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Summary 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)|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for patent 4,619,935|
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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