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Claims for Patent: 5,489,436

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Claims for Patent: 5,489,436

Title: Taste mask coatings for preparation of chewable pharmaceutical tablets
Abstract:Chewable tablets are made from a coated medicament wherein the coating comprises a mixture of dimethylaminoethyl methacrylate and neutral methacrylic acid ester and a cellulose ester, e.g. cellulose acetate, cellulose acetate butyrate, cellulose triacetate or a combination thereof and optionally polyvinyl pyrrolidone, and a process for making such tablets and a method of providing taste masking and sustained releasing of medicaments utilizing such coatings.
Inventor(s): Hoy; Michael R. (Sellersville, PA), Roche; Edward J. (Paoli, PA)
Assignee: McNeil-PPC, Inc. (Milltown, NJ)
Application Number:08/166,111
Patent Claims: 1. A chewable medicament tablet comprising a medicament composition coated with a taste masking effective amount of a polymer blend consisting essentially of from about 5 to about 95 weight percent by total weight of the polymer blend of dimethylaminoethyl methacrylate and neutral methacrylic acid ester and from about 5 to about 95 percent by total weight of the polymer blend of a polymer selected from the group consisting of cellulose acetate, cellulose triacetate or a combination thereof.

2. The chewable tablet of claim 1 wherein the polymer blend coating comprises from about 2 to 55% by weight of the total weight of the coated medicament composition.

3. The chewable tablet of claim 1 wherein the polymer blend consists essentially of about 10 to about 90% of dimethylaminoethyl methacrylate and neutral methacrylic acid ester and about 10 to about 90% of cellulose acetate or cellulose triacetate, by weight of the total weight of the polymer blend.

4. The chewable tablet of claim 1 wherein the medicament composition to be coated is spherical in shape.

5. The chewable tablet of claim 2 wherein the medicament composition comprises a medicament selected from the group consisting of acetaminophen, ibuprofen, dexibuprofen lysinate, naproxen, naproxen sodium, psyllium, chlorpheniramine, astemizole, loperamide, famotidine, ranitidine, cimetidine, pseudoephedrine, salts thereof and combinations thereof.

6. The chewable tablet of claim 3 wherein the medicament is selected-from the group consisting of acetaminophen, ibuprofen, dexibuprofen lysinate, naproxen, naproxen sodium, psyllium, chlorpheniramine, astemizole, loperamide, famotidine, ranitidine, cimetidine, pseudoephedrine, salts thereof and combinations thereof.

7. The chewable tablet of claim 6 wherein the tablet additionally comprises pharmaceutically acceptable excipients.

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

coating a medicament composition with a taste masking effective amount of polymer blend consisting essentially of about 5 to about 95 weight percent by total weight of the polymer blend of dimethylaminoethyl methacrylate and neutral methacrylic acid ester and about 5 to about 95 weight percent by total weight of the polymer blend of a polymer selected from the group consisting of cellulose acetate, cellulose triacetate and combinations thereof; and forming a chewable tablet by compressing the coated medicament composition in the presence of excipients.

9. The process of claim 8, further comprising the step of granulating the medicament to form said medicament composition.

10. The process of claim 8 wherein the polymer coating comprises from 2 to 55% by weight of total weight of the coated medicament composition.

11. A method for taste masking medicaments comprising coating a medicament composition with a taste masking effective amount of a polymer blend consisting essentially of from about 5 to about 95 weight percent by total weight of the polymer blend of dimethylaminoethyl methacrylate and neutral methacrylic acid ester and about 5 to about 95 weight percent by total weight of the polymer blend of a polymer selected from the group consisting of cellulose acetate, cellulose triacetate and combinations thereof.

12. The method of claim 11 wherein the medicament composition comprises a medicament selected from the group consisting of acetaminophen, ibuprofen, ibuprofen sodium, dexibuprofen lysinate, naproxen, naproxen sodium, psyllium chlorpheniramine, astemizole, loperamide, famotidine, ranitidine, cimetidine, pseudoephedrine salts thereof and combinations thereof.
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