Stable injectable formulation of BMY-25067
AssigneeBristol-Myers Squibb Company
InventorsUday S. Gogate, Shreeram N. Agharkar, Lawan Phusanti
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Abstract
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).
Claims5
A pharmaceutical 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 one or more pharmaceutically acceptable carriers.
A method of obtaining a pharmaceutical formulation of BMY-25067 comprising the steps of:
- (a) freezing the 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), and optionally comprising one or more pharmaceutically acceptable carriers, at -40.degree. C. for 5 hours under a vacuum of 250 microns;
- (b) followed by primary drying at shelf temperature of -20.degree. C. for 36 hours;
- (c) followed by secondary drying at 25.degree. C. for 48 hours;
- while vacuum was maintained at 100-250 micron by bleeding nitrogen gas throughout the drying processes of steps (b) and (c).
Dependencies are inferred from the claim text.