PHARMACEUTICAL PRODUCTS CONTAINING HORMONES AND A 25-HYDROXY VITAMIN D COMPOUND

• US 20080312197A1
• Filed: 06/14/2007
• Published: 12/18/2008
• Est. Priority Date: 06/14/2007
• Status: Abandoned Application

• Current Assignee: Gustavo C. Rodriguez
• Original Assignee: Gustavo C. Rodriguez
• Inventors: Rodriguez, Gustavo C.
• Application Number:
  US11/763,250
• Publication Number:
  US 20080312197A1
• Time in Patent Office: Days
• US Class Current: 514/167
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/567 substituted in position 17 alpha, e.g. mestranol, norethandrolone
• CPC Class Codes: A61K 31/59 Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

The present invention relates to pharmaceutical products containing progestins in combination with the 25 hydroxy Vitamin D compounds. The 25 hydroxy Vitamin D compounds are preferably administered with the progestins. In OC and HRT regimens, the 25 hydroxy Vitamin D compounds can be administered daily, or on a non-daily basis, and if so, preferably when the progestin dosages are the highest in the cycle.

Claims

1. A composition comprising 25-hydroxy Vitamin D compound and a progestin, wherein the dosage of said Vitamin D compound is in the range of 2.5-40 mcg.

2. The composition of claim 1 wherein the dosage of said Vitamin D compound is at least 6.25 mcg.

3. The composition of claim 2 wherein the dosage of said Vitamin D compound is at least 12.5 mcg.

4. The composition of claim 1 wherein the dosage of said Vitamin D compound is in the range of 12.5 to 25 mcg.

5. The composition of claim 1 wherein the dosage of said Vitamin D compound is in the range of 25-40 mcg.

6. The composition of claim 1 wherein said Vitamin D compound is 25-hydroxy Vitamin D₃.

8. The composition of claim 6 wherein the dosage of said Vitamin D compound is in the range of 6.25-20 mcg.

9. The composition of claim 8 wherein the dosage of said Vitamin D compound is in the range of 12.5-20 mcg.

10. The composition of claim 1 wherein said hormone compound is an estrogen.

11. The composition of claim 10 wherein said estrogen compound is a conjugated equine estrogen.

12. The compound of claim 1 wherein said hormone compound is estradiol.

13. The composition of claim 1 wherein said hormone compound includes norgestimate.

14. The composition of claim 13 wherein said hormone compound includes 0.18-0.25 mg norgestimate.

15. The composition of claim 14 wherein said hormone compound includes 15-35 mcg ethinyl estradiol.

16. The composition of claim 1 wherein said hormone compound includes levonorgestrel and ethinyl estradiol.

17. The composition of claim 1 wherein said hormone compound includes 3.0 mg drospirenone and 20-30 mcg ethinyl estradiol.

18. The composition of claim 16 wherein said hormone compound includes 90 mcg levonorgestrel and 20 mcg ethinyl estradiol.

7. The composition of claim wherein said Vitamin D compound is 25-hydroxy Vitamin D₂.

19. A pharmaceutical combination comprising 21 daily sequential dosages, said product including 21 sequential daily hormone dosages, with at least one hormone dosage comprising a progestin product, and optionally estrogen, and wherein the remaining daily hormone dosages include estrogen, and optionally a progestin product, and with at least one of said dosages further comprising a 25-hydroxy Vitamin D compound in the range of 2.5-40 mcg.

20. The combination of claim 19 wherein the dosage of said Vitamin D compound is at least 6.25 mcg.

22. The combination of claim 19 wherein the dosage of said Vitamin D compound is in the range of 12.5 to 25 mcg.

23. The combination of claim 19 wherein the dosage of said Vitamin D compound is in the range of 25-40 mcg.

24. The combination of claim 19 wherein said Vitamin D compound is 25-hydroxy Vitamin D₃.

25. The combination of claim 19 wherein said Vitamin D compound is 25-hydroxy Vitamin D₂.

26. The combination of claim 19 wherein said estrogen product is ethinyl estradiol.

27. The combination of claim 26 wherein the daily dosage of said ethinyl estradiol is less than or equal to 0.035 mg and greater than or equal to 0.015 mg.

28. The combination of claim 19 wherein said progestin product is a gonane.

29. The combination of claim 19 wherein said progestin product is a pregnane.

30. The combination of claim 19 wherein said progestin product is a estrane.

31. The combination of claim 19 wherein said progestin product is norgestimate in the range of 0.18-0.25 mcg.

32. The combination of claim 31 wherein said the estrogen product in at least one hormone dosage is ethinyl estradiol and the daily dosage of said ethinyl estradiol is less than or equal to 0.035 mg and greater than or equal to 0.020 mg.

33. The combination of claim 19 wherein at least one Vitamin D compound is in a single unit dosage with one dosage of said progestin product.

34. The combination of claim 19 wherein at least one hormone dosage includes 3.0 mg drospirenone and 20-30 mcg ethinyl estradiol

21. The combination of claim 21 wherein the dosage of said Vitamin D compound is at least 12.5 mcg.