TWO-LAYERED TABLETS BASED ON ESTROGEN / SELECTIVE MODULATOR OF ESTROGEN RECEPTOR AND ESTROGEN / PROGESTIN

摘要

1. A two-layer tablet containing:! (a) a first layer containing at least one estrogen; and! (b) a second layer containing one or more therapeutic agents selected from the group comprising a selective estrogen receptor modulator and a progestational agent. ! 2. The tablet according to claim 1, characterized in that:! said first layer is from about 20 to about 45% by weight of said tablet; and! said second layer is from about 55 to about 80% by weight of said tablet. ! 3. The tablet according to claim 1 or 2, characterized in that said estrogen comprises conjugated estrogens. ! 4. A tablet according to any one of claims 1 or 2, characterized in that said second layer contains one or more therapeutic agents selected from the group consisting of medroxyprogesterone acetate and 1- [4- (2-azepan-1-yl-ethoxy) -benzyl] -2- (4-hydroxy-phenyl) -3-methyl-1H-indol-5-ol or a pharmaceutically acceptable salt of these compounds. ! 5. The tablet according to claim 4, characterized in that said therapeutic agent is 1- [4- (2-azepan-1-yl-ethoxy) benzyl] -2- (4-hydroxy-phenyl) -3-methyl- 1H-indol-5-ol acetate. ! 6. A tablet according to any one of claims 1, 2 or 5, characterized in that each said first layer and said second layer further independently comprise a hydrophilic gelling polymer component. ! 7. The tablet according to claim 6, characterized in that each of the hydrophilic gel-forming polymer component in the first layer and the hydrophilic gel-forming polymer component in the second layer independently includes one or more substances selected from their hydroxypropyl methylcellulose, polyethylene oxide, hydroxypropyl cellulose, hydroxyethyl cellulose, methyl