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Claims for Patent: 5,114,948

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Claims for Patent: 5,114,948

Title: Stabilized pergolide compositions
Abstract:Pharmaceutical compositions containing pergolide or a salt thereof stabilized to oxidation by incorporation therewith of a stabilizing agent selected from methionine, cysteine, and cysteine hydrochloride.
Inventor(s): Conine; James W. (Indianapolis, IN), Sparks; Denis L. (Greenwood, IN), Stowers; Julian L. (Indianapolis, IN)
Assignee: Eli Lilly and Company (Indianapolis, IN)
Application Number:07/424,018
Patent Claims: 1. A pharmaceutical composition of pergolide or a salt thereof stabilized to oxidation comprising a therapeutically effective amount of pergolide or a salt thereof, a stabilizing agent selected from methionine, cysteine, and cysteine hydrochloride in an amount sufficient to effect stabilization to oxidation, and pharmaceutically acceptable excipients.

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

3. A pharmaceutical composition of claim 2 wherein the stabilizing agent is L-methionine.

4. A pharmaceutical composition of claim 3 wherein the L-methionine is present in said composition in an amount of from 0.1 to 2 percent by weight of the total composition.

5. A pharmaceutical composition of claim 4 wherein the L-methionine is present in said composition in an amount of from 0.2 to 1.0 percent by weight of the total composition.

6. A pharmaceutical composition of claim 5 which is a tablet weighing approximately 300 mg containing approximately 73 mcg of pergolide mesylate and approximately 1 mg of L-methionine.

7. A composition of claim 1 which additionally contains a compound selected from polyvinylpyrrolidone, propyl gallate, and .alpha.-tocopherol in an amount sufficient to effect stabilization to decomposition by light.

8. A composition according to claim 7 wherein the light stability agent is polyvinylpyrrolidone.

9. A composition according to claim 8 wherein the oxidation stabilizing agent is L-methionine.

10. A composition according to claim 9 wherein pergolide is present as the mesylate salt.

11. A composition according to claim 10 which is about 0.02-0.03% pergolide mesylate, about 0.2-0.4% L-methionine, and about 1-2% polyvinylpyrrolidone.

12. A composition according to claim 11 which is a tablet weighing approximately 300 mg containing approximately 73 mcg of pergolide mesylate, approximately 1 mg of L-methionine, and approximately 4 mg of polyvinylpyrrolidone.

13. A method of stabilizing a pharmaceutical composition of pergolide or a salt thereof to decomposition by oxidation 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 methionine, cysteine and cysteine hydrochloride in an amount sufficient to effect stabilization to decomposition by oxidation.

14. The method of claim 13 wherein the pergolide is present as pergolide mesylate.

15. The method of claim 14 wherein the stabilizing agent is L-methionine.

16. The method of claim 15 wherein the L-methionine is present in an amount of from 0.1 to 2 percent by weight of the total composition.

17. The method of claim 16 wherein the L-methionine is present in an amount of from 0.2 to 1.0 percent by weight of the total composition.
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