# US 5,703,111 A · Stable injectable formulation of BMY-25067

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- Number: US 5,703,111 A
- Document ID: US5703111A
- Status: Granted
- Kind: A
- Application number: 08/760,237
- Filed: 1996-12-04
- Granted: 1997-12-30
- Earliest claimed: 1996-12-04
- Assignees: Bristol-Myers Squibb Company
- Inventors: Uday S. Gogate; Shreeram N. Agharkar; Lawan Phusanti
- Web page: https://patentgrep.com/patent/US5703111A

## CPC

- A61K 31/403: condensed with carbocyclic rings, e.g. carbazole
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## 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).

## Claims

### Claim 1

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.

### Claim 2 (depends on 1)

A pharmaceutical formulation of BMY-25067 as claimed in claim 1 obtained from a solution containing 4 mg of BMY-25067 per mL of 65% t-butanol/water, further containing about 2% PVP (K-12 or K-17), optionally containing one or more pharmaceutically acceptable carriers.

### Claim 3 (depends on 1, 2)

A pharmaceutical formulation as claimed in claim 1 or 2 which comprises 1.5% mannitol as a pharmaceutically acceptable carrier.

### Claim 4

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).

### Claim 5 (depends on 4)

A method of obtaining a pharmaceutical formulation of BMY-25067 as claimed in claim 4 comprising the steps of: (a) freezing the solution comprising 4 mg of BMY-25067 per mL of 65% t-butanol/water, further comprising about 2% PVP (K-12 or K-17), and 1.5% mannitol as a pharmaceutically acceptable carrier, 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).