Multicomponent gummy compositions with hard core

Patent metadata

Field	Value
Publication number	US-2016296474-A1
Application number	US-201615092283-A
Country	US
Kind code	A1
Filing date	Apr 6, 2016
Priority date	Apr 7, 2015
Publication date	Oct 13, 2016
Grant date	—

Abstract

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.

First claim

1 . A chewable, multicomponent composition for oral administration, the multicomponent composition comprising:
a first component that is a gummy composition; a second component that is in the form of a particulate material or is a pre-formed solid unit or plurality of pre-formed solid units; 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 substantially 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 the gummy composition comprises 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.

8 . The multicomponent composition of claim 7 , 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.

9 . 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.

10 . 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.

11 . The multicomponent composition of claim 1 , wherein the second composition is a pre-formed tablet having a hardness of about 2 Kp to about 35 Kp.

12 . The multicomponent composition of claim 11 , wherein one or more of the following conditions is met:
the pre-formed tablet is orally disintegrable or dissolvable; the pre-formed tablet has a hardness of about 4 Kp to about 20 Kp; the pre-formed tablet, prior to combination with the first component, is fracturable and has a brittleness index of about 0.5 to about 0.95.

13 . The multicomponent composition of claim 11 , 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.

14 . The multicomponent composition of claim 11 , 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%.

15 . The multicomponent composition of claim 11 , 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.

16 . The multicomponent composition of claim 1 , wherein the second composition is a pre-formed unit of a chewy composition having a hardness of about 4 Kp to about 20 Kp.

17 . The multicomponent composition of claim 16 , wherein the pre-formed unit of the chewy composition comprises about 10% to about 60% w/w of one or more bulking agents, about 5% to about 60% w/w of one or more hydrophilic polymers, about 0.05% to 5% of one or more processing aids, optionally one or more disintegrants, and the active agent in an amount of about 0.1% to about 60% w/w.

18 . The multicomponent composition of claim 16 , wherein one or both of the following conditions is met:
the pre-formed unit of the chewy composition is water stable such that, separate from the first component, the chewy composition absorbs less than about 10% by weight of water (based on the weight of the chewy composition) over a time of 5 days at a temperature of 40° C. and a relative humidity of 75%; the pre-formed unit of the chewy composition is stable such that the active ingredient exhibits substantially no degradation when the chewy composition is stored for a time of 11 days at a temperature of 40° C. and a relative humidity of 75%.

19 . The multicomponent composition of claim 16 , wherein the pre-formed unit of the chewy composition has a diameter of about 6 mm to about 12 mm and a thickness of about 0.5 mm to 8 mm.

20 . 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.

21 . The multicomponent composition of claim 20 , wherein the one or more lipidic materials are selected from the group consisting of vegetable fats, nut fats, seed fats, and combinations thereof.

22 . The multicomponent composition of claim 20 , wherein the one or more lipidic materials comprises cocoa fat.

23 . The multicomponent composition of claim 20 , 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.

24 . The multicomponent composition of claim 20 , wherein the active ingredient is present in the pre-formed unit of the lipidic composition, and wherein the pre-formed unit of the lipidic co

Assignees

• Church & Dwight Co Inc

Inventors

• Romanoschi Ovidiu
• Oryniak Caryn
• Muniz Luis C
• Huatan Hiep
• Kanji Nazim
• Jones Huw
• Bagley Lindsey
• Godfrey Graham

Classifications

• A61P11/02

  Nasal agents, e.g. decongestants · CPC title

• A61K31/375

  Ascorbic acid, i.e. vitamin C; Salts thereof · CPC title

• A61K9/2027

  obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates · CPC title

• A23G3/54

  Composite products, e.g. layered, coated, filled · CPC title

• A61K9/0056 Primary

  Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals · CPC title