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Claims for Patent: 6,030,643

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Claims for Patent: 6,030,643

Title: Potassium, sodium and tris oxaprozin salt pharmaceutical formulations
Abstract:Pharmaceutical compositions containing potassium, sodium or Tris salt of oxaprozin as an active agent. The pharmaceutical compositions of the present invention are useful in eliminating or ameliorating pain and in the treatment of inflammation and inflammation associated disorders such as rheumatoid arthritis and osteoarthritis.
Inventor(s): Adams; Mark E. (Evergreen Park, IL), Desai; Subhash (Grayslake, IL), Karim; Aziz (Skokie, IL), Paul; Kalidas (Skokie, IL), Schaaf; Douglas J. (Elgin, IL), Zold; David J. (Prospect Heights, IL)
Assignee: G.D. Searle & Co. (Chicago, IL)
Application Number:08/857,999
Patent Claims: 1. A pharmaceutical composition in a solid dosage form comprising potassium, sodium or Tris salt of oxaprozin as an active agent, wherein the pharmaceutical composition contains less than 1% (w/w) magnesium stearate and wherein about 75% of the active agent in said solid dosage form becomes dissolved in 1000 ml of pH 7.4 phosphate buffer media at 37.degree. C. with paddle stirring at 75 rpm within about 30 minutes.

2. The pharmaceutical composition of claim 1, wherein the active agent is the potassium salt of oxaprozin.

3. The pharmaceutical composition of claim 1, wherein the active agent is the sodium salt of oxaprozin.

4. The pharmaceutical composition of claim 1, wherein the active agent is the Tris salt of oxaprozin.

5. The pharmaceutical composition of any one of claims 1-4, wherein the active agent is from about 37.14% to about 100% by weight of the total composition.

6. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition contains less than 2% (w/w) methylcellulose.

7. The pharmaceutical composition of claim 1, wherein said composition is substantially free of metallic stearates.

8. The pharmaceutical composition of claim 1, wherein the solid dosage form is a tablet, pill or caplet.

9. A pharmaceutical composition in a solid dosage form comprising (i) a potassium, sodium or Tris salt of oxaprozin as an active agent, and (ii) a lubricant selected from the group consisting of water-insoluble lubricants and water-soluble lubricants, wherein about 75% of the active agent in said solid dosage form becomes dissolved in 1000 ml of pH 7.4 phosphate buffer media at 37.degree. C. with paddle stirring at 75 rpm within about 30 minutes.

10. The pharmaceutical composition of claim 9, wherein the active agent is from about 37.14% to about 100% by weight of the total composition.

11. The pharmaceutical composition of claim 8, wherein the lubricant is from about 0.25% to about 20% by weight of the total composition.

12. The pharmaceutical composition of claim 9, wherein the pharmaceutical composition contains less than 1% (w/w) magnesium stearate.

13. The pharmaceutical composition of claim 9, wherein the pharmaceutical composition is substantially free of metallic stearates.

14. The pharmaceutical composition of claim 9, wherein the pharmaceutical composition contains less than 2% (w/w) methylcellulose.

15. The pharmaceutical composition of claim 11, wherein the solid dosage form is a tablet, pill or caplet.

16. The pharmaceutical composition of claim 9, wherein the water-insoluble lubricant is selected from the group consisting of calcium stearate, zinc stearate, stearic acid, hydrogenated vegetable oil and talc.

17. The pharmaceutical composition of claim 9, wherein the water-soluble lubricant is sodium lauryl sulfate or sodium stearyl fumarate.

18. The pharmaceutical composition of claim 9, further comprising a binder.

19. The pharmaceutical composition of claim 18, wherein the binder is from about 0.25% to about 30% by weight of the total composition.

20. The pharmaceutical composition of claim 19, wherein said binder is selected from the group consisting of cornstarch, pregelatinized cornstarch, sucrose, polyvinylpyrrolidone, methylcellulose, sodium carboxymethyl cellulose and ethylcellulose.

21. The pharmaceutical composition of claim 18, further comprising a filler.

22. The pharmaceutical composition of claim 21, wherein said filler is microcrystalline cellulose.

23. A pharmaceutical composition in a solid dosage form comprising (i) a potassium, sodium or Tris salt of oxaprozin as an active agent in an amount from about 70% to about 90% by weight of the composition; (ii) stearic acid in an amount from about 1% to about 4% by weight of the composition; (iii) pregelatinized corn starch in an amount of about 0.25% to about 25% by weight of the composition and (iv) optionally microcrystalline cellulose in an amount from about 0% to about 27% by weight of the composition, wherein about 75% of the active agent in said solid dosage form becomes dissolved in 1000 ml of pH 7.4 phosphate buffer media at 37.degree. C. with paddle stirring at 75 rpm within about 30 minutes.

24. The pharmaceutical composition of claim 23, wherein said active agent is potassium oxaprozin.

25. The pharmaceutical composition of claim 24, wherein said microcrystalline cellulose is present.

26. The pharmaceutical composition of claim 23, wherein the pharmaceutical composition contains less than 1% (w/w) magnesium stearate.

27. The pharmaceutical composition of claim 23, wherein the pharmaceutical composition is substantially free of metallic stearates.

28. The pharmaceutical composition of claim 23, wherein the pharmaceutical composition contains less than 2% w/w methylcellulose.

29. A method of eliminating or ameliorating pain in a mammal in need of such treatment comprising the step of administering to said mammal an effective amount of a pharmaceutical composition in a solid dosage form comprising potassium, sodium or Tris salt of oxaprozin as an active agent, wherein about 75% of the active agent in said solid dosage form becomes dissolved in 1000 ml of pH 7.4 phosphate buffer at 37.degree. C. with paddle stirring at 75 rpm within about 30 minutes.

30. The method of claim 29, wherein the active agent is from about 37.14% to about 100% by weight of the total composition.

31. The method of claim 29, wherein the solid dosage form is a tablet, pill or caplet.

32. A method of treating inflammation or inflammation associated disorders in a mammal in need of such treatment comprising the step of administering to said mammal an effective amount of a pharmaceutical composition in solid dosage form comprising potassium, sodium or Tris salt of oxaprozin as an active agent, wherein about 75% of the active agent in said solid dosage form becomes dissolved in 1,000 ml of pH 7.4 phosphate buffer media at 37.degree.C. with paddle stirring at 75 rpm within about 30 minutes.

33. The method of claim 32, wherein the active agent is from about 37.14% to about 100% by weight of the total composition.

34. The method of claim 32, wherein the solid dosage form is a tablet, pill or caplet.

35. The pharmaceutical composition of any of claims 1, 9 or 23, wherein about 95% of the active agent in said solid dosage form becomes dissolved in said phosphate buffer media within about 30 minutes.

36. The method of claim 29, wherein about 95% of the active agent in said solid dosage form becomes dissolved in said phosphate buffer media within about 30 minutes.
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