Eluvastatin sodium crystal forms, processes for preparing them, compositions containing them and methods of using them
AssigneeTeva Pharmaceutical Industries Ltd.
InventorsRevital Lifshitz-Liron, Tamas Koltai, Judith Aronhime, Nurit Perlman, Sharon Avhar-Maydan
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Abstract
Provided are polymorphic forms of fluvastatin sodium and processes for their preparation.
Claims10
A crystalline form of fluvastatin sodium characterized by a PXRD pattern with peaks at 3.7, 11.3, 13.1, 17.9, 18.4 and 21.8±0.2 degrees two-theta.
A process for preparing crystalline fluvastatin sodium Form I comprising:
- a) contacting a lower alkyl ester of fluvastatin and sodium in a solvent selected from the group consisting of acetone and acetonitrile,
- b) precipitating fluvastatin sodium Form I from the solvent, and
- c) separating the solvent from Form I.
A process for preparing crystalline fluvastatin sodium Form I comprising:
- a) dissolving fluvastatin sodium in a solvent selected from acetone and mixtures of butan-2-ol and water,
- b) crystallizing Form I from the solvent, and
- c) separating the solvent from Form I.
A crystalline form of fluvastatin sodium characterized by a PXRD pattern with peaks at 3.6±0.2 degrees two-theta.
A process for preparing crystalline fluvastatin sodium Form II comprising:
- a) dissolving solid fluvastatin sodium in a solvent selected from butan-1-ol and propan-2-ol,
- b) crystallizing Form II from the solvent, and
- c) separating the solvent from Form II.
Dependencies are inferred from the claim text.