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Details for Patent: 5,460,825

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Details for Patent: 5,460,825

Title: Taste mask coatings for preparing chewable pharmaceutical tablets
Abstract:Chewable medicament tablets are made from coated rotogranules of a medicament wherein the rotogranules are formed from a granulation mixture of: medicament, e.g. famotidine; binder, e.g. HPMC; and carrier, e.g. lactose; and the rotogranules are coated with cellulose acetate, cellulose acetate butyrate or a combination thereof and hydroxypropyl cellulose. A process for making such tablets and a method of providing taste masking of medicaments utilizing such coated rotogranules.
Inventor(s): Roche; Edward J. (Paoli, PA), Papile; Susan M. (Blue Bell, PA), Freeman; Eleanor M. (Norristown, PA)
Assignee: McNeil-PPC, Inc. (Milltown, NJ)
Filing Date:Jul 23, 1993
Application Number:08/096,791
Claims:1. A process of preparing a chewable medicament tablet comprising the steps of:

rotogranulating a composition of in the range of from about 2 to about 85 percent of a medicament, in the range of from about 4 to about 10 percent of a binder and a in the range of from about 10 to about 94 percent of a fine particulate carrier having a particle size from about 5 to about 75 microns to provide granules;

coating the granules with a polymer blend composed of a polymer selected from the group consisting of cellulose acetate, cellulose acetate butyrate and a combination of both blended with hydroxypropyl cellulose to form coated granules; and

forming a chewable tablet by compressing the coated granules with tableting excipients.

2. The process of claim 1 wherein the polymer blend has a weight ratio in the range of about 95:5 to 50:50 of a polymer selected from the group consisting of cellulose acetate, cellulose acetate butyrate and a combination thereof to hydroxypropyl cellulose.

3. The process of claim 2 wherein the polymer blend comprises about an 70:30 blend of cellulose acetate:hydroxypropyl cellulose and comprises about from 5 to 20% by weight of the total weight of the coated rotogranulation composition.

4. A method for taste masking medicaments comprising rotogranulating a medicament with hydroxypropylmethyl-cellulose and a fine particulate lactose having a particle size from about 5 to about 75 microns to form granules and coating the granules with a taste masking effective amount of polymer blend composed of a polymer selected from the group consisting of cellulose acetate, cellulose acetate butyrate and a combination thereof blended with hydroxypropyl cellulose.

5. The method of claim 4 wherein the medicament is selected from the group consisting of famotidine, loperamide, cimetidine, ranitidine, salts thereof and combinations thereof.

6. The method of claim 4 wherein the medicament is famotidine.
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