Stabilized atorvastatin
AssigneeLife Cycle Pharma
InventorPer Holm
Life of this patent
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Abstract
A stable pharmaceutical composition for oral administration comprising atorvastatin and an amount of a pharmaceutically acceptable organic alkalizing compound capable of establishing a microenvironment for atorvastatin having a pH of at least about 5, for example 2-amino-2-(hydroxymethyl)-1,3-propanediol (trometamol).
Claims15
A stable pharmaceutical composition for oral administration comprising atorvastatin or a pharmaceutically acceptable salt thereof and an amount of a pharmaceutically acceptable organic alkalizing compound capable of establishing a micro-environment for atorvastatin having a pH of at least about 5.
A tablet comprising atorvastatin or a pharmaceutically acceptable salt thereof, less than 0.5% w/w of tromethamine and less than 0.2% w/w of atorvastatin lactone after 6 months storage at 25° C. at 60% relative humidity.
A method for preparing a tablet comprising atorvastatin and an amount of a pharmaceutically acceptable organic alkalizing compound capable of establishing a microenvironment for atorvastatin having a pH of at least about 5, which method comprises the steps of:
- i) preparing a solid pharmaceutical composition by wet granulation of atorvastatin and the alkalizing compound, and
- iii) compressing the composition into a tablet.
Dependencies are inferred from the claim text.