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

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.

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.