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Claims for Patent: 5,098,715

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Claims for Patent: 5,098,715

Title: Flavored film-coated tablet
Abstract:The invention comprises a flavored thin film coating on solid oral dosage pharmaceutical tablets containing unpleasant tasting ingredients such as triprolidine hydrochloride and pseudoephedrine hydrochloride. The flavored coating of the invention is comprised of a film-forming substance such as a hydroxypropyl methylcellulose and a polyethylene glycol, a sweetening agent and a flavoring agent. The method of the invention comprises aqueous spray-coating of the flavored sweetened coating onto the pharmaceutical tablets.
Inventor(s): McCabe; Terrance T. (Durham, NC), Stagner; Robert A. (Greenville, NC), Sutton, Jr.; Joel E. (Greenville, NC)
Assignee: Burroughs Wellcome Co. (Research Triangle Park, NC)
Application Number:07/631,741
Patent Claims: 1. A pharmaceutical tablet comprising an unpleasant tasting, solid core and a flavored, pharmaceutically acceptable, thin film coating, said coating increasing the weight of the tablet by an average of about 5%, said coating comprising a water-soluble, film-forming polymer, a volatile flavoring agent and a sweetening agent, said coating being capable of masking the unpleasant taste of the core, and said coating having a flavor that is retained in the coating for at least about 24 months during storage and that provides a taste perception of said flavor for at least five seconds after oral administration of said tablet.

2. The pharmaceutical tablet of claim 1, wherein the core comprises triprolidine hydrochloride and pseudoephedrine hydrochloride.

3. The pharmaceutical tablet of claim 2, wherein the pharmaceutically acceptable, polymeric coating comprises hydroxypropyl methylcellulose and a plasticizing agent, the flavoring agent comprises peppermint flavoring and the sweetening agent comprises confectioners sugar.

4. The pharmaceutical tablet of claim 3, wherein the pharmaceutically acceptable, polymeric coating further contains titanium dioxide.

5. The pharmaceutical tablet of claim 2, wherein the pharmaceutically acceptable, polymeric coating comprises hydroxypropyl methylcellulose and a plasticizing agent, the flavoring agent comprises fruit flavoring and the sweetening agent comprises confectioners sugar.

6. The pharmaceutical tablet of claim 5, wherein the pharmaceutically acceptable, polymeric coating further contains titanium dioxide.

7. The pharmaceutical tablet of claim 1, wherein the core comprises triprolidine hydrochloride.

8. The pharmaceutical tablet of claim 1, wherein the core comprises pseudoephedrine hydrochloride.

9. A pharmaceutical tablet according to claim 1, wherein the film coating comprises hydroxypropyl methylcellulose.

10. A pharmaceutical tablet according to claim 9, wherein the sweetening agent comprises sucrose.

11. A pharmaceutical tablet according to claim 10, wherein the sweetening agent comprises confectioners sugar.

12. A pharmaceutical tablet according to claim 11, wherein the sweetening agent comprises about 2.5 per cent based on the weight of the film coating.

13. A pharmaceutical tablet according to claim 1, wherein the sweetening agent comprises about 2.5 per cent based on the weight of the film coating.

14. A method for preparing flavor-coated pharmaceutical tablets, comprising the steps of:

(a) preparing an aqueous dispersion comprising a pharmaceutically acceptable, film-forming substance, a volatile flavoring agent and sweetening agent, said film-forming substance comprising a water-soluble polymer;

(b) placing unpleasant tasting uncoated core tablets in a coating pan; and

(c) spray-coating the aqueous dispersion onto the exterior surface of the core tablets at a pan rotation speed and under air flow and temperature conditions sufficient to enable evaporation of water and even-coating of the core tablets, said conditions sufficient to provide a flavored coating that increases the weight of the tablet by an average of about 5%, said flavored coating being capable of masking the unpleasant taste of the core, and said flavored coating having a flavor that is retained in the coating for at least about 24 months during storage and that provides a taste perception of said flavor for at least five seconds after oral administration of said tablet.

15. The method of claim 14, wherein the pan is perorated and is rotated at about 8 rpm, the inlet airflow rate is about 1300 cubic feet per minute, the air temperature is about 90 degrees C., and the bed temperature is about 45 degrees C.

16. The method of claim 14, wherein:

(a) the pharmaceutically acceptable, polymeric, film-forming substance comprises hydroxypropyl methylcellulose, titanium dioxide and polyethylene glycol; and

(b) the aqueous dispersion is comprised of about 7.5% pharmaceutically acceptable, polymeric, film-forming substance, about 0.5% flavoring agent, and about 2.5% sweetening agent.

17. The method of claim 16, wherein the flavoring agent is peppermint flavoring.

18. The method of claim 16, wherein the flavoring agent is fruit flavoring.

19. The method of claim 14, wherein said core tablets comprise triprolidine hydrochloride and pseudoephedrine hydrochloride.

20. A method of claim 14, wherein the sweetening agent comprises sucrose.

21. A method according to claim 20, wherein the sweetening agent comprises confectioners sugar.

22. A method according to claim 14, wherein the film-forming substance comprises hydroxypropyl methylcellulose.

23. A pharmaceutical tablet comprising an unpleasant tasting, solid core and a flavored, pharmaceutically acceptable, thin film coating, wherein said coating has been formed by application of an aqueous dispersion of a water-soluble, polymeric film-forming substance, said coating increasing the weight of the tablet by an average of about 5%, said coating comprising a volatile flavoring agent and a sweetening agent, said coating being capable of masking the unpleasant taste of the core, and said coating having a flavor that is retained in the coating for at least about 24 months during storage and that provides a taste perception of said flavor for at least five seconds after oral administration of said tablet.
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