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STABLE PHARMACEUTICAL COMPOSITION OF BUPRENORPHINE AND PREPARATION METHOD AND USE THEREOF

发明专利审中
11浏览
21权利要求 · 2 独立
§ Ⅰ

卷宗概要

发明人

Tong-Ho LIN; Yung-Shun WEN; Chia-Hsien CHEN

IPC 分类

A61K 31/485A61K 9/8A61K 47/10A61K 47/18A61K 47/22

CPC 分类

A61K31/485A61K9/8A61K47/10A61K47/18A61K47/22

Provided is a pharmaceutical composition including buprenorphine, a derivative thereof, or a pharmaceutically acceptable salt thereof, a stabilizer, a biocompatible solvent, and at least one compound represented by Formula (IIA), (IIB) or (IIC), wherein Ris hydrogen, a C-Calkylcarbonyl group, or a C-Carylcarbonyl group, and wherein the compound of Formula (IIA), (IIB) and (IIC) each have an amount of less than 1% w/w based on the total weight of the pharmaceutical composition during a shelf life of the pharmaceutical composition. Also provided is a method for preparing the pharmaceutical composition and a method for treating opioid addiction, pain, and/or depression in a subject in need thereof by administering the pharmaceutical composition to the subject.

原文(中文)

Provided is a pharmaceutical composition including buprenorphine, a derivative thereof, or a pharmaceutically acceptable salt thereof, a stabilizer, a biocompatible solvent, and at least one compound represented by Formula (IIA), (IIB) or (IIC), wherein Ris hydrogen, a C-Calkylcarbonyl group, or a C-Carylcarbonyl group, and wherein the compound of Formula (IIA), (IIB) and (IIC) each have an amount of less than 1% w/w based on the total weight of the pharmaceutical composition during a shelf life of the pharmaceutical composition. Also provided is a method for preparing the pharmaceutical composition and a method for treating opioid addiction, pain, and/or depression in a subject in need thereof by administering the pharmaceutical composition to the subject.