perception. In some embodiments, a taste-masking agent, such as an effervescent composition comprising sodium bicarbonate and citric acid, flavorings, sweeteners, oils, etc., may be included in the gelatin-comprising composition. In some embodiments, APIs, such as acetaminophen, may be taste masked by including beta cyclodextrin in the composition.Additional optional components of the gelatin-comprising composition

[0040] The gelatin-comprising composition described herein can be prepared by known methods. For example, the gelatin-comprising composition may be mixed with one or more pharmaceutically acceptable excipient / additive. Suitable additives are all customary formulation auxiliaries. Nonlimiting examples of pharmaceutically acceptable excipients include sweeteners, flavoring agents, lubricants, extenders, solvents or diluents, solid earners and fillers, surfactants, dispersants or binders or fixatives, preservatives, dyes and pigments, defoamers, inorganic and organic thickeners, water repellants, and other further processing auxiliaries. In certain embodiments, flavors and / or sweeteners may be added to the gelatin-comprising composition to make the gummy composition more palatableto a consumer. In an example embodiment, citric acid anhydrous may be included in the composition as a preservative. In another example embodiment, FD & C Yellow No. 6 dye may be included in the gelatin-comprising composition. Additionally, water may be added to a gelatin-comprising composition, for example, to form a gummy composition. In some embodiments, water may be included as a solvent and / or hydrating agent. Water may be in the form of liquid, solid, or gas (i.e., water vapor or steam).

[0041] A non-limiting list of flavoring agents includes natural flavoring agents (such as those derived from natural sources like plants, fruits, and vegetables), artificial flavoring agents (such as vanillin synthetically produced for a vanilla flavor), processed flavoring agents (such as smoked flavors, roasted flavors, and fermented flavors), masking agents (such as salt, cyclodextrin, etc.) and sweeteners. Examples of natural flavoring agents are vanilla extract, cinnamon, ginger, and citrus oils. In a particular embodiment, the flavoring agent may be Evospray® orange flavor. A flavoring agent may be present in a gelatin-comprising composition in an amount of about 0.1-10 wt. % or about 1-3 wt. %. In some embodiments, a gelatin-comprising composition may include at least about 1 wt. %, about 2 wt. %, about 3 wt. %, about 4 wt. %, about 5 wt. %, about 6 wt. %, about 7 wt. %, about 8 wt. %, or about 9 wt. % flavoring agents.

[0042] A non-limiting list of sweeteners includes sugar (such as sucrose, fructose, and glucose), sugar alcohol (such as erythritol and maltitol), sugar substitute (such as aspartame, sucralose, and stevia), syrups, honey, molasses, glycyrrhizin, unrefined sweetener (such as coconut sugar), and allulose). In a particular embodiment, the sweetener is compressible sugar. In some embodiments, the sweetener may be present in the gelatin-comprising composition in an amount of at least about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, or about 95%. Bulking agents such as corn syrup solids and food starch may also be included in the gelatin-comprising composition.

[0043] A non-limiting list of lubricants includes solid lubricants (such as calcium stearate, magnesium stearate, talc, etc.) and liquid lubricants (such as liquid paraffin). Additional examples of lubricants include stearic acid, sodium stearyl fumarate, polyethylene glycols, and silicon dioxide. In a particular embodiment, the gelatin-comprising composition may include magnesium stearate. In some embodiments, the lubricant used in the gelatin-comprising composition, such as magnesium stearate, may be used to avoid sticking of the gelatin-comprising composition to tableting machine parts.

[0044] In some embodiments, colorants such as inorganic pigments can be included in the gelatincomprising composition. Examples of inorganic pigments include iron oxide, titanium oxide, Prussian blue, and organic dyes, such as alizarin dyes, azo dyes, and metal phthalocyanine dyes, and trace nutrients, such as salts of iron, manganese, boron, copper, cobalt, molybdenum, and zinc. A colorant may be present in a gelatin-comprising composition in an amount of about 0.001-5 wt. % or about 0.001-0.1 wt. %. In some embodiments, a gelatin-comprising composition may include at least about 0.001 wt. %, about 0.01 wt. %, about 0.1 wt. %, about 1 wt. %, about 2 wt. %, about 3 wt. %, or about 4 wt. % colorants.

[0045] Other additives may also be present. For example, such additional components may include protective colloids, binders, adhesives, thickeners, thixotropic substances, penetrants, stabilizers, sequestering agents, and complex formers. For example, the gelatin-comprising composition may include the binder, povidone. In general, the active compounds can be combined with any solid or liquid additive customarily used for formulation purposes. Additional gelling agents may be included in the composition in addition to gelatin. For example, cellulose, pectin, xanthan gum, pre-gelatinized starch, hydroxypropyl cellulose, fruit pectin powder, hydroxyethyl cellulose, or a combination thereof, may be included to thicken, stabilize, or add texture to the gummy composition. In a specific embodiment, the gelatin-comprising composition includes gelatin and cellulose. In some embodiments, a gelatin-comprising composition additive may be present in the gelatin-comprising composition in an amount of about 10 wt. % to about 20 wt. %, about 20 wt. % to about 30 wt. %, about 30 wt. % to about 40 wt. %, about 40 wt. % to about 50 wt. %, about 50 wt. % to about 60 wt. %, 60 wt. % to about 70 wt. %, 70 wt. % to about 80 wt. %, 80 wt. % to about 90 wt. %, 90 wt. % to about 99 wt. %, about 1 wt. % to about 50 wt. %, about 5 wt. % to about 45 wt. %, about 10 wt. % to about 40 wt. %, and about 20 wt. % to about 40 wt. %, about 50 wt. % to about 99 wt. %, about 60 wt. % to about 90 wt. %, or about 70 wt. % to about 80 wt. %, based on the total weight of the composition.

[0046] In some embodiments, the gelatin-comprising composition may include one or more superdisintegrants. In some embodiments, the superdisintegrant(s) may enhance the hydration process since they readily absorb water. In some embodiments, a gelatin-comprising composition may comprise about 1-15 wt. % or about 3-5 wt. % of one or more superdisintegrants. In some embodiments, a composition may include less than or equal to about 15 wt. %, about 12 wt. %, about 10 wt. %, about 8 wt. %, about 5 wt. %, about 4 wt. %, about 3 wt. %, or about 2 wt. % of one or more superdisintegrants. In some embodiments, a gelatin-comprising composition may include at least about 1 wt. %, about 2 wt. %, about 3 wt. %, about 4 wt. %, about 5 wt. %, about 8 wt. %, about 10wt. %, or about 12 wt. % of one or more superdisintegrants. Suitable superdisintegrants may include, but are not limited to croscarmellose sodium, sodium starch glycolate, and starch (e.g., partially pregelatinized com starch). In some embodiments, the gelatin-comprising composition may include both croscarmellose sodium and sodium starch glycolate. In some embodiments, the gelatin-comprising composition may include equal amounts of croscarmellose sodium and sodium starch glycolate. In some embodiments, one or more superdisintegrants may include only starch. In some embodiments, including two superdisintegrants may provide a synergistic effect (more than additive) of disintegration in some gelatin-containing compositions.

[0047] In a particular embodiment, the gelatin-comprising composition may include 60-95 wt. % one or more sweetener, 5-15 wt. % gelatin, and 0.1-5 wt. % one or more API. In a specific embodiment, the gelatin-comprising composition may include 89.49 wt. % sweetener. In a specific embodiment, the gelatin-comprising composition may include 8 wt. % gelatin. In a certain embodiment, the gelatincomprising composition may include 4 wt. % API. In a certain embodiment, the API may be loratadine. In a certain embodiment, the sweetener may be compressible sugar'. In a certain embodiment, the gelatin may be Bloom 250 pork skin gelatin type A (40 mesh). In some embodiments, the gelatin-comprising composition may also include citric acid anhydrous, Evospray® orange flavor, and FD & C Yellow No. 6 dye. In some embodiments, the gelatin-comprising composition may include a lubricant, preservative, superdisintegrant, or a combination thereof. In some embodiments, the gelatin-comprising composition may be about a 250 mg dry tablet.Heating Step

[0048] As discussed above, the method of making a gummy composition may include a heating step comprising heating a blister containing a gelatin-comprising composition, described herein, and water in the blister.

[0049] In some embodiments, the blister may be formed from plastic (e.g. thermoformed plastic) or metal, such as aluminum. In some embodiments, the blister may be formed before the gelatincomprising composition (e.g., tablet or powder) and water are added to the blister (i.e., the blister may be preformed). In some embodiments, the blister may be a single blister. In other embodiments, the blister may be part of a blister pack. For example, the blister pack may include one or more blisters. For example, a blister pack may include 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, or more separate blisters. In a particular embodiment, the blister pack may include 6 blisters. In another embodiment, the blister pack may include 10 blisters.In some embodiments, gelatin-comprising compositions and water may be added to one or more blisters in the blister pack. In some embodiments, each of the one or more blisters in a blister pack may undergo the heating step substantially at the same time or about the same time or simultaneously.[00501 For example, a blister including a gelatin-comprising composition described herein, such as a compressed tablet, and water may be heated in or inside the blister (in other words in the indented portion of the blister).

[0051] In some embodiments, the blister containing water and a gelatin-comprising composition may be exposed to heat (e.g., in an oven). In some embodiments, the blister may be exposed to heat after the gelatin-comprising composition and water has been added to a blister and the blister has been sealed (e.g., with heat or adhesive). Additionally or alternatively, the blister may be exposed to heat after the gelatin-comprising composition and water has been added to a blister, and the open blister has been covered by a sealing material but not sealed. The blister comprising water and a gelatincomprising composition may be exposed to heat of at least about 30°C, about 35°C, about 40°C, about 45°C, about 50°C, about 55°C, about 60°C, about 65°C, about 70°C, about 75°C. In some embodiments, the blister may be exposed to heat at least at about 45°C to about 60°C. In a particular embodiment, the blister may be exposed to heat at about 60°C. In some embodiments, the blister may be exposed to heat for at least about 0.1, about 0.2, about 0.3, about 0.4, about 0.5, about 0.6, about 0.7, about 0.8, about 0.9, about 1, about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11, about 12, about 13, about 14, about 15, about 16, about 17, about 18, about 19, about 20, about 21, about 22, about 23, about 24 hours or more. In a particular embodiment, the blister may be exposed to heat for about 30 min to about 2 hours, particularly about 1 hour. In some embodiments, the blister may be exposed to heat for at least about 12 hours. In a particular embodiment, the blister may be exposed to heat for about 24 hours. In one embodiment, the blister comprising water and a gelatin-comprising composition may be exposed to about 45 °C to about 60°C temperature for about 1 hour.

[0052] In some embodiments, after the blister is heated, the blister may be removed from the heat. During or following the heating step, the gelatin-comprising composition in the blister undergoes a phase change. In some embodiments, the gelatin-comprising composition may dissolve into liquid form. Thus, the blister may comprise a liquid gelatin-comprising composition.Setting Step

[0053] In some embodiments, the method of making a gummy composition further comprises allowing the heated gelatin-comprising composition in the blister to set. In some embodiments, the heated gelatin-comprising composition may become liquid or molten in the blister. In some embodiments, allowing the heated gelatin-comprising composition to set may include allowing the composition to become more solid. In other words, the heated gelatin-comprising composition in the blister may be allowed to congeal (i.e., to solidify or coagulate by cooling). In some embodiments, the heated gelatin-comprising composition in the blister may be allowed to set before or after the blister is sealed. In a particular embodiment, the heated gelatin-comprising composition in the blister may be allowed to set after the blister is sealed. In some embodiments, the heated gelatin-comprising composition in or inside the blister may be allowed to set for about 0.25 hours, about 0.5 hours, about 1 hour, about 1.5 hours, about 2 hours, about 2.5 hours, about 3 hours, about 3.5 hours, about 4 hours, about 4.5 hours, about 5 hours, about 5.5 hours, about 6 hours, about 6.5 hours, about 7 hours, about 7.5 hours, about 8 hours, about 8.5 hours, about 9 hours, about 9.5 hours, or about 10 hours. In some embodiments, the heated gelatin-comprising composition may be allowed to set for at least about 3 hours. In some embodiments, the heated gelatin-comprising composition may be allowed to set at about -25°C, about -20°C, about -15°C, about -10°C, about -5°C, about 0°C, about 5°C, about 10°C, about 15 °C, about 20°C, or about 25 °C. In a specific embodiment, the heated gelatin-comprising composition in the blister may be allowed to set for about 6 hours at an ambient temperature of about 20-22°C (i.e., about room temperature). Alternatively, in some embodiments, lower temperatures may allow the gelatin-comprising composition to set faster. In some embodiments, the heated gelatincomprising composition in the blister may be allowed to set for about 20 to about 40 minutes at an ambient temperature of about 2°C to about 8 °C. In another example, it may take 6 hours for the composition to set at room temperature, while it may take 3 hours for the composition to set at an ambient temperature of 10°C. One skilled in the art is aware of how to adjust temperature and time to allow the heated gelatin-composition to form or set into a gummy composition. Once the gelatincomprising composition has been set, it may be referred to as a gummy composition. Thus, a gummy composition prepared by the disclosed methods is provided herein. The present disclosure also provides a blister (or blister pack) comprising the gummy composition described herein. In some embodiments, the blister may be part of a blister pack that includes one or more blisters.Additional Steps

[0054] In some embodiments, the method further comprises compressing the gelatin-comprising composition into, for example, a tablet. Conventional tableting equipment, such as a Flexitab® tabletpress, is known in the art and the gelatin-compressing composition may be compressed into tablets of various size / weight ranges (i.e., 250mg, lOOOmg, 1500mg, etc.).

[0055] In some embodiments, the method further comprises placing the gelatin-comprising composition into a blister. In some embodiments, a gelatin-comprising composition may be placed in a preformed blister. In some embodiments, one or more gelatin-comprising composition (e.g., one or more tablet) may be added to the blister. In some embodiments, one gelatin-comprising tablet may be added per blister.

[0056] In some embodiments, the method further comprises coating at least a portion of the inside of the blister (or the internal indented portion) with a lubricant, such as Capol® 3073. The lubricant may include one or more waxy material such as a highly stable vegetable oil and / or a natural wax. The lubricant may help keep the formed gummies from sticking to the inside of the blister. Additionally or alternatively, the lubricant may keep the gummies soft by retaining moisture in them.

[0057] In some embodiments, the method further comprises adding water to a blister. In some embodiments, water is added to or present in a preformed blister. In some embodiments, water is added to or present in the blister to hydrate the gelatin-comprising composition. In some embodiments, water may be added to or present in the blister before the gelatin-comprising composition is added to or present in the blister. Additionally or alternatively, water may be added to or present in the blister after the gelatin-comprising composition is added to or present in the blister. In some embodiments, water and the gelatin-comprising composition may be added to or present in the blister concurrently. In some embodiments, the water may be purified water. Additionally or alternatively, in some embodiments, the water may be deionized water. Additionally or alternatively, in some embodiments, the water may be distilled water. In some embodiments, the water is a liquid. In some embodiments, the water is a gas (i.e., steam). In some embodiments, the water is a solid (i.e., ice). In a specific embodiment, the water is a purified liquid. In some embodiments, a predetermined amount of water may be added to the blister.

[0058] In some embodiments, water is added to or present in the blister in an amount of about 50 wt. %, about 55 wt. %, about 60 wt. %, about 75 wt. %, about 80 wt. %, about 85 wt. %, about 90 wt. %, or about 95 wt. % of the gelatin-comprising composition (e.g., tablet or powder). In a specific embodiment, water is added to or present in the blister in an amount of about 75 wt. % of the gelatincomprising composition. In an example embodiment, 200 mg of water may be added to or present in a blister having a 250 mg tablet in the blister. In this example embodiment, the total gummycomposition weight (after setting) may become about 450 mg.

[0059] In some embodiments, the method may further comprise a sealing step to seal the blister with a cover. In some embodiments, the blister may be sealed before or after the blister is heated to generate a liquid composition. In a specific embodiment, the blister may be sealed before the heating step. In another specific embodiment, the blister may be covered by a sealing material, the blister is heated, and afterwards the blister is sealed. In some embodiments, the sealing step may include closing the blister by heat sealing a material over the opening of the blister. In some embodiments, the sealing step may include closing the blister by compressing a sealing material to a blister to seal the blister, wherein at least a portion of the sealing material, at least a portion of the blister, or both, have an adhesive. In some embodiments, the sealing material may be plastic, aluminum, cardboard or a combination thereof. In some embodiments, a heat source may heat a portion of the sealing material and / or a portion of the blister to seal the blister. In some embodiments, the heat source may allow the sealing material to stick to the blister. In some embodiments, an aluminum sealing material is sealed on a portion of a pre -formed plastic or aluminum blister. In some embodiments, the gelatin-comprising composition is not contacted by the heat source.

[0060] In some embodiments, the blister may be sealed using suitable equipment such as the Sepha® EZB11. In some embodiments, the blister may be sealed at about 90°C, about 95°C, about 100°C, about 105°C, about 110°C, about 115°C, about 120°C, about 125°C, about 130°C, about 135°C, about 140°C, about 145°C, about 150°C, about 155°C, about 160°C, about 165°C, about 170°C, about 175°C, about 180°C, about 185°C, or about 190°C. In a particular embodiment, the blister may be sealed at about 140°C. In some embodiments, the heat source may heat a portion of the sealing material and / or blister for about 0.25 minutes, about 0.5 minutes, about 0.75 minutes, about 1 minute, about 1.25 minutes, about 1.5 minutes, about 1.75 minutes, about 2 minutes, about 2.25 minutes, about 2.5 minutes, about 2.75 minutes, about 3 minutes, about 3.25 minutes, about 3.5 minutes, about 3.75 minutes, about 4 minutes, about 4.25 minutes, about 4.5 minutes, about 4.75 minutes, or about 5 minutes. In a specific embodiment, the blister may be sealed for about 3 minutes. In some embodiments, the blister may be checked to confirm it has been sealed (e.g., the sealed blister may be checked for one or more leaks). In some embodiments, the blister may be visually checked for leaks.

[0061] In some embodiments, the gummy composition may melt or dissolve / disintegrate by contact with saliva and / or mild chewing in the mouth. In some embodiments, the gummy composition may be soft in feel. In some embodiments, the gummy composition may have a tender feel when chewed. In some embodiments, the gummy composition may be clear or substantially clear. In someembodiments, the gummy may include a dye, such as FD & C Yellow No. 6 dye, and may be the color of the dye (e.g., yellow).

[0062] In some embodiments, adding water and / or a gelatin-comprising composition to a blister, sealing the blister, and / or allowing the gelatin-comprising composition in the blister to set may be automated. For example, the blister may be sealed in a production line. In some embodiments, the sealed blisters could pass through a heating tunnel for a few minutes, followed by a cooling tunnel for a few minutes. The automated processed could result in a gummy composition as described herein, such as a clear gummy composition.Use / Method of Treatment

[0063] In a further embodiment, a method is provided herein for treating one or more health conditions comprising administering a gelatin-comprising composition or gummy composition described herein to a subject or patient. A non-limiting list of health conditions includes allergies, cough, cold, pain, cardiovascular disorders, nutritional deficiencies, digestive disorders, cancer, bacterial infections, fungal infections, viral infections, diabetes, food poisoning, headaches, kidney disease, etc.

[0064] In some embodiments, treatment includes an approach for obtaining beneficial or desired results, including clinical results. Beneficial or desired clinical results may include one or more of the following: a) inhibiting the disease or condition, (e.g., decreasing one or more symptoms resulting from the disease or condition, and / or diminishing the extent of the disease or condition); b) slowing or arresting the development of one or more clinical symptoms associated with the disease or condition (e.g., stabilizing the disease or condition, preventing or delaying the worsening or progression of the disease or condition, and / or preventing or delaying the spread (e.g., metastasis) of the disease or condition); and / or c) relieving the disease, that is, causing the regression of clinical symptoms (e.g., ameliorating the disease state, providing partial or total remission of the disease or condition, enhancing effect of another medication, delaying the progression of the disease, increasing the quality of life, and / or prolonging survival).

[0065] In some embodiments, prevention includes treatment of a disease or condition that causes the clinical symptoms of the disease or condition not to develop or progress. Gelatin-comprising compositions or gummy compositions may, in some embodiments, be administered to a subject (including a human) who is at risk or has a family history of the disease or condition in order to preventthe disease or condition.

[0066] In some embodiments, methods are provided herein for treating and / or preventing allergies (e.g., hay fever, hives, conjunctivitis, and reactions to insect bites or stings). In some embodiments, the method comprises administering to a patient a gelatin-comprising composition or gummy composition comprising an API, such as loratadine, acetaminophen, or a pharmaceutically acceptable salt thereof. In some embodiments, the method comprises administering to a patient a gelatincomprising composition or gummy composition comprising nutritional ingredients such as calcium carbonate, and vitamins such as ascorbic acid (vitamin C), tocopherols (vitamin E), and retinols (vitamin A).EXAMPLES

[0067] The following examples are merely illustrative, and do not limit this disclosure in any way.

[0068] EXAMPLE 1: Formulations

[0069] Formulations comprising gelatin can be prepared according to Tables 1-3 below. The following tables illustrate the preparation of gelatin-comprising dry tablets to generate gelatincomprising gummy compositions in situ in a blister.

[0070] Table 1: Formulation 1 - Placebo with no active ingredient

[0071] Formulation 1 may be in the form of a tablet and may be used to form a gummy composition. Magnesium stearate is used as an external lubricant during tablet compression. Note this formulation does not contain an API.

[0072] Table 2: Formulation 2 - Blister gummy with loratadine, lOmg per gummy (450 mg gummy weight)

[0073] Formulation 2 may be in the form of a tablet and may be used to form a gummy composition. Magnesium stearate is used as an external lubricant during tablet compression. Note the API in this formulation is loratadine. Once the 250 mg dry tablet was manufactured, about 200 mg of purified water was added to it. The total gummy weight became about 450 mg or 0.45 g.

[0074] Table 3: Formulation 3 - Blister gummy with loratadine, lOmg per gummy (1750 mg gummy weight)

[0075] Formulation 3 may be in the form of a tablet and may be used to form a gummy composition. Magnesium stearate is used as an external lubricant during tablet compression. Note the API in this formulation is loratadine. Once the 1000 mg dry tablet was manufactured, about 750 mg of purified water was added to it. The total gummy weight became about 1750 mg or 1.75 g.

[0076] EXAMPLE 2: Production of gummy composition in plastic blister

[0077] Exemplary formulations according to the disclosure were made according to the following general procedure. In general, after dry tablets were formed / compressed, they were placed in a preformed blister with purified water, and gummies were formed from the tablet and water in the sealed blister itself (FIG. 1).

[0078] A powder blend containing core gummy ingredients (e.g., Formulations 1-3) was compressed using conventional tableting equipment, such as a Flexitab® tablet press, into tablets of various size / weight ranges (i.e., 250mg, lOOOmg, 1500mg, etc.) by using magnesium stearate as anexternal lubricant to avoid sticking of the gelatin base blend to the tableting machine parts. The hardness of the tablets was about 3.5 kP, which is less than standard tablets, as hard tablets take longer to absorb water and form gummies.[00791 The tablets were then placed into preformed plastic blisters which were coated with lubricant, Capol® 3073, which is a mixture of waxy materials like highly stable vegetable oils and natural waxes. This lubricant prevents the formed gummies from sticking to the blister walls as well as keeps the gummies soft by retaining moisture in them.

[0080] Once the tablets were placed in the preformed blister (one tablet per blister), a predetermined amount of purified water was added (about 75 wt. % of tablet weight for best results), and the blister was sealed at about 140°C for the aluminum foil to stick to the plastic blister using Sepha® EZB 11 machine for a few minutes (about 3 minutes) to ensure the blisters were sealed appropriately. The blisters were visually checked for any leaks and then placed in an oven at about 60°C for 1 hour. After 1 hour, the blisters were taken out of the oven. The hydrated tablets were fluid at this stage and were allowed to set for about 6 hours at room temperature (this can be expedited by allowing them to set / congeal at lower temperatures). The result is a gummy composition which is soft in feel.

[0081] On a commercial scale, the addition of water to the blister may be automated and the blister can be sealed in line. The sealed blisters can then pass through a heating tunnel followed by a cooling tunnel resulting in clear, soft gummies.

Claims

CLAIMSWHAT IS CLAIMED IS:

1. A method of making a gummy composition, the method comprising: a heating step comprising heating a blister containing a gelatin-comprising composition and water independent of the gelatin-comprising composition in the blister; and allowing the heated gelatin-comprising composition in the blister to set to form the gummy composition in the blister.

2. The method of claim 1, wherein the heated gelatin-comprising composition forms a liquid composition during the heating step, and the liquid composition is allowed to set to form the gummy composition in the blister.

3. The method of claim 1 or 2, further comprising placing the gelatin-comprising composition into the blister.

4. The method according to any one of claims 1 to 2, further comprising adding the water, preferably purified water, to the blister.

5. The method of any one of the previous claims, wherein an amount of water present in the blister is about 75% of the gelatin-comprising composition weight.

6. The method of any one of the previous claims, further comprising coating the inside of the blister with a lubricant.

7. The method of any one of the previous claims, further comprising a sealing step to seal the blister with a cover.

8. The method of claim 7, wherein the sealing step is carried out by heating at least a portion of the cover to at least a portion of the blister at about 90°C to about 190°C.

9. The method of any one of the previous claims, wherein the heating step comprises heating the blister containing the gelatin-comprising composition and water at an ambient temperature of about 45 °C to about 60°C for about one hour to about 3 hours.

10. The method of any one of the previous claims, wherein the heated gelatin-comprising composition is allowed to set at an ambient temperature of about 20-22°C for about one hour to about ten hours.11 . The method of any one of the previous claims, wherein the heated gelatin-comprising composition is allowed to set at an ambient temperature of about 2° C to about 8° C for about 20 minutes to about 40 minutes.

12. The method of any one of the previous claims, further comprising compressing the gelatincomprising composition.

13. The method of any one of the previous claims, wherein the gelatin-comprising composition is a solid oral dosage form, such as a compressed tablet or a powder.

14. The method of claim 12, wherein the compressed tablet has a hardness of about 3.15 kP to about 3.85 kP, preferably about 3.5 kP.

15. The method of any one of the previous claims, wherein the gelatin-comprising composition comprises about 5% to about 8% gelatin, one or more sweetener, one or more preservative, and one more active pharmaceutical ingredient (API).

16. The method of any one of the previous claims, wherein the gelatin-comprising composition further comprises a superdisintegrant.

17. A gummy composition prepared by any one of claims 1-16.

18. A blister comprising the gummy composition of claim 17.

19. The blister of claim 18, wherein the blister is part of a blister pack comprising one or more blisters.

20. A gelatin-comprising composition comprising:60-95 wt. % one or more sweetener;1-15 wt. % gelatin; and0.01-10 wt. % one or more API.

21. The gelatin-comprising composition of claim 20, wherein the composition is a compressed tablet or a powder.

22. The gelatin-comprising composition of any one of claims 20 or 21, wherein the one or more API comprises loratadine, acetaminophen, a vitamin, a vitamin mixture, or a combination thereof.

23. The gelatin-comprising composition of any one of claims 20-22, wherein the one or more sweetener comprises compressible sugar.

24. The gelatin-comprising composition of any one of claims 20-23, wherein the composition further comprises one or more preservative, such as citric acid anhydrous.

25. The gelatin-comprising composition of any one of claims 20-24, wherein the composition further comprises a superdisintegrant.

26. The gelatin-comprising compositions of any one of claims 20-25, wherein the composition further comprises a taste-masking agent.

27. A blister comprising the gelatin-comprising composition of any one of claims 20-26.

28. The blister of claim 27, wherein the blister is part of blister pack comprising one or more blisters.

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