PHARMACEUTICAL PRODUCT CONTAINING PROGESTIN, GENISTEIN, AND VITAMIN D COMPOUND

• US 20080167276A1
• Filed: 10/31/2007
• Published: 07/10/2008
• Est. Priority Date: 03/21/2000
• Status: Abandoned Application

• Current Assignee: Gustavo C. Rodriguez
• Original Assignee: Gustavo C. Rodriguez
• Inventors: Rodriguez, Gustavo C.
• Application Number:
  US11/931,751
• Publication Number:
  US 20080167276A1
• 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 31/352 condensed with carbocyclic rings, e.g. methantheline cannabinoids A61K31/658
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• 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 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 31/59 Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

A pharmaceutical product comprising multiple daily sequential dosages, said product comprising a progestin, genistein, and an estrogen, and optionally a Vitamin D compound. The estrogen is selected from the group consisting of estrone, estrone sulfate, estrone sulfate piperazine salt, estradiol and estriol, and their esters, mestranol, conjugated equine estrogen, esterified estrogens, estropipate, 17α-ethinylestradiol, esters and ethers of 17α-ethinylestradiol, 17beta-estradiol, estradiol valerate, piperazine estrone sulphate, estriol succinate, and polyestrol phosphate. Genistein is preferably at least 20 mg, and more preferably 50-80 mg. The progestin is selected from the group consisting of norgestimate in the range of 0.18-0.25 mg, levonorgestrel in the range of 0.05-0.3 mg, norgestrel in the range of 0.075-0.5 mg, norethindrone in the range of 0.5-1.0 mg, desogestrel in the range of 0.06-0.15 mg, gestodene in the range of 0.04-0.12 mg, dienogest in the range of 0.25-4.0 mg, drospirenone in the range of 0.25-4.0 mg, and medroxy-progesterone acetate in the range of 2.5-10 mg. The Vitamin D compound is preferably at a dosage of at least 400 IU.

Claims

1. A pharmaceutical product comprising multiple daily sequential dosages, said product comprising a progestin, genistein and an estrogen, said estrogen selected from the group consisting of estrone, estrone sulfate, estrone sulfate piperazine salt, estradiol and estriol, and their esters, mestranol, conjugated equine estrogen, esterified estrogens, estropipate, 17α

-ethinylestradiol, esters and ethers of 17α

-ethinylestradiol, 17beta-estradiol, estradiol valerate, piperazine estrone sulphate, estriol succinate, and polyestrol phosphate.

2. The product of claim 1 wherein said progestin is a norgestimate.

3. The product of claim 1 wherein said progestin is levonorgestrel.

4. The product of claim 1 further including at least one daily dosage including genistein at a dosage of at least 20 mg.

5. The product of claim 1 wherein said dosage of the genistein in at least one daily dosage is between 50 mg and 80 mg.

6. The composition of claim 4 wherein said estrogen compound is ethinyl estradiol in the range of 20-35 mcg.

7. The product of claim 6 wherein said progestin has multiple daily dosages and said progestin is selected from the group consisting of norgestimate in the range of 0.18-0.25 mg, levonorgestrel in the range of 0.05-0.3 mg, norgestrel in the range of 0.075-0.5 mg, norethindrone in the range of 0.5-1.0 mg, desogestrel in the range of 0.06-0.15 mg, gestodene in the range of 0.04-0.12 mg, and dienogest in the range of 0.25-4.0 mg, and drospirenone in the range of 0.25-4.0 mg, and wherein said product is contraceptively effective.

8. The product of claim 4 wherein said progestin has multiple daily dosages and said progestin is medroxy-progesterone acetate in the range of 2.5-10 mg, wherein said estrogen has multiple daily dosages and said estrogen compound is selected from the group consisting of conjugated estrogens in the range of 0.3-2.5 mg and estrified estrogens in the range of 0.625-1.25 mg, and wherein said product is for hormone replacement therapy.

9. The product of claim 1 further comprising a Vitamin D compound.

10. The product of claim 9 wherein the Vitamin D compound is selected from the group consisting of cholecalciferol, ergocalciferol, 25-hydroxyvitamin D₃, and calcitriol,

11. The product of claim 9 wherein the Vitamin D compound is at a dosage of at least 400 IU and is selected from the group consisting of cholecalciferol, ergocalciferol, and 25-hydroxyvitamin D₃.

12. A pharmaceutical product comprising multiple daily sequential dosages, said product including 21 sequential daily hormone dosages, each hormone dosage comprising a progestin and an estrogen, said estrogen selected from the group consisting of estradiol and estriol, and their esters, mestranol, 17α

-ethinylestradiol, esters and ethers of 17α

-ethinylestradiol, and 17beta-estradiol, and with at least one of said multiple daily sequential dosages including genistein at a dosage of at least 20 mg, and wherein said product is contraceptively effective.

13. The composition of claim 12 wherein said estrogen compound is ethinyl estradiol in the range of 20-35 mcg.

14. The product of claim 12 further comprising a Vitamin D compound.

15. The product of claim 14 wherein the Vitamin D compound is at a dosage of at least 400 IU and is selected from the group consisting of cholecalciferol, ergocalciferol, and 25-hydroxyvitamin D₃.

16. The product of claim 12 wherein said progestin has multiple daily dosages and said progestin is selected from the group consisting of norgestimate is the dosage range of 0.18-0.25 mg, levonorgestrel in the range of 0.05-0.3 mg, norgestrel in the range of 0.075-0.5 mg, norethindrone in the range of 0.5-1.0 mg, desogestrel in the range of 0.06-0.15 mg, gestodene in the range of 0.04-0.12 mg, and dienogest in the range of 0.25-4.0 mg, and drospirenone in the range of 0.25-4.0 mg.

17. The product of claim 16 wherein said daily dosage of the genistein is between 50 mg and 80 mg.

18. The product of claim 16 wherein said 21 sequential daily hormone dosages each include genistein at a dosage of at least 20 mg.

19. The product of claim 16 further including 25-hydroxyvitamin D₃.

20. The product of claim 16 further including cholecalciferol at a dosage between 2000 IU and 4000 IU.

22. The product of claim 20 wherein said daily dosage of the genistein is between 50 mg and 80 mg.

23. The product of claim 20 further including 25-hydroxyvitamin D₃.

24. The product of claim 20 further including cholecalciferol at a dosage between 2000 IU and 4000 IU.

25. The product of claim 12 wherein said 21 sequential daily hormone dosages each include genistein at a dosage of at least 20 mg.

21. A pharmaceutical product comprising multiple daily sequential dosages, said product including 21 sequential daily hormone dosages, each hormone dosage comprising an estrogen and optionally a progestin, said estrogen selected from said estrogen compound is selected from the group consisting of conjugated estrogens with a daily dosage in the range of 0.3-2.5 mg and estrified estrogens with a daily dosage in the range of 0.625-1.25 mg, and with at least one of said multiple daily sequential dosages including genistein at a dosage of at least 20 mg, and wherein said product is for hormone replacement therapy.