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Claims for Patent: 8,236,861

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Claims for Patent: 8,236,861

Title:Method for enhancing the bioavailablity of ospemifene
Abstract: This invention relates to a method for enhancing the bioavailability of a therapeutically active compound of the formula (I) ##STR00001## or a geometric isomer, a stereoisomer, a pharmaceutically acceptable salt, an ester thereof or a metabolite thereof, wherein said compound is administered orally to the individual in connection with the intake of food.
Inventor(s): Anttila; Markku (Turku, FI)
Assignee: Hormos Medical Corporation (Turku, FI)
Application Number:10/777,211
Patent Claims: 1. A method for enhancing the bioavailability of orally administered ospemifene or a pharmaceutically acceptable salt thereof, comprising orally administering the ospemifene or pharmaceutically acceptable salt thereof, to an individual in connection with the intake of a foodstuff having nutritional value and causing secretion of bile acids, wherein said ospemifene or pharmaceutically acceptable salt thereof is administered at a time point which is in the range defined by 1 hour before starting the food intake and 2 hours after starting the food intake to enhance bioavailability of the ospemifene or pharmaceutically acceptable salt thereof.

2. The method according to claim 1 wherein the ospemifene or pharmaceutically acceptable salt thereof is administered within one hour after the food intake was started.

3. The method according to claim 2 wherein the ospemifene or pharmaceutically acceptable salt thereof is administered at a time point which is no later than 0.5 hour after starting the food intake.

4. The method according to claim 1 wherein the ospemifene or pharmaceutically acceptable salt thereof is used for treatment of osteoporosis and the individual is in need of treatment for osteoporosis.

5. The method according to claim 4, wherein the ospemifene or pharmaceutically acceptable salt thereof is administered in oral dosage form and wherein the dosage amount is from 30 to 90 mg/day.

6. The method according to claim 5, wherein the dosage amount is 60 mg.

7. The method according to claim 1 wherein the ospemifene or pharmaceutically acceptable salt thereof is used for treatment of symptoms related to skin atrophy, or to epithelial or mucosal atrophy and the compound is administered to a patient in need of treatment of symptoms related to skin atrophy, or to epithelial or mucosal atrophy.

8. The method according to claim 7 wherein the symptoms related to atrophy are urinary symptoms or vaginal symptoms.

9. The method according to claim 7, wherein the ospemifene, or pharmaceutically acceptable salt thereof, is administered in oral dosage form and wherein the dosage amount is from 30 to 90 mg/day.

10. The method according to claim 9, wherein the dosage amount is 60 mg.

11. A method for enhancing the bioavailability of orally administered ospemifene comprising orally administering the ospemifene to an individual in connection with the intake of a foodstuff having nutritional value and causing secretion of bile acids, wherein said ospemifene is administered at a time point which is in the range defined by 1 hour before starting the food intake and 2 hours after starting the food intake to enhance bioavailability of the ospemifene.

12. The method according to claim 11, wherein the ospemifene is used for treatment of symptoms related to skin atrophy, or to epithelial or mucosal atrophy and the ospemifene is administered to an individual in need of treatment of symptoms related to skin atrophy, or to epithelial or mucosal atrophy.

13. The method according to claim 12, wherein the ospemifene is administered in oral dosage form and wherein the dosage amount is from 30 to 90 mg/day.

14. The method according to claim 13, wherein the dosage amount is 60 mg.

15. The method according to claim 11, wherein the compound is used for treatment of osteoporosis and the ospemifene is administered to an individual in need of treatment for osteoporosis.

16. The method according to claim 15, wherein the ospemifene is administered in oral dosage form and wherein the dosage amount is from 30 to 90 mg/day.

17. The method according to claim 16, wherein the dosage amount is 60 mg.

18. A method of inhibiting urogenital atrophy comprising orally administering a therapeutically effective amount of ospemifene or a pharmaceutically acceptable salt thereof to a patient in need thereof in connection with the intake of a foodstuff having nutritional value and causing secretion of bile acids, wherein said ospemifene or pharmaceutically acceptable salt thereof is administered at a time point which is in the range defined by 1 hour before starting the food intake and 2 hours after starting the food intake to enhance bioavailability of the ospemifene or pharmaceutically acceptable salt thereof.

19. The method according to claim 18 wherein the ospemifene or pharmaceutically acceptable salt thereof is administered in oral dosage form and wherein the dosage amount is from 30 to 90 mg/day.

20. The method according to claim 19 wherein the dosage amount is 60 mg.
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