KUMAR SAMARTH,SONI MAHESHKUMAR PARASMAL,VAYOSA MILAN MOHANBHAI,KANE PRASHANT,BHOWMICK SUBHAS BALARAM,THENNATI RAJAMANNAR
申请号：
IN201621007739
公开号：
IN201621007739A
申请日:
2016.03.04
申请国别(地区):
IN
年份:
2017
代理人:
摘要：
The present invention provides a parenteral dosage form consisting essentially of a solution filled in a container, the solution comprising amiodarone or its pharmaceutically acceptable salt and a sulfo-alkyl ether beta-cyclodextrin in an aqueous vehicle, wherein the solution has a pH in the range of about 2.4 to 3.9 and further wherein the dosage form is sterilized by subjecting the filled container to autoclaving. The commercially marketed products of amiodarone are prepared by sterile filtration and aseptic filling technology. However, these techniques of sterilization are inferior to terminal sterilization methods such as autoclaving which offers a higher confidence of sterility compliance. Since amidarone is very slightly soluble in water and is known to degrade significantly upon storage at higher temperatures, it is therefore difficult to prepare a stable, clear aqueous solution of amiodarone by autoclaving or terminally sterilizing the solution in an autoclave. Thus, there lies an urgent need for a parenteral dosage form of amiodarone that can be sterilized by terminal sterilization process like autoclaving and which remains stable upon autoclaving and upon long term storage. The present invention precisely fulfills this need. The present invention provides a parenteral dosage form consisting essentially of a solution filled in a container, the solution comprising amiodarone or its pharmaceutically acceptable salt and a sulfo-alkyl ether beta- cyclodextrin in an aqueous vehicle, wherein the solution has a pH in the range of about 2.4 to 3.9 and further wherein the dosage form is sterilized by subjecting the filled container to autoclaving.
