Details for Patent: 5,980,944
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| Title: | Simethicone containing pharmaceutical compositions |
| Abstract: | A 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 granules of 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 coat on the granules which is substantially 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: | Nov 25, 1997 |
| Application Number: | 08/978,358 |
| Claims: | 1. A solid oral dosage form for the treatment of gastrointestinal distress comprising simethicone and a pharmaceutical having an enhanced dissolution profile, comprising a therapeutically effective amount of a pharmaceutical for the treatment of gastric disorders selected from the group consisting of diphenoxylate, loperamide and loperamide-N-oxide, pharmaceutically acceptable salts thereof, and combinations thereof; wherein the pharmaceutical is provided in the form of coated granules which are coated with a nonenteric polymer coating impermeable to simethicone; a therapeutically effective amount of simethicone free of said nonenteric coating; and pharmaceutically acceptable excipients. 2. The solid oral dosage form of claim 1 wherein the pharmaceutical is selected from the group consisting of loperamide, loperamide-N-oxide, pharmaceutically acceptable salts thereof and combinations thereof. 3. The solid oral dosage form of claim 1 wherein the pharmaceutical comprises loperamide HCl. 4. The solid oral dosage form of claim 1 wherein the pharmaceutical comprises diphenoxylate. 5. The solid oral dosage form of claim 1 wherein the pharmaceutical comprises loperamide-N-oxide. 6. The solid oral dosage form of claim 1 wherein the nonenteric polymer coating comprises cellulose acetate, methylaminoethyl-methacrylate and neutral methacrylic acid ester and the pharmaceutical comprises loperamide HCl. 7. A solid oral dosage form for the treatment of gastrointestinal distress comprising simethicone and a pharmaceutical having an enhanced dissolution profile produced by the process comprising the steps of: substantially separating the pharmaceutical from simethicone by providing the pharmaceutical in the form of coated granules, wherein the coating is a nonenteric polymer coating impermeable to the pharmaceutical and simethicone, and the pharmaceutical is selected from the group consisting of diphenoxylate, loperamide and loperamide-N-oxide, pharmaceutically acceptable salts thereof, and combinations thereof; and providing the simethicone in a form free of said nonenteric coating. 8. The solid oral dosage form of claim 7 wherein the pharmaceutical is selected from the group consisting of loperamide, loperamide-N-oxide, pharmaceutically acceptable salts thereof and combinations thereof. 9. The solid oral dosage form of claim 7 wherein the pharmaceutical comprises loperamide HCl. 10. The solid oral dosage form of claim 7 wherein the pharmaceutical comprises diphenoxylate. 11. The solid oral dosage form of claim 7 wherein the pharmaceutical comprises loperamide-N-oxide. 12. The solid oral dosage form of claim 7 wherein the nonenteric polymeric coating comprises cellulose acetate, methylaminoethyl-methacrylate and neutral methacrylic acid ester and the pharmaceutical comprises loperamide HCl. |
