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Highly loaded amorphous efavirenz composition and process for preparing the same
专利权人:
发明人:
Yunxia Bi,Mohammed Abdul Rahman,James David Lester,Thomas Durig,Randy Bull
申请号:
US13843224
公开号:
US09114170B2
申请日:
2013.03.15
申请国别(地区):
US
年份:
2015
代理人:
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.
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