Coated solid dosage forms

Patent metadata

Field	Value
Publication number	US-9421171-B2
Application number	US-201213371652-A
Country	US
Kind code	B2
Filing date	Feb 13, 2012
Priority date	Feb 14, 2011
Publication date	Aug 23, 2016
Grant date	Aug 23, 2016

Abstract

The invention is associated with ingestible film coated solid dosage forms comprising natural honey in the coating applied to such forms. The natural honey of the film coated solid dosage form is of sufficient level to be perceived by the user while avoiding sticking to each other or the packaging with which they are in contact and, or storage.

First claim

What is claimed is:

1. A solid dosage form comprising:
a film coating wherein the film coating comprises from about 10% to about 25% sticky natural honey; and
an inner core;
wherein the solid dosage form has a static coefficient of friction value from about 0.15 to about 0.40 and wherein the film coating does not comprise powdered honey solids.

2. The solid dosage form of claim 1 wherein the film coating comprises from about 13% to about 18% sticky natural honey.

3. The solid dosage form of claim 1 wherein the film coating comprises from about 13% to about 23% sticky natural honey.

4. The solid dosage form of claim 1 wherein the film coating comprises from about 13% to about 20% sticky natural honey.

5. The solid dosage form of claim 2 wherein the solid dosage form has a static coefficient of friction value from about 0.15 to about 0.30.

6. The solid dosage form of claim 1 wherein the inner core comprises an active.

7. The solid dosage form of claim 6 wherein the active is selected from the group consisting of decongestants, pain relievers, antitussives, antihistamines, expectorants and combinations thereof.

8. The solid dosage form of claim 6 wherein the active comprises a decongestant, a pain reliever, and an antitussive.

9. The solid dosage form of claim 8 wherein the decongestant is selected from the group consisting of phenylephrine hydrochloride, pseudoephedrine hydrochloride, and combinations thereof; the pain reliever is selected from the group consisting of acetaminophen, ibuprofen, and combinations thereof, and the antitussive is dextromethorphan.

10. The solid dosage form of claim 1 wherein the film coating further comprises from about 0.05% to about 5% sweetener, by weight of the film coating.

11. The solid dosage form of claim 10 wherein the sweetener is sucralose.

12. The solid dosage form of claim 1 wherein the solid dosage form tastes like honey.

13. The solid dosage form of claim 1 wherein the film coating further comprises from about 0.5% to about 3.0% of a colorant, by weight of the film coating.

14. The solid dosage form of claim 1 wherein the film coating further comprises propylene glycol.

15. The solid dosage form of claim 1 wherein the solid dosage form is a compressed tablet.

16. A tablet comprising:
a film coating wherein the film coating comprises from about 10% to about 25% sticky natural honey and from about 0.05% to about 5% sweetener; and
an inner core comprising an active;
wherein the solid dosage form has a static coefficient of friction value from about 0.15 to about 0.40 and wherein the tablet tastes like honey.

17. The tablet of claim 16 wherein the active is selected from the group consisting of decongestants, pain relievers, antitussives, antihistamines, expectorants and combinations thereof.

18. The tablet of claim 16 wherein the active comprises a decongestant, a pain reliever, and an antitussive.

19. The solid dosage form of claim 16 wherein the film coating comprises from about 13% to about 18% sticky natural honey.

20. The solid dosage form of claim 19 wherein the solid dosage form has a static coefficient of friction value from about 0.15 to about 0.30.

21. A process of making the solid dosage form of claim 1 wherein the film coating is applied by spray drying and the liquid film coating comprises from about 13% to about 21% solids.

22. The process of claim 21 wherein the liquid film coating comprises from about 13% to about 18% solids.

Assignees

• Stella Mark Edward
• Knights Elissa Nicole
• Procter & Gamble

Inventors

• Stella Mark Edward
• Knights Elissa Nicole

Classifications

• A61P29/00

  Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] · CPC title

• A61K31/485

  Morphinan derivatives, e.g. morphine, codeine · CPC title

• A61P11/00

  Drugs for disorders of the respiratory system · CPC title

• A61K31/137

  Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone} · CPC title

• A61K31/09

  having two or more such linkages · CPC title