ORAL SOLID INSTANT-RELEASE DOSAGE FORMS COMPRISING FINASTERIDE AND AN ANIONIC SURFACTANT-METHODS OF MANUFACTURING THEREOF

摘要

A method of preparation of an oral solid dosage form with instant release of an active agent containing as the active agent finasteride characterized in that that an aqueous suspension containing 5 % to 50 % by weight of finasteride, based on the total weight of the suspension, and 0.1% to 50 % byweight of at least one anion surfactant, based on the weight of finasteride is milled in order to reach such distribution of particle size of finasteride that the size of 10 % of particles does not exceed 2 µm, the size of 50 % of particles does not exceed 7 µm, and the size of 90 % of particles does not exceed 17 µm, then the obtained aqueous suspension is sprayed to a fluid bed onto a solid particle hydrophilic carrier having such distribution of particle size that the size of 90 % of particles exceeds 40 µm and the size of 10 of particles exceeds 200 µm, and the size of 99 % of particles does not exceed 300 µm.