Stable formulations of ACE inhibitors, and methods for preparation thereof
OwnerSpiridon Spireasinventor
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Abstract
The present invention provides stable formulations of ACE inhibitors, especially enalapril maleate, that can be manufactured in a time efficient, cost effective manner. Such formulations can be prepared simply and on a large industrial scale. The present invention also provides methods for the preparation of stable formulations of ACE inhibitors, especially enalapril maleate.
Claims78
A method of preparing a stable formulation of ACE inhibitor which comprises the steps of:
- mixing an ACE inhibitor with an alcohol to form an alcoholic dispersion;
- mixing a metal compound into said alcoholic dispersion;
- and
- mixing said alcoholic dispersion and said metal compound.
A method of preparing a stable formulation of an ACE inhibitor which inhibitor is susceptible to degradation comprising the steps of:
- mixing an ACE inhibitor with an alcohol to form an alcoholic dispersion;
- mixing a metal compound into said alcoholic dispersion;
- and
- mixing said alcoholic dispersion and said metal compound until a clear solution is attained.
A pharmaceutical preparation comprising a pharmaceutically acceptable stabilized ACE inhibitor substantially free of breakdown products.
A stabilized ACE inhibitor which contains less than 5% breakdown products by weight of said ACE inhibitor after incubation at 60° C. with 75% relative humidity for 10 days.
A method of preparing a stable formulation of quinapril hydrochloride which comprises the steps of:
- dispersing or dissolving a metal compound in an alcohol to form a metallic alcoholic dispersion;
- mixing quinapril hydrochloride into said metallic alcoholic dispersion;
- and
- mixing until a clear solution is attained.
A pharmaceutical preparation comprising a pharmaceutically acceptable quinapril sodium substantially free of breakdown products, wherein said breakdown products comprise quinaprilat and quinapril-DKP.
Dependencies are inferred from the claim text.