KUMAR SAMARTH,KANE PRASHANT,BHOWMICK SUBHAS BALARAM,THAKKAR MILAN NATVARBHAI,DAVE KANDARP MAHESHKUMAR
申请号：
IN2346/MUM/2015
公开号：
IN2015MU02346A
申请日:
2015.06.19
申请国别(地区):
IN
年份:
2017
代理人:
摘要：
The present invention belongs to the pharmaceutical field and relates to a sterile, injectable, ready-to-administer solution of fentanyl or a salt thereof whose utility lies in treating patients in need of therapy with fentanyl or a salt thereof, such as patients suffering from pain, patients undergoing a surgical procedure etc., and who also suffer from one or more conditions that are aggravated by increased plasma concentration of sodium ions, such as hypertension, hypernatremia, heart ailments such as congenital heart diseases, renal insufficiency, critical illness. The currently available injectable products of fentanyl in the market contain sodium chloride, and these products, when intended for intravenous infusion, require dilution before administration using a suitable diluent, such as normal saline, due to which there remains a high chance of administration of large amount of sodium ions to these patients. The present invention overcomes the drawback in the art and provides a technical advancement to the existing knowledge. The present invention provides a sterile, ready-to-administer solution consisting essentially of fentanyl or a salt thereof as the sole active ingredient, a sugar or sugar alcohol and water for injection, said solution being a ready-to-administer solution, free of sodium ions, and thus being suitable in treating patients who are in need of therapy with fentanyl or a salt thereof and who are also suffering from a condition which is aggravated by an increased plasma concentration of sodium ions.
