Multicomponent gummy compositions with hard core
The present disclosure provides oral, chewable dosage forms that are suitable for delivery of one or more active ingredients to a consumer, particularly a human individual. The dosage forms can be configured as multicomponent compositions formed of: a first component including a gummy composition; a second component that is a particulate material or is a pre-formed solid unit or plurality of pre-formed solid units; and an active ingredient. The second component can be, for example, in the form of a pharmaceutically acceptable oral dosage unit, such as a tablet, a caplet, a soft shell capsule, a hard shell capsule, a microcapsule, or a pastille.
1. A chewable, multicomponent composition for oral administration, the multicomponent composition comprising:
a first component that is a hydrocolloid system comprising about 70% to about 94% w/w of one or more hydrophilic bulking agents, about 1% to about 20% w/w of one or more hydrophilic, long-chain polymers, and about 5% to about 35% w/w of a water source, the first component being in the form of a gel;
a second component that is a solid unit or plurality of solid units in the form of a pre-formed tablet having a hardness of about 2 Kp to about 20 Kp; and
an active ingredient;
wherein the first component comprises at least a portion of an outer surface of the multicomponent composition.
2. The multicomponent composition of claim 1 , wherein the first component completely surrounds the second component such that the first component is a shell surrounding at least one core formed of the second component.
3. The multicomponent composition of claim 2 , further comprising a third component configured as a layer between the first component and the second component.
4. The multicomponent composition of claim 3 , wherein the third component is configured as a barrier layer that substantially prevents passage of water between the first component and the second component.
5. The multicomponent composition of claim 1 , wherein one or more of the following conditions is met:
the active ingredient is included in the second component;
the active ingredient is included in the first component;
the active ingredient is in an encapsulated form;
the gummy composition is elastic or viscoelastic;
the multicomponent composition further comprises an outer layer surrounding the first component and the second component.
6. The multicomponent composition of claim 1 , wherein the active ingredient is a natural or synthetic substance that is recognized as being beneficial to human health and is selected from the group consisting of non-steroidal anti-inflammatory drugs (NSAIDs), analgesics, antihistamines, decongestants, antitussives, expectorants, sleep aids, antibiotics, laxatives, anti-diarrheals, anthelmintics, antacids, vitamins, minerals, phytonutrients, fiber, fatty acids, amino acids, polypeptides, botanicals, herbs, prebiotics, probiotics, and combinations thereof.
7. The multicomponent composition of claim 1 , wherein one or more of the following conditions is met:
the one or more hydrophilic bulking agents includes one or more saccharides or saccharide derivatives;
the one or more hydrophilic bulking agents includes one or more hydrogenated carbohydrates;
the one or more hydrophilic bulking agents includes one or both of sugar solids and granulated sugar;
the one or more hydrophilic bulking agents includes glucose, sucrose, and sorbitol.
8. The multicomponent composition of claim 1 , wherein the second composition comprises one or more ingredients selected from the group consisting of saccharides, saccharide derivatives, lipids, cellulosic polymers, cellulosic polymer derivatives, inorganic salts, and combinations thereof.
9. The multicomponent composition of claim 1 , wherein the second composition is a pre-formed solid unit in the form of one or more of a tablet, a caplet, a hard shell capsule, a soft shell capsule, a microcapsule, and a pastille.
10. The multicomponent composition of claim 1 , wherein the pre-formed tablet comprises about 5% to about 80% w/w of one or more bulking agents, about 0.1% to about 15% w/w of one or more disintegrants, about 0.05% to about 5% w/w of one or more processing aids, and the active ingredient in an amount of about 0.1% to about 60% w/w.
11. The multicomponent composition of claim 1 , wherein one or both of the following conditions is met:
the pre-formed tablet is stable such that the active ingredient exhibits substantially no degradation when the core composition is stored for a time of 20 days at a temperature of 40° C. and a relative humidity of 75%;
the pre-formed tablet is stable such that, separate from the first component, the pre-formed tablet absorbs less than about 5% by weight of water (based on the weight of the tabletted composition) over a time of 14 days at a temperature of 40° C. and a relative humidity of 75%.
12. The multicomponent composition of claim 1 , wherein the pre-formed tablet has a diameter of about 6 mm to about 12 mm and a thickness of about 0.5 mm to 8 mm; or wherein the pre-formed tablet has a diameter of about 2 mm to about 10 mm and a thickness of about 0.5 mm to 6 mm.
13. The multicomponent composition of claim 1 , wherein the second composition is a pre-formed unit of a lipidic composition that comprises one or more lipidic materials and one or more bulking agents.
14. The multicomponent composition of claim 13 , wherein the one or more lipidic materials are selected from the group consisting of vegetable fats, nut fats, seed fats, and combinations thereof.
15. The multicomponent composition of claim 13 , wherein the one or more lipidic materials comprises cocoa fat.
16. The multicomponent composition of claim 13 , wherein the pre-formed unit of the lipidic composition comprises about 10% to about 60% w/w of the one or more lipid materials and about 10% to about 60% w/w of the one or more bulking agents.
17. The multicomponent composition of claim 13 , wherein the active ingredient is present in the pre-formed unit of the lipidic composition, and wherein the pre-formed unit of the lipidic composition is stable such that, after being stored for a time of 28 days at a temperature of 50° C. and a relative humidity of 60%, the pre-formed unit of the lipidic composition comprises less than about 2% by weight of active ingredient degradation products relative to the weight of the active ingredient.
18. The multicomponent composition of claim 13 , wherein the pre-formed unit of the lipidic composition has a diameter of about 0.5 mm to about 10 mm.
19. The multicomponent composition of claim 1 , wherein the second composition is in the form of a particulate material.
20. The multicomponent composition of claim 19 , wherein the particulate material is in the form of a powder, granules, beads, or combinations thereof.
21. The multicomponent composition of claim 1 , wherein the first component is hydrocolloid system comprising about 70% to about 94% w/w of one or more saccharides or saccharide derivatives, about 1% to about 15% w/w of one or more hydrophilic, long-chain polymers comprising at least pectin, and about 10% to about 25% w/w of a water source, the first component being in the form of a gel.
22. The multicomponent composition of claim 1 , wherein the first component is one or both of configured to be reduced to smaller pieces through mastication and configured to dissolve within the mouth.