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    • 2. 发明申请
    • COATED PELLETS
    • 涂层
    • US20100068290A1
    • 2010-03-18
    • US12483646
    • 2009-06-12
    • Iris ZieglerIrwin Jacobs
    • Iris ZieglerIrwin Jacobs
    • A61K9/16
    • A61K9/5015A61K9/0095A61K9/5026A61K9/5036A61K9/5047Y02A50/473Y02A50/475Y02A50/481
    • Coated pellets which comprise an active pharmaceutical ingredient that is poorly soluble in water, release at least 80% of the active ingredient under in vitro conditions in phosphate buffer at pH 5.0 after 30 minutes and are bioequivalent to a liquid formulation of the active ingredient under in vitro fed status test conditions and/or are coated with a composition, which includes a lipophilic component (A) and a hydrogel former (B), wherein the pure lipophilic component (A) has (i) an HLB value of ≦5, and/or (ii) a melting range of ≧60° C, and/or (iii) a solidification range Δ of less than 35° C., and/or (iv) a density of ≧0.80 g cm−3.
    • 包含难溶于水的活性药物成分的包被的丸粒在体外条件下在30分钟后在pH 5.0的磷酸盐缓冲液中释放至少80%的活性成分,并且与活性成分的液体制剂在生物等效于在 体外饲养状态测试条件和/或涂覆有包含亲脂性组分(A)和水凝胶形成剂(B)的组合物,其中纯亲脂性组分(A)具有(i)HLB值为< 和/或(ii)熔点范围≥60℃,和/或(iii)凝固范围&Dgr; 小于35℃,和/或(iv)≧0.80g cm -3的密度。