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|Title:||Simethicone containing pharmaceutical compositions|
|Abstract:||A method of making solid oral dosage form for the treatment of gastrointestinal disorders comprising a therapeutically effective amount of a pharmaceutical suitable for the treatment of gastric disorders selected from the group consisting of cimetidine, ranitidine, famotidine, diphenoxylate, loperamide, loperamide-N-oxide, pharmaceutically acceptable salts thereof and combinations thereof; and a therapeutically effective amount of simethicone wherein the pharmaceutical and simethicone are separated by a barrier. The barrier is formed by coating with a polymer impermeable to simethicone.|
|Inventor(s):||Stevens; Charles A. (Lansdale, PA), Hoy; Michael R. (North Wales, PA), Roche; Edward J. (Paoli, PA)|
|Assignee:||McNeil-PPC, Inc. (Skillman, NJ)|
|Filing Date:||May 31, 1995|
|Claims:||1. A method for manufacturing a multilayered solid dosage form having one layer containing simethicone and one layer containing a pharmaceutical for treating gastric disorders selected from the group consisting of cimetidine, ranitidine, famotidine, diphenoxylate, loperamide, loperamide-N-oxide, pharmaceutically acceptable salts thereof and combinations thereof with a barrier sandwiched between the two layers comprising pressing one of two granulations each containing pharmaceutically acceptable excipients with either a therapeutic amount of simethicone or a therapeutic amount of said pharmaceutical for the treatment of a gastric disorder therein, to form a first layer with one exposed surface; forming said barrier by coating the exposed surface with a pharmaceutically acceptable polymer which is substantially impermeable to simethicone to form a coated layer with coated surface; contacting the coated surface with the remaining granulation; and pressing the granulation and coated layer to form a multilayered solid oral dosage form wherein the simethicone and the pharmaceutical are separated by the polymer substantially impermeable to simethicone. |
2. The method of claim 1 wherein the pharmaceutical comprises loperamide HCl.
3. The method of claim 1 wherein the pharmaceutical comprises diphenoxylate.
4. The method of claim 1 wherein the pharmaceutical comprises famotidine.
5. The method of claim 1 wherein the pharmaceutical comprises loperamide-N-oxide.
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