Parenteral formulation for epothilone analogs

A process for formulating an epothilone analog having the formula:

• and/or a pharmaceutically-acceptable salt, geometric, optical, or stereoisomer thereof, comprising:
• a) dissolving said epothilone analog in a mixture of tertiary butanol and water to form a solution, wherein the mixture comprises at least about 50% by volume tertiary butanol;
• b) performing primary drying of said solution at a temperature, chamber pressure and period of time sufficient to form a primary lyophilized product;
• and
• c) performing secondary drying of the primary lyophilized product at a temperature, chamber pressure and for a period of time sufficient to form a lyophilized product of the epothilone analog.

A process for formulating an epothilone analog represented by formula II:

• and/or a pharmaceutically-acceptable salt, geometric, optical, or stereoisomer thereof, comprising:
• a) dissolving said epothilone analog to form a solution, comprising first, wetting said epothilone analog with a mixture of at least about 60% by volume tertiary-butanol in water, and then adding sufficient water, or a mixture of tertiary-butanol and water, so that the resulting solution contains at least about 50% by volume tertiary-butanol in water, wherein said step of dissolving is carried out at a temperature below ambient temperature;
• b) performing primary drying of said solution at a temperature, chamber pressure and for a period of time sufficient to form a primary lyophilized product;
• and
• c) performing secondary drying of the primary lyophilized product at temperature, chamber pressure and for a period of time sufficient to form a lyophilized product of the epothilone analog.