PHARMACEUTICAL COMPOSITION BASED ON MICRONIZED PROGESTERONE AND USES THEREOF

• US 20100330168A1
• Filed: 06/28/2010
• Published: 12/30/2010
• Est. Priority Date: 06/29/2009
• Status: Abandoned Application

• Current Assignee: Effik SA (Switzerland) (Effik SA)
• Original Assignee: Effik SA
• Inventors: Terracol, Didier, Gicquel, Jennifer, Samoyeau, Roland
• Application Number:
  US12/824,489
• Publication Number:
  US 20100330168A1
• Time in Patent Office: Days
• US Class Current: 424/451
• 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 9/4858 Organic compounds
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 5/24 of the sex hormones
• CPC Class Codes: A61P 5/30 Oestrogens
• CPC Class Codes: A61P 5/34 Gestagens

Abstract

Novel pharmaceutical compositions contain micronized progesterone and at least one oleic safflower oil referred to as safflower oil type II, and medicines comprising said compositions are useful in treating progesterone insufficiency in women.

Claims

1. A pharmaceutical composition comprising micronized progesterone and safflower oil type II.

2. A composition according to claim 1 wherein the progesterone/oil weight ratio is between about 0.15/1 and about 3/1.

3. A composition according to claim 1 wherein the progesterone/oil weight ratio is between about 0.25/1 and about 2/1.

4. A composition according to claim 1 wherein the progesterone/oil weight ratio is between about 0.40/1 and about 1/1.

5. A composition according to claim 1 wherein the progesterone/oil weight ratio is about 0.67/1.

6. A composition according to claim 1, wherein the progesterone is in suspension in the oil.

7. A composition according to claim 1, further comprising an oestrogen or an ester-type derivative thereof.

8. A composition according to claim 7 wherein the derivative is selected from the group consisting of 17β

-oestradiol, oestrone, 17α

-ethinyloestradiol, oestradiol valerate or phyto-oestrogens.

9. A composition according to claim 8 wherein the derivative is 17β

-oestradiol.

10. A composition according to claim 1, further comprising a suspending agent.

11. A composition according to claim 10, wherein the suspending agent is fumed silica.

12. A composition according to claim 1, wherein said composition is in the form of a soft capsule.

13. A pharmaceutical product comprising a composition according to claim 1, wherein said product is in the form of a dosage unit in the range of between about 2 mg and about 600 mg of micronized progesterone.

14. A product according to claim 13 wherein said dosage unit is between about 100 mg and about 400 mg.

19. A method according to claim 14 or 20 wherein the medicine additionally contains a suspending agent.

20. A method according to claim 19 wherein the suspending agent is fumed silica.

15. A method of treating a physiological condition related to progesterone secretion insufficiency, comprising administering an effective amount of a medicine comprising micronized progesterone in safflower oil type II.

16. A method according to claim 15 wherein the medicine additionally contains an oestrogen or ester-type derivative thereof.

17. A method according to claim 15 wherein the oestrogen or ester-type derivative thereof is selected from the group consisting of 17β

-oestradiol, oestrone, 17α

-ethinyloestradiol, oestradiol valerate or phyto-oestrogens.

18. A method according to claim 17 wherein the oestrogen or ester-type derivative thereof is 17β

-oestradiol.