发明名称 |
Solid Pharmaceutical Compositions for Treating HCV |
摘要 |
The present invention features solid pharmaceutical compositions comprising Compound 1 and Compound 2. In one embodiment, the solid pharmaceutical composition includes (1) a first layer which comprises 100 mg Compound 1, as well as a pharmaceutically acceptable hydrophilic polymer and a pharmaceutically acceptable surfactant, all of which are formulated in amorphous solid dispersion; and (2) a second layer which comprises 40 mg Compound 2, as well as a pharmaceutically acceptable hydrophilic polymer and a pharmaceutically acceptable surfactant, all of which are formulated in amorphous solid dispersion. |
申请公布号 |
US2016375087(A1) |
申请公布日期 |
2016.12.29 |
申请号 |
US201615192211 |
申请日期 |
2016.06.24 |
申请人 |
AbbVie Inc. |
发明人 |
Sever Nancy E.;Westedt Ulrich;Lander Ute;Schneider Katrin;Steitz Benedikt;Mueller Thomas;Reul Regina;Obermiller Constanze;Jayasankar Adivaraha;Simon Michael;Gao Yi;Hach Harald;Kyeremateng Samuel;Asmus Katharina;Tong Ping;Zhu Donghua;Naris Marius;Garrett Colleen |
分类号 |
A61K38/06;A61K9/28;A61K9/20;A61K9/16;A61K31/4184;A61K9/24 |
主分类号 |
A61K38/06 |
代理机构 |
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代理人 |
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主权项 |
1. A solid pharmaceutical composition comprising:
(1) 100 mg Compoundformulated in amorphous solid dispersion which further comprises from 50% to 80% by weight of a first pharmaceutically acceptable polymer and from 5% to 15% by weight of a first pharmaceutically acceptable surfactant; and
(2) 40 mg Compound 2formulated in amorphous solid dispersion which further comprises from 50% to 80% by weight of a second pharmaceutically acceptable polymer and from 5% to 15% by weight of a second pharmaceutically acceptable surfactant,
wherein the composition has the following in vitro release profile: when the composition is dissolved in 1000 mL of a dissolution medium using a standard USP dissolution Apparatus 2 (paddle) with Japanese sinker operating at 75 RPM at 37° C., at least 80% of Compound 1 in the composition is released within 3 hours and at least 80% of Compound 2 in the composition is released within 3 hours, wherein the dissolution medium is 0.1 M Acetate buffer (pH 4.0) with 1% Polysorbate 80. |
地址 |
North Chicago IL US |