Patent ID: 8445653
Filing Date: 2013-05-21
Classification: A61K,A61P,C07H

Abstract:
1. A method for producing a stabilized lyophilized preparation comprising (1) amrubicin or a salt thereof; and (ii) wherein the water content within the preparation is 0 to 3.5% by weight based on the weight of the lyophilized powder, which comprises the following Steps (1) to (5): (1) preparing an aqueous solution of (a) amrubicin or a salt thereof, and (b) L-cysteine or a salt thereof by dissolving them in water; (2) adjusting the pH value of the aqueous solution of the above (1) to pH 2 to pH 5; (3) sterilizing the aqueous solution of the above (2) by aseptic filtration; (4) lyophilizing the aqueous solution obtained in the above (3) under conditions for controlling the water content within the preparation so that the water content is in the range of 0 to 3.5% by weight based on the weight of the lyophilized powder and (5) subjecting the preparation to humidity conditions so that the water content is adjusted to a value greater than 0% and up to 3.5%.