发明名称 |
PREPARATION OF AN OIL-IN-WATER EMULSION FOR POLYMER STABILIZED PHARMACEUTICAL FORMULATIONS |
摘要 |
An improved process for producing an oil-in-water emulsion to deliver a substantially water insoluble active pharmaceutical ingredient includes creating a microemulsion containing such ingredient in the oil phase of the emulsion by mixing an aqueous phase including non-ionic surfactant, polyol, and water, wherein the weight ratio of the surfactant to polyol to water is between 10:20:70 and 1:1:1, to generate a mixture, with an oil phase comprising a substantially water insoluble active pharmaceutical ingredient and a long-chain triglyceride; circulating the said mixture through a homogenizer at a temperature from 20 °C to 60 °C to generate a coarse emulsion; passing the coarse emulsion through a microfluidizer at a pressure of from 70 MPa to 150 MPa at least once to produce an oil-in-water microemulsion; and, optionally, filtering the microemulsion through a 0.2 µm filter and/or mixing the microemulsion with a polymeric stabilizer. |
申请公布号 |
WO2016127022(A1) |
申请公布日期 |
2016.08.11 |
申请号 |
WO2016US16703 |
申请日期 |
2016.02.05 |
申请人 |
FOREMAN, JAMES MICHAEL;UKEJE, ANAYO MICHAEL;SWANK, RONALD W.;WONG, WAIKEN |
发明人 |
FOREMAN, JAMES MICHAEL;UKEJE, ANAYO MICHAEL;SWANK, RONALD W.;WONG, WAIKEN |
分类号 |
A61K9/107;A61K31/337;A61K31/436;A61K38/13;A61K38/22;A61K47/10;A61K47/30;A61K47/44 |
主分类号 |
A61K9/107 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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