Pharmaceutical compositions of a non-enteric coated proton pump inhibitor with a carbonate salt and bicarbonate salt combination

• US 20020192299A1
• Filed: 12/26/2001
• Published: 12/19/2002
• Est. Priority Date: 12/28/2000
• Status: Abandoned Application

• Current Assignee: TAP Pharmaceutical Products Incorporated
• Original Assignee: TAP Pharmaceutical Products Incorporated
• Inventors: Taneja, Rajneesh, Gupta, Pramod
• Application Number:
  US10/036,129
• Publication Number:
  US 20020192299A1
• Time in Patent Office: Days
• US Class Current: 424/717
• CPC Class Codes: A61K 31/4439 containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole nicotine A61K31/465
• CPC Class Codes: A61K 9/0095 Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006
• CPC Class Codes: A61K 9/1611 Inorganic compounds
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants

Abstract

A method for treating gastric acid disorders with a non-enteric coated proton pump inhibitor in a pharmaceutically acceptable carrier including a bicarbonate salt of a Group IA metal and a carbonate salt of a Group IA metal; and a pharmaceutical composition of a non-enteric coated proton pump inhibitor in a pharmaceutically acceptable carrier including a bicarbonate salt of a Group IA metal and a carbonate salt of a Group IA metal are disclosed. A presently preferred proton pump inhibitor is lansoprazole, a presently preferred bicarbonate salt is sodium bicarbonate, and a presently preferred carbonate salt is sodium carbonate. The composition is a fast-acting formulation which reduces the undesirable belching associated with proton pump inhibitor formulations that contain high doses of sodium bicarbonate.

Claims

1. A method for treating gastric acid disorders comprising the step of administering to a patient in need of such treatment a therapeutically effective amount of at least one non-enteric coated proton pump inhibitor in a pharmaceutically acceptable carrier;

wherein said pharmaceutically acceptable carrier includes a bicarbonate salt of a Group IA metal and a carbonate salt of a Group IA metal.

2. The method of claim 1 wherein said Group IA metal of said bicarbonate salt is sodium.

3. The method of claim 1 wherein said Group IA metal of said carbonate salt is sodium.

4. The method of claim 1 wherein said Group IA metal of said bicarbonate salt is potassium.

5. The method of claim 1 wherein said Group IA metal of said carbonate salt is potassium.

6. The method of claim 1 wherein said non-enteric coated proton pump inhibitor is a substituted benzimidazole or pharmaceutically acceptable salt thereof.

7. The method of claim 6 wherein said substituted benzimidazole is lansoprazole or a pharmaceutically acceptable salt thereof.

8. The method of claim 1 wherein the molar ratio of said bicarbonate salt of said Group IA metal to said carbonate salt of said Group IA metal is one to one.

9. The method of claim 2 wherein said bicarbonate salt of said Group IA metal is sodium bicarbonate.

10. The method of claim 3 wherein said carbonate salt of said Group IA metal is sodium carbonate.

11. The method of claim 9 wherein said pharmaceutically acceptable carrier contains from about 125 mg to about 1000 mg of sodium bicarbonate.

12. The method of claim 10 wherein said pharmaceutically acceptable carrier contains from about 125 mg to about 1000 mg of sodium carbonate.

14. The method of claim 13 wherein said pharmaceutically acceptable carrier contains from about 125 mg to about 1000 mg of sodium carbonate, and from about 125 mg to about 1000 mg of sodium bicarbonate.

16. The composition of claim 15 wherein said Group IA metal of said bicarbonate salt is sodium.

17. The composition of claim 15 wherein said Group IA metal of said carbonate salt is sodium.

18. The composition of claim 15 wherein said Group IA metal of said bicarbonate salt is potassium.

19. The composition of claim 15 wherein said Group IA metal of said carbonate salt is potassium.

20. The composition of claim 15 wherein said non-enteric coated proton pump inhibitor is a substituted benzimidazole or pharmaceutically acceptable salt thereof.

21. The composition of claim 20 wherein said benzimidazole is lansoprazole or a pharmaceutically acceptable salt thereof.

22. The composition of claim 15 wherein the molar ratio of said bicarbonate salt of said Group IA metal to said carbonate salt of said Group IA metal is one to one.

23. The composition of claim 16 wherein said bicarbonate salt of said Group IA metal is sodium bicarbonate.

24. The composition of claim 17 wherein said carbonate salt of said Group IA metal is sodium carbonate.

25. The composition of claim 15 wherein said pharmaceutically acceptable carrier contains from about 125 mg to about 1000 mg of sodium carbonate and from about 125 mg to about 1000 mg of sodium bicarbonate.

27. The composition of claim 26 wherein said bicarbonate salt of said Group IA metal is sodium bicarbonate.

28. The composition of claim 26 wherein said carbonate salt of said Group IA metal is sodium carbonate.

29. The composition of claim 26 having from about 125 mg to about 11000 mg of sodium carbonate, and from about 125 mg to about 11000 mg of sodium bicarbonate.

13. A method for treating gastric acid disorders comprising the step of administering to a patient in need of such treatment a therapeutically effective amount of non-enteric coated lansoprazole or a pharmaceutically acceptable salt thereof in a pharmaceutically acceptable carrier;

wherein said pharmaceutically acceptable carrier includes an equimolar ratio of sodium carbonate to sodium bicarbonate.

15. A pharmaceutical composition comprising:

at least one non-enteric coated proton pump inhibitor in a pharmaceutically acceptable carrier;

wherein said pharmaceutically acceptable carrier includes a bicarbonate salt of a Group IA metal and a carbonate salt of a Group IA metal.

26. A non-enteric coated lansoprazole composition consisting essentially of:

a) lansoprazole without enteric coating;

b) a bicarbonate salt of a Group IA metal; and

c) a carbonate salt of a Group IA metal.