Dietary phytoestrogen in estrogen replacement therapy

• US 5,516,528 A
• Filed: 01/13/1995
• Issued: 05/14/1996
• Est. Priority Date: 01/13/1995
• Status: Expired due to Fees

• Current Assignee: Protein Technologies International, Inc. (Corteva, Inc.), Wake Forest University Health Sciences
• Original Assignee: Protein Technologies International, Inc. (Corteva, Inc.), Wake Forest University
• Inventors: Hughes, Claude L., Henley, Edna C., Clarkson, Thomas B.
• Primary Examiner(s): AZPURU, CARLOS A
• Application Number:
  US08/372,750
• Time in Patent Office: 487 Days
• Field of Search: 424/449, 424/451, 424/464, 424/195.1, 424/423, 514/182
• US Class Current: 424/464
• 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 31/35 having six-membered rings with one oxygen as the only ring hetero atom
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol

Abstract

Disclosed is a pharmaceutical composition for oral delivery. The composition includes about 1-2 mg mammalian estrogen and about 25-100 mg phytoestrogen. Compositions of the type described above are utilized, for example, in a therapeutic regimen designed to reduce the risk of coronary heart disease and osteoporosis in postmenopausal women. This method comprises the oral administration of a composition comprising a mixture of estrogen and phytoestrogen, the dosages of mammalian estrogen and phytoestrogen being about 1-2 mg, about 25-100 mg, respectively.

Claims

1. A pharmaceutical composition for oral delivery comprising a combination of mammalian estrogen and soy-derived phytoestrogen in an amount sufficient to reduce the risk of coronary heart disease and osteoporosis in women.

2. The pharmaceutical composition of claim 1, wherein the amount sufficient to reduce the risk of coronary heart disease and osteoporosis in women is about 1-2 mg of mammalian estrogen combined with about 25-100 mg phytoestrogen.

3. A pharmaceutical composition of claim 1 which is in pill or capsule form.

4. A pharmaceutical composition of claim 1 wherein the soy-derived mammalian estrogen is estradiol.

5. A pharmaceutical composition of claim 1 wherein the phytoestrogen is an isoflavone.

6. A pharmaceutical composition of claim 5 wherein the isoflavone is genistein.

7. A pharmaceutical composition of claim 5 wherein the isoflavone is daidzein.

8. A method for reducing the risk of coronary heart disease and osteoporosis in women, the method comprising administering orally a combination of mammalian estrogen and soy-derived phytoestrogen in a therapeutically effective amount.

9. The method of claim 8 wherein the therapeutically effective amount is a daily dosage of mammalian estrogen of about 1-2 mg, and soy-derived phytoestrogen of about 25-100 mg.

10. A method of claim 8 wherein the mammalian estrogen is estradiol.

11. A method of claim 8 wherein the soy-derived phytoestrogen is an isoflavone.

12. A method of claim 11 wherein the isoflavone is genistein.

13. A method of claim 11 wherein the isoflavone is daidzein.

14. An estrogen replacement therapy regimen, comprising the oral coadministration of a combination of mammalian estrogen and soy-derived phytoestrogen in a therapeutically effective amount.

15. The estrogen replacement therapy regimen of claim 14 wherein the therapeutically effective amount is a daily dosage of mammalian estrogen of about 1-2 mg, and soy-derived phytoestrogen of about 25-100 mg.

16. A method of claim 14 wherein the mammalian estrogen is estradiol.

17. A method of claim 14 wherein the soy-derived phytoestrogen is an isoflavone.

18. A method of claim 17 wherein the isoflavone is genistein.

19. A method of claim 17 wherein the isoflavone is daidzein.