Claims
- 1. Substantially pure pravastatin sodium.
- 2. The pravastatin sodium of claim 1 containing less than 0.5% pravastatin lactone.
- 3. The pravastatin sodium of claim 1 containing less than 0.2% epiprava.
- 4. The pravastatin sodium of claim 1 containing less than 0.5% pravastatin lactone and less than 0.2% epiprava.
- 5. The pravastatin sodium of claim 1 containing less than 0.2% pravastatin lactone.
- 6. The pravastatin sodium of claim 1 containing less than 0.1% epiprava.
- 7. The pravastatin sodium of claim 1 containing less than 0.2% pravastatin lactone and less than 0.1% epiprava.
- 8. Substantially pure pravastatin sodium prepared by a process comprising the steps of:
a) forming an organic solution of pravastatin; b) obtaining solid pravastatin as a pravastatin salt; c) purifying the pravastatin salt by recrystallization; d) transposing the cation of the pravastatin salt to pravastatin sodium; and, e) isolating pravastatin sodium substantially, free of pravastatin lactone and epiprava.
- 9. The process of claim 8, wherein the organic solution of pravastatin is an enriched organic solution of pravastatin.
- 10. The process of claim 8, wherein the cation of the pravastatin salt is an amine.
- 11. The process of claim 10, wherein the amine is selected from the group consisting of ammonium, a primary amine, a secondary amine and a tertiary amine.
- 12. The process of claim 8, wherein the cation of the pravastatin salt is an alkali metal cation.
- 13. The process of claim 12, wherein the alkali metal cation is selected from the group consisting of lithium, sodium and potassium.
- 14. The process of claim 8, wherein the solid pravastatin is in the form of a crystal.
- 15. The process of claim 8, wherein the solid pravastatin is in the form of an amorphous precipitate.
- 16. The substantially pure pravastatin sodium of claim 8 wherein the organic solution of pravastatin is formed by extracting an aqueous fermentation broth with a first organic solvent, back-extracting pravastatin with an aqueous solution at pH of about 8.0 to about 9.5, acidifying the basic aqueous solution to a pH of about 2.0 to about 3.7 and extracting the acidified aqueous solution with a second organic solvent to form an organic solution of pravastatin.
- 17. The substantially pure pravastatin sodium of claim 16 wherein the first and second organic solvents are i-butyl acetate.
- 18. The substantially pure pravastatin sodium of claim 8 wherein the ammonium salt is purified by at least one crystallization from a mixture of water and an anti-solvent.
- 19. The substantially pure pravastatin sodium of claim 18 wherein the anti-solvent is selected from the group consisting of i-butyl acetate and acetone.
- 20. The substantially pure pravastatin sodium of claim 18 wherein ammonium chloride is added to the mixture of water and anti-solvent to induce crystallization of the ammonium salt.
- 21. The substantially pure pravastatin sodium of claim 8 wherein the ammonium salt is transposed using an acidic or chelating ion exchange resin.
- 22. The substantially pure pravastatin sodium of claim 8 wherein the pravastatin sodium is isolated by recrystallization.
- 23. The substantially pure pravastatin sodium of claim 8 wherein the pravastatin sodium is isolated by lyophilization.
- 24. A formulation comprising pravastatin sodium and less than about 0.5% pravastatin lactone.
- 25. A pharmaceutical composition comprising the substantially pure pravastatin sodium of claim 1.
- 26. A pharmaceutical dosage form comprising the pharmaceutical composition of claim 25.
- 27. A pharmaceutical dosage form comprising the substantially pure pravastatin sodium of claim 1.
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application claims priority under 35 U.S.C. 119(e) to U.S. Provisional Application No. 60/238,276, filed Oct. 5, 2000, which is incorporated herein by reference.
Provisional Applications (1)
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Number |
Date |
Country |
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60238276 |
Oct 2000 |
US |