|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|
|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.