Stabilized and lyophilized formulation of anthracycline compounds
AssigneeDainippon Sumitomo Pharma Co., Ltd.
InventorsHajimu Hirofuji, Hotaka Hashimoto, Kazunari Tanaka
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Abstract
The present invention provides a lyophilized amrubicin formulation and a process thereof. In the process, the concentration of the aqueous solution before lyophilization is controlled to about 7.5 mg(potency)/mL or more. Thus, the formulation decreases the production of desaccharified compound and is stable to storage for a long period. The formulation is useful as a cancer chemotherapeutic agent.
Claims9
A process for preparing a lyophilized amrubicin formulation comprising the following Steps (1) to (3):
- (1) preparing an aqueous solution comprising (a) amrubicin or a pharmaceutically acceptable salt thereof and (b) L-cysteine or a salt thereof wherein the concentration of amrubicin or a pharmaceutically acceptable salt thereof is in the range of 7.5 mg(potency)/mL to 30 mg(potency)/HmL,
- (2) sterilizing the aqueous solution of Step (1) by filtration, and
- (3) lyophilizing the aqueous solution obtained in Step (2).
A lyophilized formulation comprising amrubicin or a pharmaceutically acceptable salt thereof which is prepared by lyophilizing an aqueous solution comprising amrubicin or a pharmaceutically acceptable salt thereof in the range of 7.5 mg potency)/mL to 30 mg(potency)/mL, and wherein the lyophilized formulation further comprises L-cysteine or a salt thereof.
Dependencies are inferred from the claim text.