Bristol-myers Squibb Compnay

Uday S Gogate

Shreeram N Agharkar

Vijay H Naringrekar

Lawan Phusanti

Thomas A Haby

A process for formulating certain epothilones and analogs thereof for parenteral administration is provided wherein the pH of the formulation for administration can be controlled to enhance the stability and thus, potency of the epothilone, or analog thereof.

Process and formulation containing epothilones and analogs thereof

This invention relates to a stable, easy to constitute, injectable formulation of anticancer agent BMY-25067. More specifically, the present invention concerns a formulation of BMY-25067 obtained from lyophilizing a solution comprising up to 4 mg of BMY-25067 per mL of 65% t-butanol/water, further comprising about 2% PVP (K-12 or K-17), optionally comprising pharmaceutically acceptable carrier(s).

Stable injectable formulation of BMY-25067

A stabilized pharmaceutical composition containing paclitaxel, teniposide, camptothecin or other antineoplastic agent susceptible to degradation during storage is produced using a solvent system containing a low carboxylate anion content. The solvent system is a mixture of ethanol and a polyoxyethylated castor oil. The polyoxyethylated castor oil is treated with an acid or contacted with alumina to reduce the carboxylate anion content of the solvent. The low carboxylate anion content of the solvent provides extended shelf life and lower amounts of degradation by-products.

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North Brunswick, NJ, United States of America

Uday S Gogate