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Claims for Patent: 4,797,405

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Claims for Patent: 4,797,405

Title: Stabilized pergolide compositions
Abstract:Pharmaceutical compositions containing pergolide or a salt thereof stabilized to decomposition by light by incorporation therewith of a stabilizing agent selected from polyvinylpyrrolidone, .alpha.-tocopherol succinate and propyl gallate.
Inventor(s): Conine; James W. (Indianapolis, IN), Stowers; Julian L. (Indianapolis, IN)
Assignee: Eli Lilly and Company (Indianapolis, IN)
Application Number:07/112,360
Patent Claims: 1. A pharmaceutical composition of pergolide or a salt thereof stabilized to decomposition by light comprising a therapeutically effective amount of pergolide or a salt thereof, a stabilizing agent selected from polyvinylpyrrolidone, .alpha.-tocopherol succinate and propyl gallate in an amount sufficient to effect stabilization to decomposition by light and pharmaceutically acceptable excipients.

2. The pharmaceutical composition of claim 1 wherein the pergolide is present as pergolide mesylate.

3. The pharmaceutical composition of claim 2 wherein the stabilizing agent is polyvinylpyrrolidone.

4. The pharmaceutical composition of claim 3 wherein the polyvinylpyrrolidone is present in said composition in an amount of from 0.3 to 2 percent by weight of the total composition.

5. The pharmaceutical composition of claim 4 wherein the polyvinylpyrrolidone is present in said composition in an amount of from 0.5 to 1.5 percent by weight of the total composition.

6. A method of stabilizing a pharmaceutical composition of pergolide or a salt thereof to decomposition by light comprising incorporating into said pharmaceutical composition, in addition to a therapeutically effective amount of said pergolide or a salt thereof and pharmaceutically acceptable excipients, a stabilizing agent selected from polyvinylpyrrolidone, .alpha.-tocopherol succinate and propyl gallate in an amount sufficient to effect stabilization to decomposition by light.

7. The method of claim 6 wherein the pergolide is present as pergolide mesylate.

8. The method of claim 7 wherein the stabilizing agentis polyvinylpyrrolidone.

9. The method of claim 8 wherein the polyvinylpyrrolidone is present in an amount of from 0.3 to 2 percent by weight of the total composition.

10. The method of claim 9 wherein the polyvinylpyrrolidone is present in an amount of from 0.5 to 1.5 percent by weight of the total composition.
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