发明名称 |
Highly loaded amorphous efavirenz composition and process for preparing the same |
摘要 |
A stable and high loading ternary solid dispersion composition comprising (a) about 50% wt. to about 90% wt. of amorphous Efavirenz; (b) about 10% wt. to about 50% wt. of polyvinyl pyrrolidone (PVP), a first polymer; (c) about 1% wt. to about 30% wt. of a water-soluble second polymer; and (d) optionally about 0.1% wt. to about 50% wt. of at least one pharmaceutically acceptable excipient. Also discloses a high loading ternary composition comprising (a) a solid dispersion composition comprising (i) about 50% wt. to about 90% wt. of amorphous Efavirenz; (ii) about 10% wt. to about 50% wt. of polyvinyl pyrrolidone, a first polymer; (b) about 1% wt. to about 30% wt. of a water-soluble second polymer blended with solid dispersion of composition of (a); and (c) optionally about 0.1% wt. to about 50% wt. of at least one pharmaceutically acceptable excipient. Additionally discloses a method for preparing solid dosage forms comprising (i) amorphous Efavirenz and (ii) polyvinyl pyrrolidone (PVP), a first polymer; (iii) a water-soluble second polymer; and (iv) optionally, at least one pharmaceutical excipients. |
申请公布号 |
US9114170(B2) |
申请公布日期 |
2015.08.25 |
申请号 |
US201313843224 |
申请日期 |
2013.03.15 |
申请人 |
ISP INVESTMENTS INC. |
发明人 |
Bi Yunxia;Rahman Mohammed Abdul;Lester James David;Durig Thomas;Bull Randy |
分类号 |
A61K31/536;C07D265/14;A61K47/38;A61K47/32;B29C43/00;A61K9/14;A61K9/16 |
主分类号 |
A61K31/536 |
代理机构 |
|
代理人 |
Davis William J. |
主权项 |
1. A stable and high loading ternary solid dispersion composition comprising:
a. about 50% wt. to about 90% wt. of amorphous Efavirenz; b. about 10% wt. to about 50% wt. of polyvinyl pyrrolidone, a first polymer; c. about 1% wt. to about 30% wt. of a water-soluble second polymer; and d. optionally about 0.1% wt. to about 50% wt. of at least one pharmaceutically acceptable excipient. |
地址 |
Wilmington DE US |