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Claims for Patent: 5,952,300

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Claims for Patent: 5,952,300

Title: Antifungal compositions
Abstract:The invention is a pharmaceutical composition for intravenous administration to a patient comprising a) a pharmaceutically effective amount of a compound having the formula ##STR1## and the pharmaceutically acceptable salts thereof; b) a pharmaceutically acceptable amount of an excipient such as a bulking agent effective to form a lyophilized cake; and c) a pharmaceutically acceptable amount of acetate buffer effective to provide a pH of between about 4 and 7.
Inventor(s): Nerurkar; Maneesh J. (Lansdale, PA), Hunke; William A. (Harleysville, PA), Kaufman; Michael J. (New Hope, PA)
Assignee: Merck & Co., Inc. (Rahway, NJ)
Application Number:08/827,510
Patent Claims: 1. A pharmaceutical composition for intravenous administration to a patient comprising

a) a pharmaceutically effective amount of a compound having the formula ##STR9## and the pharmaceutically acceptable salts thereof, b) a pharmaceutically acceptable amount of an excipient effective to form a lyophilized cake; and

c) a pharmaceutically acceptable amount of an acetate buffer effective to provide a pharmaceutically acceptable pH.

2. A pharmaceutical composition of claim 1 comprising

a) a pharmaceutically effective amount of Compound I;

b) between about 10-200 mg/ml of an excipient effective to form a lyophilized cake; and

c) a pharmaceutically acceptable amount of an acetate buffer effective to provide a pH of between about 4 and 7.

3. The composition of claim 2 comprising about 5-200 mg/ml of Compound I or a pharmaceutically acceptable salt thereof, about 12.5 mM to about 200 mM of an acetate buffer, about 10-200 mg/ml of bulking agent, and water.

4. The composition of claim 3 comprising about 30-50 mg/ml of Compound I or a pharmaceutically acceptable salt thereof, about 20-60 mM of an acetate buffer, about 30-70 mg/ml of bulking sugar or combination of bulking sugars effective to form a lyophilized cake, and water.

5. The composition of claim 4 comprising 42 mg/ml of Compound I or a pharmaceutically acceptable salt thereof, 25 mM of an acetate buffer, 30 mg/ml of sucrose, 20 mg/ml of mannitol, and water.

6. The composition of claim 4 comprising 42 mg/ml of Compound I or a pharmaceutically acceptable salt thereof, 50 mM of an acetate buffer, 30 mg/ml of sucrose, 20 mg/ml of mannitol, and water.

7. A process for making a pharmaceutical composition containing a compound having the formula ##STR10## and the pharmaceutically acceptable salts thereof, which comprises the steps of

a) dissolving a bulking agent or combination of agents in water;

b) adding acetic acid and adjusting the pH to about 3.7;

c) adding Compound I and adjusting the pH to about 5 with base;

d) filtering the solution thus prepared;

e) filling said solution into a lyophilization vial and freezing at -50.degree. C.; and

f) freeze drying the frozen solution.

8. A composition made by the process of claim 7.

9. The composition of claim 2 wherein the excipient is a bulking agent or combination of bulking agents.
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