Johnson Matthey Public Limited Company

Robert S Marmor

Nicolas Archer

Barbara Jamieson

Michael Bease

David August

An improved process for preparing buprenorphine and a method for increasing the yield of buprenorphine or a derivative thereof.

Method of preparing buprenorphine

Processes for reducing the amount of impurities, especially &#x3b1;,&#x3b2;-unsaturated ketones (ABUK), in materials containing morphine. Novel compounds, namely low ABUK morphine sulfate methanolic solvate, and a novel crystal form are also described. The method for making morphine sulfate methanolic solvate comprises mixing a morphine free base composition with methanol to form a solution and adding a liquid comprising sulfuric acid to the solution to form a morphine sulfate methanolic solvate precipitate. A method of making a morphine sulfate compound comprises drying the morphine sulfate methanolic solvate in the presence of water vapor, such that methanol molecules are removed and replaced with water vapor molecules. A composition for treating pain comprises the morphine sulfate compound and at least one pharmaceutically acceptable excipient. A method for treating pain comprises administering to a patient in need thereof the composition comprising the morphine sulfate compound and at least one pharmaceutically acceptable excipient.

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Woodstown, NJ, United States of America

Robert S Marmor