Stable Combinations of Amlodipine Besylate and Benazepril Hydrochloride

Abstract

The present invention provides a pharmaceutical composition comprising benazepril and amlodipine wherein the benazepril and the amlodipine are in physical contact with one another, and methods for making the same.

1 . A pharmaceutical composition comprising:
 a) benazepril or its solvates, or a pharmaceutically acceptable salt thereof, and   b) amlodipine or its solvates, or a pharmaceutically acceptable salt thereof, wherein the benazepril and the amlodipine are in physical contact with one another, and wherein after about 3 months at about 40° C. at about 75% relative humidity, the pharmaceutical composition contains:   i) no more than 2.5% of (s,s)-diacid by weight relative to the benazepril; and/or   ii) no more than 0.3% of impurity D by weight relative to the amlodipine.   
   
   
       3 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition is encapsulated. 
   
   
       4 . The pharmaceutical composition of  claim 1 , wherein the benazepril is benazepril hydrochloride. 
   
   
       5 . The pharmaceutical composition of  claim 1 , wherein the amlodipine is amlodipine besylate. 
   
   
       6 . The pharmaceutical composition of  claim 1 , wherein the benazepril is prepared by wet granulation, and the amlodipine is prepared by dry processing.