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Claims for Patent: 5,075,114

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Claims for Patent: 5,075,114

Title: Taste masking and sustained release coatings for pharmaceuticals
Abstract:Chewable medicament tablets are made from coated granules of a medicament wherein the coating on said granules comprises a blend of cellulose actate and/or cellulose acetate butyrate and hydroxypropyl cellulose and a process for making such tablets and a method of providing sustained release of medicaments utilizing such coated granules in a tablet.
Inventor(s): Roche; Edward J. (Hawthorne Place, PA)
Assignee: McNeil-PPC, Inc. (Milltown, NJ)
Application Number:07/528,003
Patent Claims: 1. A chewable tablet of a medicament comprising compressed coated granules, said coated granules individually comprising medicament coated with from about 5 to about 28% of the total dry weight of the coated medicament granule of a polymer blend of: (a) cellulose acetate, cellulose acetate butyrate and combinations thereof; and (b) hydroxypropyl cellulose wherein the ratio of cellulose acetate, cellulose acetate butyrate and combinations thereof to hydroxypropyl cellulose is in the range of about 97/3 to about 50/50.

2. The chewable tablet of claim 1 wherein the medicament is selected from the group consisting of ibuprofen, acetaminophen, aspirin, naproxen, pseudoephedrine, dextromethorphan, chlorpheniramine, loperamide, diphenhydramine, famotidine, cimetidine, ranitidine, nizatidine, salts thereof, and combinations thereof.

3. The chewable tablet of claim 1 wherein the polymer blend is intended for sustained release and contains from about 3 to about 15 weight percent of hydroxypropyl cellulose.

4. The chewable tablet of claim 1 wherein the coated granules are intended for sustained release and contain from about 16 to about 28 percent of said polymer blend.

5. The chewable tablet of claim 1 wherein the coated granules are intended for taste mask and contain from about 8 to about 15 weight percent of the polymer blend.

6. The chewable tablet of claim 1 wherein the medicament comprises ibuprofen.

7. The chewable tablet of claim 1 wherein the medicament comprises dexibuprofen lysine.

8. The chewable table of claim 1 wherein the medicament comprises ibuprofen.

9. The chewable table of claim 1 wherein the medicament comprises a combination of ibuprofen and pseudoephedrine.

10. The chewable table of claim 1 wherein the medicament comprises loperamide.

11. The chewable tablet of claim 1 wherein the medicament comprises acetaminophen and diphenhydramine hydrochloride or citrate.

12. The chewable tablet of claim 1 wherein the medicament comprises a combination of acetaminophen, pseudoephedrine, dextromethorphan and chlorpheniramine.

13. The chewable tablet of claim 1 wherein the medicament is a combination of an analgesic selected from the group consisting of ibuprofen, acetaminophen and aspirin; with pseudoephedrine; chlorpheniramine, and dextromethorphan.

14. A process of preparing a chewable medicament tablet comprising the steps of:

coating medicament granules with from about 5 to about 28% of the total dry weight of the coated medicament granule with a polymer blend of cellulose acetate, cellulose acetate butyrate or a combination thereof and hydroxypropyl cellulose wherein the ratio of cellulose acetate, cellulose acetate butyrate and combinations thereof to hydroxypropyl cellulose is in the range of about 97/3 to about 50/50; and forming a chewable tablet by compressing the coated medicament in the presence of excipients.

15. A method for taste masking medicaments comprising coating a medicament composition with a taste masking effective amount of a polymer blend of cellulose acetate, cellulose acetate butyrate, or combination thereof and hydroxypropyl cellulose.

16. The method of claim 15 wherein the medicament coated is selected from the group consisting of ibuprofen, aspirin, naproxen, acetaminophen, loperamide, pseudoephedrine, dextromethorphan, chlorpheniramine, diphenhydramine, famotidine, cimetidine, ranitidine, nizatidine, salts thereof, and mixtures thereof.

17. The method of claim 15 wherein the medicament is dexibuprofen lysine.

18. A method of providing sustained release of a medicament comprising coating a medicament with a sustained release effective amount of a polymer blend of cellulose acetate, cellulose acetate butyrate or combination thereof and hydroxypropyl cellulose.

19. The method of claim 18 wherein the medicament is selected from the group consisting of ibuprofen, aspirin, naproxen, acetaminophen, loperamide, pseudoephedrine, dextromethorphan, chlorpheniramine, diphenhydramine, famotidine, cimetidine, ranitidine, nizatidine, salts thereof, and mixtures thereof.
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