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

A pharmaceutical product comprising a dosage unit of a pharmaceutical composition comprising micronized progesterone, soy bean lecithin, and sunflower oil, wherein at least 80% of the particles of said micronized progesterone is characterized by a particle size of between 1 and 15 μm, as measured in the composition. wherein the dosage unit comprises between 2 mg and 600 mg of micronized progesterone.

A method for preparing a pharmaceutical composition comprising micronized progesterone, soy bean lecithin, and sunflower oil, wherein at least 80% of the particles of said micronized progesterone is characterized by a particle size of between 1 and 15 μm, as measured in the composition, comprising the following successive steps:

• mixing (A) sunflower oil with (B) soy bean lecithin with stirring, in order to obtain a mixture;
• and
• adding the micronized progesterone, with stirring, to said mixture to obtain a homogeneous suspension.

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 comprising micronized progesterone, soy bean lecithin, and sunflower oil, wherein at least 80% of the particles of said micronized progesterone is characterized by a particle size of between 1 and 15 μm, as measured in the composition.