Therapeutic vaginal emollient

• US 20110086825A1
• Filed: 10/13/2009
• Published: 04/14/2011
• Est. Priority Date: 10/13/2009
• Status: Abandoned Application

• Current Assignee: Sylvia S. Chatroux
• Original Assignee: Sylvia S. Chatroux
• Inventors: Chatroux, Sylvia S.
• Application Number:
  US12/587,755
• Publication Number:
  US 20110086825A1
• Time in Patent Office: Days
• 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 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/568 substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone

Abstract

A topical composition for relief from certain menopausal, peri- and post-menopausal symptoms is disclosed, consisting of a low dosage of progesterone, testosterone and estriol in a pharmaceutically acceptable topical carrier in a weight ratio of from about 1:0.1:0.01 to about 1:0.1:0.02, respectively. In a preferred single dose, the three active ingredients are present as follows: (a) from about 20 to about 35 mg progesterone; (b) from about 2 to about 3.5 mg testosterone; and (c) from about 0.2 to about 0.7 mg estriol. A preferred carrier is cocoa butter, and a preferred single dose form is a vaginal suppository.

Claims

1. A composition consisting essentially of the components progesterone, testosterone and estriol in a pharmaceutically acceptable topical carrier in the weight ratio of progesterone:

testosterone;

estriol of from 1;

0.1;

0.01 to 1;

0.1;

0.02.

2. The composition of claim 1 in a single dose wherein said components are present in the following amounts:

(a) from about 20 to about 35 mg progesterone;

(b) from about 2 to about 3.5 mg testosterone; and

(c) from about 0.2 to about 0.7 mg estriol.

3. The composition of claim 2 wherein said components are present in the following weights:

(a) about 20 mg progesterone;

(b) about 3 mg testosterone; and

(c) about 0.3 mg estriol.

4. The composition of claim 1 wherein said carrier is selected from the group consisting of cocoa butter, polyethylene glycols, sorbitan fatty acid esters, polyoxyethylene fatty acid esters, polyoxyethylene stearates, aloe vera gel, aloe vera cream, petroleum jelly, glycerin, lanolin, vegetable oils and vitamin E.

5. The composition of claim 4 wherein said carrier has a melting point of from about 25 to about 35°

C.

6. The composition of claim 4 wherein said carrier is liquid at about 20°

C.

7. The composition of claim 2 wherein said carrier is cocoa butter.

8. The composition of claim 7 wherein said cocoa butter is present in said composition from about 100 to about 300 mg.

9. The composition of claim 8 in the form of a vaginal suppository.

10. A method of administering a therapeutic dose of progesterone, testosterone and estriol to a human female comprising administering the composition of claim 1 into the vaginal vault.

11. A method of administering a therapeutic dose of progesterone, testosterone and estriol to a human female comprising administering the composition of claim 2 into the vaginal vault.

12. The method of claim 11 wherein the form of said composition is a vaginal suppository.

13. The method of claim 12 wherein said carrier of said composition is cocoa butter.

14. The method of claim 13 wherein said cocoa butter is present in an amount from about 100 to about 300 mg.