US2011135719A1PendingUtilityA1

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

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Assignee: BESINS MFG BELGIUMPriority: Nov 13, 2001Filed: Nov 1, 2010Published: Jun 9, 2011
Est. expiryNov 13, 2021(expired)· nominal 20-yr term from priority
Inventors:Antoine BesinsJerome Besse
A61P 5/32A61P 5/30A61P 5/24A61P 5/34A61P 5/00A61P 15/00A61P 15/12A61P 15/06A61K 36/63A61K 31/57A61K 9/4858A61K 36/28A61K 31/685A61K 47/00A61K 9/48
51
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Claims

Abstract

The present invention relates to a pharmaceutical composition comprising micronized progesterone, soya bean lecithin, and at least one oil selected from the group consisting of sunflower oil, olive oil, sesame see oil, colza oil, almond oil, to the method for the preparation thereof and to the uses thereof for treating a physiological condition linked to insufficiency of progesterone secretion.

Claims

exact text as granted — not AI-modified
1 - 10 . (canceled) 
     
     
         11 . A pharmaceutical composition comprising micronized progesterone, soy bean lecithin, and at least one oil selected from the group consisting of sesame oil, colza oil, and almond oil. 
     
     
         12 . The pharmaceutical composition of  claim 11 , wherein the oil is sesame oil. 
     
     
         13 . The pharmaceutical composition of  claim 11 , wherein the oil is colza oil. 
     
     
         14 . The pharmaceutical composition of  claim 11 , wherein the oil is almond oil. 
     
     
         15 . The pharmaceutical composition of  claim 11 , wherein at least about 80% of the particles of said micronized progesterone are characterized by a particle size of between 1 and 15 μm, as measured in the composition. 
     
     
         16 . The pharmaceutical composition according to  claim 11 , wherein at least 50% of the particles of said micronized progesterone have a particle size of between 1 and 10 μm, as measured in the composition. 
     
     
         17 . The pharmaceutical composition according to  claim 11 , wherein at least 25% of the particles of said micronized progesterone have a particle size of between 1 and 5 μm, as measured in the composition. 
     
     
         18 . The pharmaceutical composition according to  claim 11 , wherein the progesterone/oil ratio is between 0.15/1 and 3/1. 
     
     
         19 . The pharmaceutical composition according to  claim 11 , wherein the soy bean lecithin/oil ratio is between 0.005/1 and 0.3/1. 
     
     
         20 . The pharmaceutical composition according to  claim 11 , wherein the progesterone/oil ratio is between 0.25/1 and 2/1. 
     
     
         21 . The pharmaceutical composition according to  claim 11 , wherein the progesterone/oil ratio is between 0.40/1 and 1/1. 
     
     
         22 . The pharmaceutical composition according to  claim 11 , wherein the progesterone/oil ratio is 0.67/1. 
     
     
         23 . The pharmaceutical composition according to  claim 11 , wherein the soy bean lecithin/oil ratio is between 0.01/1 and 0.2/1. 
     
     
         24 . The pharmaceutical composition according to  claim 11 , wherein the soy bean lecithin/oil ratio is between 0.040/1 and 0.1/1. 
     
     
         25 . The pharmaceutical composition according to  claim 11 , wherein the soy bean lecithin/oil ratio is 0.0067/1. 
     
     
         26 . The pharmaceutical composition according to  claim 11 , further comprising an estrogen or an ester-type derivative thereof. 
     
     
         27 . The pharmaceutical composition according to  claim 26 , wherein the estrogen, or the ester-type derivative thereof is selected from the group consisting of 17-beta-estradiol, estrone, 17-alpha-ethinyl estradiol and estradiol valerianate, or phyto-estrogens. 
     
     
         28 . The pharmaceutical composition according to  claim 26 , wherein the estrogen, or the ester-type derivative thereof is 17-beta-estradiol. 
     
     
         29 . The pharmaceutical composition according to  claim 11 , wherein at least the progesterone is in suspension in the oil. 
     
     
         30 . The pharmaceutical composition according to  claim 11 , in the form of a soft capsule. 
     
     
         31 . The pharmaceutical composition according to  claim 11 , in unit dosage form comprising between 2 mg and 600 mg of micronized progesterone. 
     
     
         32 . The pharmaceutical composition according to  claim 31 , comprising between 30 mg and 300 mg of micronized progesterone. 
     
     
         33 . The pharmaceutical composition according to  claim 31 , comprising between 100 mg and 200 mg of micronized progesterone. 
     
     
         34 . A method for preparing a pharmaceutical composition according to  claim 11 , comprising:
 mixing at least one oil selected from the group consisting of sesame oil, colza oil, and almond oil with soy bean lecithin in order to obtain a mixture; and   adding micronized progesterone to said mixture to obtain a homogeneous suspension.   
     
     
         35 . A method for the treatment of a physiological condition linked to insufficiency of progesterone secretion comprising the step of administering to the patient a pharmaceutical composition according to  claim 11 .

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