Foreman, James Michael,Ukeje, Anayo Michael,Swank, Ronald W.,Wong, Waiken
申请号:
AU2016215182
公开号:
AU2016215182B2
申请日:
2016.02.05
申请国别(地区):
AU
年份:
2019
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.