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Claims for Patent: 5,612,054

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Claims for Patent: 5,612,054

Title: Pharmaceutical compositions for treating gastrointestinal distress
Abstract:This invention relates to a pharmaceutical composition for treating gastrointestinal distress comprising an effective amount of an antidiarrheal composition, e.g. loperamide, and an antiflatulent effective amount of simethicone and methods of treating gastrointestinal distress comprising administering such pharmaceutical compositions.
Inventor(s): Garwin; Jeffrey L. (Paoli, PA)
Assignee: McNeil-PPC, Inc. (Skillman, NJ)
Application Number:08/426,423
Patent Claims: 1. A composition for treating a human suffering from an intestinal disorder characterized by the symptoms of diarrhea and flatulence or gas comprising: an effective amount of an antidiarrheal compound selected from the group consisting of loperamide, bismuth subsalicylate, diphenoxylate, polycarbophil, their pharmaceutically acceptable salts and mixtures thereof; and an antiflatulent effective amount of simethicone.

2. The composition of claim 1 comprising from about 20 mg to about 125 mg of simethicone.

3. The composition of claim 2 comprising from about 0.5 mg to about 8.0 mg of loperamide.

4. The composition of claim 3 wherein the loperamide is in the form of a hydrochloride salt.

5. The composition of claim 3 wherein the loperamide is in an enterically coated form.

6. The composition of claim 5 wherein the loperamide and simethicone are in a solid dosage form.

7. The composition of claim 6 wherein the solid dosage form comprises at least a first layer and a second layer and the enterically coated loperamide is present in the first layer and simethicone is present in the second layer.

8. The composition of claim 2 comprising from about 120 mg to about 1200 mg of bismuth subsalicylate.

9. The composition of claim 8 comprising 300 mg of bismuth subsalicylate and 80 mg of simethicone.

10. The composition of claim 2 comprising from about 0.7 mg to about 10 mg of diphenoxylate.

11. The composition of claim 10 wherein the diphenoxylate is in the form of a hydrochloride salt.

12. The composition of claim 2 comprising about 150 mg to about 2000 mg of polycarbophil.

13. The composition of claim 12 wherein the polycarbophil is calcium polycarbophil.

14. The composition of claim 2 comprising 80 mg simethicone and 2 mg of loperamide.

15. The composition of claim 2 comprising 125 mg of simethicone and 2 mg of loperamide.

16. A composition for treating a human suffering from an intestinal disorder characterized by the symptoms of diarrhea and flatulence or gas comprising:

an effective amount of an enterically coated antidiarrheal compound selected from the group consisting of loperamide, bismuth subsalicylate, diphenoxylate, polycarbophil, their pharmaceutically acceptable salts, and mixtures thereof; and

an anti-flatulent effective amount of enterically coated simethicone.
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