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Claims for Patent: 6,495,165

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Claims for Patent: 6,495,165

Title: Eplerenone compositions having improved bioavailability
Abstract:The invention relates to oral pharmaceutical compositions useful as aldosterone receptor blockers comprising the active agent micronized eplerenone in an amount of about 10 mg to about 1000 mg and one or more carrier materials.
Inventor(s): Thosar; Shilpa S. (Des Plaines, IL), Gokhale; Rajeev D. (Waukegan, IL), Tolbert; Dwain S. (Wadsworth, IL)
Assignee: G.D. Searle & Co. (Skokie, IL)
Application Number:10/101,361
Patent Claims: 1. A pharmaceutical composition comprising particulate eplerenone and one or more pharmaceutically acceptable carrier materials; wherein said composition, upon oral administration in an eplerenone dosage amount of about 100 mg to a fasted adult human subject, exhibits an eplerenone pharmacokinetic profile having at least one of (a) C.sub.max not less than about 1500 ng/ml; (b) T.sub.max not greater than about 1.8 hours; (c) AUC.sub.0-96 not less than about 7900 (ng/ml)hr and (d) plasma concentration one hour after administration not less than about 1225 ng/ml; said dosage amount being administered in one to a plurality of dosage unit forms.

2. The composition of claim 1 that exhibits an eplerenone pharmacokinetic profile having C.sub.max not less than about 1500 ng/ml.

3. The composition of claim 1 that exhibits an eplerenone pharmacokinetic profile having T.sub.max not greater than about 1.8 hours.

4. The composition of claim 1 that exhibits an eplerenone pharmacokinetic profile having AUC.sub.0-96 not less than about 7900 (ng/ml)hr.

5. The composition of claim 1 that exhibits an eplerenone pharmacokinetic profile having plasma concentration one hour after administration not less than about 1225 ng/ml.

6. The composition of claim 1 that exhibits an eplerenone pharmacokinetic profile having all of (a) C.sub.max not less than about 1500 ng/ml; (b) T.sub.max not greater than about 1.8 hours; (c) AUC.sub.0-96 not less than about 7900 (ng/ml)hr and (d) plasma concentration one hour after administration not less than about 1225 ng/ml.

7. A pharmaceutical composition comprising particulate eplerenone and one or more pharmaceutically acceptable carrier materials; wherein said composition, upon oral administration at an eplerenone dosage amount of about 100 mg to a fasted adult human subject, exhibits C.sub.max and/or AUC.sub.0-96 at least substantially similar to that exhibited by an orally administered solution of eplerenone; said dosage amount being administered in one to a plurality of dosage unit forms.

8. The composition of any of claims 1 to 7 wherein the dosage unit forms contain about 25 to about 100 mg eplerenone.

9. The composition of any of claims 1 to 7 wherein the dosage unit forms contain about 25, about 50 or about 100 mg eplerenone.

10. A method of treating a condition or disorder where treatment with an aldosterone receptor blocker is indicated, comprising orally administering a composition of claim 1 to a patient in need of such treatment.

11. The method of claim 10 where the condition or disorder is heart failure.

12. The method of claim 10 where the condition or disorder is hypertension.

13. The method of claim 10 where the condition or disorder is edema associated with liver insufficiency.

14. The method of claim 10 where the condition or disorder is post-myocardial infarction.

15. A method of treating a condition or disorder where treatment with an aldosterone receptor blocker is indicated, comprising orally administering a composition of claim 7 to a patient in need of such treatment.

16. The method of claim 15 where the condition or disorder is heart failure.

17. The method of claim 15 where the condition or disorder is hypertension.

18. The method of claim 15 where the condition or disorder is edema associated with liver insufficiency.

19. The method of claim 15 where the condition or disorder is post-myocardial infarction.

20. The composition of any of claims 1 to 7 wherein the dosage unit forms contain about 50 mg eplerenone.

21. The composition of any of claims 1 to 7 wherein the dosage unit forms contain about 100 mg eplerenone.
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