Forms of pravastatin sodium
AssigneeTeva Gyogyszergyar Reszvenytarsasag
InventorsVilmos Keri, Csaba Szabo, Edit Nagyne Arvai, Judith Aronhime
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Abstract
New polymorphic forms of pravastatin sodium are provided. Each of the new forms is selectively obtained by crystallization from different solvent systems, each solvent system having a protic component, and by controlling the rate of crystallization through temperature. The new polymorphic forms are suitable for use as active substances of pharmaceutical dosage forms for reduction of serum cholesterol levels in the bloodstream.
Claims168
Crystalline pravastatin sodium and hydrates thereof having an X-ray powder diffraction pattern comprising characteristic peaks at 3.9, 4.5, 6.2, 7.2, and 20.0±0.2 degrees measured at reflection angle 2θ.
Crystalline pravastatin sodium and hydrates thereof having an X-ray powder diffraction pattern comprising characteristic peaks at 3.6, 6.1 and 6.6 ±0.2 degrees measured at reflection angle 2θ.
Crystalline pravastatin sodium and hydrates thereof having an X-ray powder diffraction pattern comprising characteristic peaks at 13.0, 15.5, 16.0 and 21.0±0.2 degrees measured at reflection angle 2θ.
Crystalline pravastatin sodium and hydrates thereof having an X-ray powder diffraction pattern comprising characteristic peaks at 6.3 and 9.8±0.2 degrees measured at reflection angle 2θ.
Crystalline pravastatin sodium and hydrates thereof having an X-ray powder diffraction pattern comprising characteristic peaks at 4.6, 10.3, 12.1, and 16.6±0.2 degrees measured at reflection angle 2θ.
Crystalline pravastatin sodium and hydrates thereof having an X-ray powder diffraction pattern comprising characteristic peaks at 3.5, 5.9, 9.0, 10.1 and 17.0±0.2 degrees measured at reflection angle 2θ.
Crystalline pravastatin sodium and hydrates thereof having an X-ray powder diffraction pattern comprising characteristic peaks at 3.5, 5.9, 8.9, 10.1, 17.6, 18.8 and 20.8±0.2 degrees measured at reflection angle 2θ.
Crystalline pravastatin sodium and hydrates thereof having an X-ray powder diffraction pattern comprising characteristic peaks at 4.4, 5.2, 5.8, 6.5, 13.2, and 14.0±0.2 degrees measured at reflection angle 2θ.
Crystalline pravastatin sodium and hydrates thereof having an X-ray powder diffraction pattern comprising characteristic peaks at 3.8, 6.0, and 16.3±0.2 degrees measured at reflection angle 2θ.
Crystalline pravastatin sodium and hydrates thereof having an X-ray powder diffraction pattern comprising characteristic peaks at 16.6, 17.6, and 18.5±0.2 degrees measured at reflection angle 2θ.
A process for preparing pravastatin sodium Form A comprising the steps of:
- (a) dissolving any solid form of pravastatin sodium in a protic solvent to form a solution;
- (b) diluting the solution of pravastatin sodium with an aprotic solvent;
- and
- (c) crystallizing the pravastatin sodium Form A from the solution of pravastatin sodium.
A process for preparing pravastatin sodium Form B comprising the steps of:
- (a) dissolving any solid form of pravastatin sodium in a protic solvent to form a solution;
- (b) diluting the solution of pravastatin sodium with an aprotic solvent;
- and
- (c) crystallizing the pravastatin sodium Form B from the solution of pravastatin sodium.
A process for preparing pravastatin sodium Form C comprising the steps of:
- (a) dissolving a solid form of pravastatin sodium in a protic solvent to form a solution;
- (b) diluting the solution of pravastatin sodium with an aprotic solvent;
- and
- (c) crystallizing the pravastatin sodium Form C from the solution of pravastatin sodium.
A process for preparing pravastatin sodium Form D comprising the steps of:
- (a) dissolving any solid form of pravastatin sodium in a protic solvent to form a solution;
- (b) diluting the solution of pravastatin sodium with an aprotic solvent;
- and
- (c) crystallizing the pravastatin sodium Form D from the solution of pravastatin sodium.
A process for preparing pravastatin sodium Form E comprising the steps of:
- (a) dissolving any solid form of pravastatin sodium in a protic solvent to form a solution;
- (b) diluting the solution of pravastatin sodium with an aprotic solvent;
- and
- (c) crystallizing the Form E pravastatin sodium from the solution of pravastatin sodium.
A process for preparing pravastatin sodium Form F comprising the steps of:
- (a) dissolving any solid form of pravastatin sodium in a protic solvent to form a solution;
- (b) diluting the solution of pravastatin sodium with an aprotic solvent;
- and
- (c) crystallizing the pravastatin sodium Form F from the solution of pravastatin sodium.
A process for preparing pravastatin sodium Form L comprising the steps of:
- (a) dissolving any solid form of pravastatin sodium in a protic solvent to form a solution;
- (b) diluting the solution of pravastatin sodium with an aprotic solvent;
- and
- (c) crystallizing the pravastatin sodium Form L from the solution of pravastatin sodium.
A process for preparing pravastatin sodium Form D comprising the steps of:
- (a) dissolving any solid form of pravastatin sodium in a protic solvent to form a solution;
- (b) diluting the solution of pravastatin sodium with an aprotic solvent;
- (c) crystallizing the pravastatin sodium Form L from the solution of pravastatin sodium;
- and
- (d) drying pravastatin sodium Form L to produce Form D.
Pravastatin sodium Form A.
Pravastatin sodium Form B.
Pravastatin sodium Form C.
Pravastatin sodium Form D.
Pravastatin sodium Form E.
Pravastatin sodium Form H.
Pravastatin sodium Form H1.
Pravastatin sodium Form I.
Pravastatin sodium Form J.
Pravastatin sodium Form L.
Dependencies are inferred from the claim text.