STABLE PHARMACEUTICAL COMPOSITION OF BUPRENORPHINE AND PREPARATION METHOD AND USE THEREOF
Dossier Overview
Applicant
ALAR PHARMACEUTICALS INC.
Inventor
Tong-Ho LIN; Yung-Shun WEN; Chia-Hsien CHEN
IPC Classification
CPC Classification
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.
Original (Chinese)
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.
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