Hormone replacement composition and method

• US 7,879,830 B2
• Filed: 08/25/2005
• Issued: 02/01/2011
• Est. Priority Date: 09/02/2004
• Status: Active Grant

• Current Assignee: Teresa S. Wiley
• Original Assignee: Teresa S. Wiley
• Inventors: Wiley, Teresa S.
• Primary Examiner(s): Padmanabhan; Sreeni
• Assistant Examiner(s): JEAN-LOUIS, SAMIRA JM
• Application Number:
  US11/212,001
• Publication Number:
  US 20070049567A1
• Time in Patent Office: 1,986 Days
• Field of Search: 514/170, 514/169, 514/178, 514/182
• US Class Current: 514/170
• 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 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• 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 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00

Abstract

Hormone compositions including bioidentical hormones dispersed in a lipid-based cream are provided in syringes for dispensation and self-administration by a user. The compositions, which are topically applied by the user, are percutaneously delivered to the vascular system of the user in accordance with a dosage protocol that causes a rhythmic and cyclic variation in the serum hormone levels that mimics the temporal variation in hormone levels present in the serum of a normal premenopausal woman.

Claims

1. A method for self-administering bioidentical hormone replacement therapy for women, comprising the steps of:

(a) Presenting a first composition comprising bioidentical estradiol in a pharmacologically acceptable vehicle operable for transdermal delivery of the estradiol by topical administration of the first composition, and a second composition comprising bioidentical progesterone in a pharmacologically acceptable vehicle operable for transdermal delivery of the progesterone by topical administration of the second composition, said first and second compositions being housed in respective first and second dispensers;

then

(b) Applying said first composition to the woman'"'"'s skin twice daily over a twenty eight day period in a quantity sufficient to replicate the temporal variations in the serum concentration of said estradiol in the woman in accordance with the estradiol curve beginning at cycle day 1 of, wherein the first composition is administered to the skin in accordance with the following schedule;

4 mg estradiol twice daily on days 1-5;

6 mg estradiol twice daily on days 6-8;

7 mg estradiol twice daily on days 9-11;

8 mg estradiol twice daily on day 12;

2 mg estradiol twice daily on days 13-14;

3 mg estradiol twice daily on days 15-17; and

approximately 4 mg estradiol twice daily on days 18-28; and

(c) Applying said second composition to the woman'"'"'s skin twice daily from the luteal phase to day twenty eight in a quantity sufficient to replicate the temporal variations in the serum concentration of said progesterone in the woman in accordance with the progesterone curve beginning at cycle day 14 of, wherein the second composition is administered to the skin in accordance with the following schedule;

100 mg progesterone twice daily on days 14-15;

200 mg progesterone twice daily on days 16-17;

250 mg progesterone twice daily on days 18-19;

300 mg progesterone twice daily on day 20;

350 mg progesterone twice daily on day 21;

300 mg progesterone twice daily on day 22;

250 mg progesterone twice daily on days 23-24;

200 mg progesterone twice daily on days 25-26; and

100 mg progesterone twice daily on days 27-28.

2. The method for self-administering bioidentical hormone replacement therapy for women in accordance with claim 1 wherein said first composition comprises 1 mg estradiol in 0.1 ml vehicle.

3. The method for self-administering bioidentical hormone replacement therapy for women in accordance with claim 2 wherein said second composition comprises 25 mg progesterone in 0.1 ml vehicle.

4. A method for self-administering bioidentical hormone replacement therapy for women, comprising the steps of:

(a) presenting a first composition comprising botanical bioidentical estradiol in a pharmacologically acceptable vehicle operable for transdermal delivery of the estradiol by topical administration of the first composition, and a second composition comprising botanical bioidentical progesterone in a pharmacologically acceptable vehicle operable for transdermal delivery of the progesterone by topical administration of the second composition, said first and second compositions being housed in respective first and second dispensers;

then

(b) applying said first composition to the woman'"'"'s skin twice daily over a twenty-eight day period so as to restore a reproductive serum level in accordance with the estradiol curve beginning at cycle day 1 in a quantity sufficient to replicate the temporal variations in the serum concentration of said estradiol in the woman;

(c) applying said second composition to the woman'"'"'s skin twice daily from the luteal phase to day twenty-eight so as to restore a reproductive serum level in accordance with the progesterone curve beginning at cycle day 14 in a quantity sufficient to replicate the temporal variations in the serum concentration of said progesterone in the woman.

5. The method of claim 4, wherein the first composition is administered to the skin in accordance with the following dosing schedule:

4 mg estradiol twice daily on days 1-5;

6 mg estradiol twice daily on days 6-8;

7 mg estradiol twice daily on days 9-11;

8 mg estradiol twice daily on day 12;

2 mg estradiol twice daily on days 13-14;

3 mg estradiol twice daily on days 15-17;

4 mg estradiol twice daily on days 18-28.

6. The method of claim 5, wherein the second composition is administered to the skin in accordance with the following dosing schedule:

approximately 100 mg progesterone twice daily on days 14-15;

200 mg progesterone twice daily on days 16-17;

250 mg progesterone twice daily on days 18-19;

300 mg progesterone twice daily on day 20;

350 mg progesterone twice daily on day 21;

300 mg progesterone twice daily on day 22;

250 mg progesterone twice daily on days 23-24;

200 mg progesterone twice daily on days 25-26;

100 mg progesterone twice daily on days 27-28.