Pharmaceutical composition containing esomeprazole
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- CTC BIO INC
- Publication Date
- 2010-08-18
- Estimated Expiration
- Not applicable · inactive patent
Smart Images
Figure 1 
Figure 2 
Figure 3
Abstract
Description
technical field
[0001] The present invention relates to pharmaceutical formulations containing esomeprazole free base or basic salts of esomeprazole, which pharmaceutical formulations have improved stability. Background technique
[0002] Esomeprazole ((S)-5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridyl)methylsulfinyl]-3H-benzo Imidazole) is a proton pump inhibitor used in the treatment of gastric ulcer, gastroesophageal reflux and the like. The free base of esomeprazole is not ideal in terms of storage stability and physical properties. Specifically, esomeprazole free base has a melting point of about 45°C, making it difficult to prepare; moreover, its stability is so poor that after two months of storage at 25°C / 60% RH, its total The impurity content increased to around 1%. In addition, esomeprazole is less stable under alkaline conditions than under acidic or neutral conditions.
[0003] Commercially available products utilize esomeprazole magnesium salt to enhance the...