FIELD: chemistry.
SUBSTANCE: present invention relates to propofol microemulsion for parenteral administration. Propofol microemulsion contains an oil phase in the form of oil drops dispersed in a continuous phase of an aqueous diluent. Oil phase contains propofol, at least one surfactant containing 15-hydroxystearate of polyethylene glycol (solutol HS 15), at least one solvent containing medium chain triglycerides (MCT), at least one additional surfactant and at least one cosolvent. Oil droplets have size of not more than 20 nm in continuous phase. Weight ratio between said at least one solvent and surfactant ranges from 1:8 to 1:12. Microemulsion has monodisperse distribution of size of oil drops. Also described is a diluent-containing propofol concentrate and a method of producing a microemulsion, which comprises diluting a diluentable propofol concentrate in a predetermined amount of a pharmaceutically acceptable aqueous diluent.
EFFECT: microemulsion of propofol according to the invention provides relatively painless introduction of the composition.
25 cl, 7 dwg, 15 tbl, 10 ex
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Authors
Dates
2019-12-23—Published
2016-06-29—Filed