Pharmaceutical composition based on micronized progesterone, method for the preparation thereof and uses thereof

• US 20030092691A1
• Filed: 03/14/2002
• Published: 05/15/2003
• Est. Priority Date: 11/13/2001
• Status: Abandoned Application

• Current Assignee: Besins International Belgique
• Original Assignee: Besins International Belgique
• Inventors: Besse, Jerome, Besins, Antoine
• Application Number:
  US10/097,526
• Publication Number:
  US 20030092691A1
• Time in Patent Office: Days
• US Class Current: 514/177
• 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 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 31/685 one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
• CPC Class Codes: A61K 36/28 Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
• CPC Class Codes: A61K 36/63 Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
• 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 15/06 Antiabortive agents; Labour repressants
• CPC Class Codes: A61P 15/12 for climacteric disorders
• CPC Class Codes: A61P 5/00 Drugs for disorders of the endocrine system
• CPC Class Codes: A61P 5/24 of the sex hormones
• CPC Class Codes: A61P 5/30 Oestrogens
• CPC Class Codes: A61P 5/32 Antioestrogens
• CPC Class Codes: A61P 5/34 Gestagens

Abstract

The present invention relates to a pharmaceutical composition comprising micronized progesterone, sunflower oil and/or olive oil, and soya bean lecithin, to the method for the preparation thereof and to the uses thereof for treating a physiological condition linked to insufficiency of progesterone secretion.

Claims

1. Pharmaceutical composition comprising micronized progesterone, sunflower oil and/or olive oil, and soya bean lecithin.

2. Pharmaceutical composition according to claim 1, in which the progesterone/oil(s) ratio is between 0.15/1 and 3/1, preferably between 0.25/1 and 2/1, preferentially between 0.40/1 and 1/1, and even more preferentially is 0.67/1.

3. Pharmaceutical composition according to claim 1, in which the soya bean lecithin/oil(s) ratio is between 0.005/1 and 0.3/1, preferably between 0.01/1 and 0.2/1, preferentially between 0.040/1 and 0.1/1, and even more preferentially is 0.067/1.

4. Pharmaceutical composition according to claim 1, comprising an oestrogen, preferably selected from the group consisting of 17-β

-oestradiol, oestrone, 17-α

-ethinyl oestradiol and oestradiol valerianate, and even more preferentially is 17-β

-oestradiol.

5. Pharmaceutical composition according to claim 1, in the form of a soft capsule, of a hard capsule or of a tablet.

6. Pharmaceutical product according to claim 1, in which each dosage unit comprises between 2 mg and 600 mg of micronized progesterone, preferably between 30 mg and 300 mg, and even more preferentially between 100 mg and 200 mg.

7. Method for preparing a pharmaceutical composition according to claim 1, comprising the following successive steps:

mixing of sunflower and/or olive oil and of soya bean lecithin is carried out, with stirring, in order to obtain a mixture;

the micronized progesterone is added, with stirring, to the mixture thus obtained in order to obtain a homogeneous suspension.

8. Method of treatment of a physiological condition linked to insufficiency of progesterone secretion, comprising the step of administering a pharmaceutical composition according to claim 1 to the subject.

9. Method of treatment according to claim 8, in which the pharmaceutical composition also contains an oestrogen, preferably selected from the group consisting of 17-β

-oestradiol, oestrone, 17-α

-ethinyl oestradiol and oestradiol valerianate, and even more preferentially is 17-β

-oestradiol.