KUMAR SAMARTH,KANE PRASHANT,BHOWMICK SUBHAS BALARAM,THAKKAR MILAN NATVARBHAI,DAVE KANDARP MAHESHKUMAR
申请号：
IN201621030175
公开号：
IN201621030175A
申请日:
2016.09.02
申请国别(地区):
IN
年份:
2018
代理人:
摘要：
The present invention relates to a stable infusion dosage form of morphine or its pharmaceutically acceptable salt which is stable upon autoclaving and has long term stability. There is a need in the art for a stable infusion dosage form of morphine which is terminally sterilized and can withstand the harsh conditions of autoclaving and show long term storage stability such that the content of known, unknown and total impurities does not increase upon autoclaving and the levels are maintained within the desired limit upon long term storage at room temperature. The present invention fulfills this need. The present invention provides a stable infusion dosage form of morphine or its pharmaceutically acceptable salt which is stable upon autoclaving and has long term stability. Particularly, the present invention provides an infusion dosage form comprising (i) an aqueous solution of morphine or its pharmaceutically acceptable salt as a sole active ingredient in a concentration ranging from about 0.1 mg/ml to about 10.0 mg/ml, filled in containers in volumes ranging from about 50 ml to about 250 ml, and having dissolved oxygen content of less than 2 ppm, (ii) the container being surrounded by an outer covering, and (iii) an inert gas or vacuum is present in the space between the container and outer covering, wherein the infusion dosage form is sterilized by autoclaving and is stable upon autoclaving, and further wherein the space between the container and outer covering does not have an oxygen scavenger pouch before or during autoclaving.
