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Claims for Patent: 4,619,935

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Claims for Patent: 4,619,935

Title: Stable oncolytic formulations
Abstract:Stable, sterile, ready-to-use formulations of oncolytic vincristine are provided.
Inventor(s): Robison; Robert L. (Greenwood, IN)
Assignee: Eli Lilly and Company (Indianapolis, IN)
Application Number:06/659,389
Patent Claims: 1. A formulation comprising a stable, sterile, ready-to-use solution suitable for i.v. injection containing about 1-2 mg./ml. of a salt of vincristine, about 10-100 mg./ml. of a polyol selected from the group consisting of mannitol, sorbitol, and sucrose, an acetate buffer in the range of about 0.02-0.0005M to maintain the pH of the solution between 3.0 and 5.0, about 1-2 mg./ml. of a preservative selected from the group consisting of methyl paraben and propyl paraben, singly or in combination, and water.

2. A formulation according to claim 1 substantially free of chloride ion.

3. A formulation according to claim 1 in which the polyol is mannitol.

4. A formulation according to claim 1 in which the concentration of the acetate buffer is 0.01-0.002M.

5. A formulation according to claim 1 containing per ml. of final solution about 1 mg. of vincristine sulfate, 10-100 mg. of mannitol, 1-2 mg. of a preservative selected from the group consisting of methyl paraben and propyl paraben, singly or in combination, and water q.s. to 1 ml., with the pH of said solution being maintained by a 0.02-0.0005M acetate buffer.

6. A formulation according to claim 5 in which the buffered pH range is 4.4-4.8.

7. A formulation according to claim 6 in which the concentration of the acetate buffer is 0.01-0.002M.

8. A formulation according to claim 7 which contains, per ml. of final solution, about 1 mg. of vincristine sulfate, 100 mg. of mannitol, 1.3 mg. of methyl paraben, and 0.2 mg. of propyl paraben.
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