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Claims for Patent: 5,716,641

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Claims for Patent: 5,716,641

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 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 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)
Application Number:08/619,116
Patent Claims: 1. A method of enhancing the dissolution profile of a pharmaceutical from a solid dosage form comprising the pharmaceutical and simethicone, comprising:

providing the pharmaceutical in a first portion of said dosage form, said pharmaceutical is selected from the group consisting of diphenoxylate, loperamide and loperamide-N-oxide, pharmaceutically acceptable salts thereof, and combinations thereof;

providing the simethicone in a second portion of said dosage form; and

separating said first and second portions with a pharmaceutically acceptable polymeric barrier which is impermeable to simethicone and the pharmaceutical.

2. The method 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 method of claim 1 wherein the pharmaceutical comprises loperamide HCl.

4. The method of claim 1 wherein the pharmaceutical comprises diphenoxylate.

5. The method of claim 1 wherein the pharmaceutical comprises loperamide-N-oxide.

6. The method of claim 1 wherein the barrier is a pharmaceutically acceptable film forming polymer.

7. A method of enhancing the dissolution profile of a pharmaceutical from a solid dosage form comprising the pharmaceutical and simethicone, comprising:

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 method 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 method of claim 8 wherein the pharmaceutical comprises loperamide HCl.

10. The method of claim 7 wherein the pharmaceutical comprises diphenoxylate.

11. The method of claim 8 wherein the pharmaceutical comprises loperamide-N-oxide.

12. The method of claim 7 wherein the nonenteric polymeric coating comprises cellulose acetate, methylaminoethyl-methacrylate and neutral methacrylic acid ester and the pharmaceutical comprises loperamide HCl.
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