Tablets containing synthesized progesterone and estradiol with a disintegration time below 15 minutes - for treatment of post-menopausal symptoms

摘要

Compositions in tablet form containing synthesized progesterone (I) having the same chemical formula as natural progesterone, and estradiol (II) such that the disintegration time of the tablet is less than 15 minutes, preferably less than 10 minutes, and especially less than 5 minutes. The disintegration time is measured by test 'D' in which a tablet is suspended in distilled water (700 ml) at 37 deg C and submitted to alternating vertical movement. The weight ratio of (II):(I) is preferably between 5:100 and 1:100. The amount of excipients present (diluents, disintegrating agents, lubricants, binders and coating) is less than 20 % of the weight of the total tablet, preferably below 17 %, especially below 15 %. The tablets preferably dissolve so that at least 75 % of both (I) and (II) is in solution within 15 minutes, especially within 5 minutes. The tablets have a hardness of 10 - 80 N, preferably 20-70 N, especially 30 - 60 N.