KUMAR SAMARTH,THAKKAR MILAN NATVARBHAI,DAVE KANDARP MAHESHKUMAR
申请号：
IN4533/MUM/2015
公开号：
IN2015MU04533A
申请日:
2015.12.01
申请国别(地区):
IN
年份:
2017
代理人:
摘要：
The present invention relates to a parenteral dosage form comprising a) a ready-to-infuse, stable aqueous solution comprising diltiazem or its pharmaceutically acceptable salt, pH adjusting agent to provide a pH in the range of 3 to 5 and ethanol, and b) an infusion container filled with said aqueous solution. The problem in the art is that diltiazem is susceptible to hydrolysis and degradation in aqueous solutions. The degradation is undesirable as it results in loss of titer of the active ingredient, and leads to formation of impurities or related compounds which have negligible activity and are undesirable. Further, the commercially available products of diltiazem are pre-concentrate solutions which need to be diluted before use. The step of dilution and handling involves risk of potential calculation or dilution error as well as risk of microbiological contamination during handling. The present invention addresses these problems and provides a stable parenteral dosage form of diltiazem, which comprise an aqueous solution of diltiazem that is ready-to-infuse without manipulation and at the same time is stable for prolonged period of time.
