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Last Updated: March 29, 2024

Details for Patent: 9,855,224


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Title:Method for enhancing the bioavailability 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 (FI)
Filing Date:Dec 16, 2015
Application Number:14/971,252
Claims:1. A method for treating one or more vaginal symptoms of urogenital atrophy due to menopause with ospemifene, the improvement comprising increasing ospemifene absorption by about 2-3 fold by orally administering the ospemifene in connection with the intake of a meal, wherein the increase is as compared to the administration of ospemifene in a fasted state.

2. The method of claim 1, wherein the meal comprises a high-fat, high-calorie meal.

3. The method of claim 1, wherein the meal comprises a low-fat, low-calorie meal.

4. The method of claim 1, wherein peak ospemifene mean serum concentration is reached in about 2-3 hours after administration.

5. The method of claim 4, wherein the increase in peak mean serum concentration is between 1 and 4 times greater as compared to said administration in a fasted state.

6. The method of claim 1, wherein the improvement further comprises instructing a patient that ospemifene should be taken with food.

7. A method for treating one or more vaginal symptoms of urogenital atrophy due to menopause, comprising increasing the peak mean serum concentration of ospemifene by orally administering ospemifene in connection with a meal, wherein the increase in peak mean serum concentration of ospemifene is as compared to the administration in a fasted state.

8. The method of claim 7, wherein the increase is between 1 and 4 times greater.

9. The method of claim 7, wherein the meal comprises a high-fat, high-calorie meal.

10. The method of claim 7, wherein the meal comprises a low-fat, low-calorie meal.

11. The method of claim 7, wherein the peak ospemifene mean serum concentration is reached in about 2-3 hours after administration.

12. The method of claim 11, wherein ospemifene absorption increases by about 2-3 fold.

13. The method of claim 7, further comprising instructing a patient that ospemifene should be taken with food.

14. A method of treating one or more vaginal symptoms of urogenital atrophy due to menopause, comprising orally administering a therapeutically effective amount of ospemifene in connection with a meal wherein the absorption of ospemifene is increased by about 2-3 fold, wherein the increase is as compared to the administration of ospemifene in a fasted state.

15. The method of claim 14, wherein the meal comprises a high-fat, high-calorie meal.

16. The method of claim 14, wherein the meal comprises a low-fat, low-calorie meal.

17. The method of claim 14, wherein the peak ospemifene mean serum concentration is reached in about 2-3 hours after administration.

18. The method of claim 17, wherein the increase in peak mean serum concentration is about 1-4 times greater.

19. The method of claim 14, further comprising instructing a patient that ospemifene should be taken with food.

20. A method for enhancing the absorption of orally administered ospemifene for the treatment of one or more symptoms of menopause, comprising administering said ospemifene in connection with the intake of a meal, thereby increasing the absorption of ospemifene by about 2-3 fold, wherein the increase is as compared to the administration of ospemifene in a fasted state.

21. The method of claim 20, wherein the meal comprises a high-fat, high-calorie meal.

22. The method of claim 20, wherein the meal comprises a low-fat, low-calorie meal.

23. The method of claim 20, wherein the peak ospemifene mean serum concentration is reached in about 2-3 hours after administration.

24. The method of claim 23, wherein the increase in peak mean serum concentration is about 1-4 times greater.

25. The method of claim 20, further comprising instructing a patient that ospemifene should be taken with food.

26. A method for increasing the bioavailability of orally administered ospemifene, comprising orally administering ospemifene in connection with a meal, thereby increasing the peak mean serum concentration of ospemifene as compared to administration in a fasted state.

27. The method of claim 26, wherein the increase is between 1 and 4 times greater.

28. The method of claim 26, wherein the meal comprises a high-fat, high-calorie meal.

29. The method of claim 26, wherein the meal comprises a low-fat, low-calorie meal.

30. The method of claim 26, wherein the peak mean serum concentration is reached in about 2-3 hours after administration.

31. The method of claim 30, wherein ospemifene absorption increases by about 2-3 fold.

32. The method of claim 26, further comprising instructing a patient that ospemifene should be taken with food.

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