FOREMAN, James Michael,UKEJE, Anayo Michael,SWANK, Ronald W.,WONG, Waiken
申请号：
EP16747314
公开号：
EP3253372A4
申请日:
2016.02.05
申请国别(地区):
EP
年份:
2018
代理人:
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.
