unit dose galenische to local hormone therapy of vaginal dryness

摘要

PCT No. PCT/FR96/01555 Sec. 371 Date Jun. 5, 1998 Sec. 102(e) Date Jun. 5, 1998 PCT Filed Oct. 4, 1996 PCT Pub. No. WO97/12600 PCT Pub. Date Apr. 10, 1997A galenical formulation is intended for local, essentially non systemic, treatment of vaginal dryness, in particular in the menopausal woman. It comprises a free natural estrogen, in particular a micronized or vectorized estrogen, selected from 17 beta -estradiol and its salts in solution or in suspension in a lipophilic agent, with an estrogen content which corresponds to an equivalent unit dose of at most 15 mu g, preferably less than 10 mu g, of 17 beta -estradiol, a hydrophilic gel-forming bioadhesive agent, a gelling agent for the lipophilic agent and a hydrodispersible agent. The soft capsule form comprises a hard or soft outer envelope containing gelatin and glycerine and a non aqueous liquid or semi-liquid inner phase containing the lipophilic agent with the estrogen in solution or in suspension, the bioadhesive agent and the hydrophilic gelling agent for the lipophilic agent. The slow release vaginal suppository comprises a non aqueous hard or semi-soft solid homogeneous phase containing the lipophilic agent with the estrogen in solution or in suspension, the hydrophilic bioadhesive gel-forming agent, the gelling agent for the lipophilic agent and the hydrodispersible agent.