Stabilized statin formulations
AssigneeCumberland Pharmaceuticals Inc.
InventorsLeo Pavliv, Andrew Vila
Life of this patent
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Abstract
The present invention is directed to statin formulations having improved solubility and/or stability and methods for the same.
Claims27
A liquid pharmaceutical formulation comprising an effective amount of a pharmaceutically acceptable water insoluble statin complexed with a sufficient amount of a pharmaceutically acceptable complexing agent in an aqueous solution having a pH of from about 7 to about 9 to provide a solubilized statin concentration of at least about 3.32 mg/ml.
Lyophilized particles comprising a pharmaceutically acceptable water insoluble statin and a sufficient amount of a pharmaceutically acceptable complexing agent to render the statin water-soluble when the lyophilized particles are reconstituted in a pharmaceutically acceptable solution for injection.
A method of preparing lyophilized particles comprising a pharmaceutically acceptable statin and a pharmaceutically acceptable complexing agent comprising:
- (a) adding a water insoluble statin to a mixture of the complexing agent and a suitable solvent;
- (b) mixing;
- (c) adjusting the pH using a pharmaceutically acceptable buffer to a pH range of between about 7 and about 9.
- (c) lyophilizing the mixture to obtain lyophilized particles.
A method of treatment comprising:
- (a) preparing lyophilized particles by adding a water insoluble statin to a mixture of a complexing agent and a suitable solvent and lyophilizing the mixture to obtain lyophilized particles;
- (b) reconstituting the lyophilized particles in a pharmaceutically acceptable solution for injection;
- and
- (c) administering a suitable quantity of the solution to provide an effective amount of statin to a human patient in need of treatment.
Dependencies are inferred from the claim text.