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US 5,690,962 AGranted
Stable solid formulation of enalapril salt and process for preparation thereof
AssigneeApotex Inc.
InventorBernard Charles Sherman
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Abstract
There is disclosed a stable pharmaceutical solid composition comprising enalapril as the sodium salt, which is made by the steps of: i) mixing enalapril maleate with a carrier, an alkaline sodium compound, and water ii) drying the wet mass, and; iii) further processing the resultant dried mass into tablets. When the water is added in the aforesaid process, an acid-base reaction occurs which converts the enalapril maleate into the more stable enalapril sodium salt.
Claims8
A process of manufacture of a pharmaceutical solid composition comprising enalapril sodium, which process comprises the steps of:
- i)
- a) mixing enalapril maleate with an alkaline sodium compound and at least one other excipient, adding water sufficient to moisten, and mixing to achieve a wet mass, or
- b) mixing enalapril maleate with at least one excipient other than an alkaline sodium compound, adding a solution of an alkaline sodium compound in water, sufficient to moisten and mixing to achieve a wet mass;
- thereby to achieve a reaction without converting the enalapril maleate to a clear solution of enalapril sodium and maleic acid in water.
- ii) drying the wet mass, and
- iii) further processing the dried material into a pharmaceutical solid composition.
3 more elements
Dependencies are inferred from the claim text.