FIELD: medicine; pharmaceuticals.
SUBSTANCE: invention relates to medicine, pharmaceutics, food industry and veterinary medicine. Process for the preparation of a microemulsion of biologically active substances (BAS) comprises the homogenization of the oil phase of BAS with an emulsifier which contains at least one nonionic surfactant with a hydrophilic-lipophilic balance number of 10-18 and its subsequent mixing with the aqueous phase. All components of the microemulsion are selected so that the lower temperature boundary of the phase inversion lies within the range of 60-90°C. Temperature of the oil phase is set in the range from the phase inversion temperature to 100°C by dissolving the BAS in the part of the emulsifier heated to a temperature in the range from 100 to 180°C, and then adding the remainder of the emulsifier having a temperature below 100°C. In the second variant of the method, refractory BAS is dissolved in low-melting BAS heated to the appropriate temperature. Cooling of the oil phase is also carried out by the addition of an emulsifier. Phase mixing is carried out by adding an aqueous phase to the oil phase having a temperature of 20°C to the temperature of the oil phase. After that, the resulting mixture is cooled.
EFFECT: invention makes it possible to increase manufacturability and reduce the number of operations in the production of microemulsions of BAS, simplify the choice of microemulsion components and expand the range of BAS, as well as increase the stability and resistance of the resulting system to external influences and extend its shelf life.
16 cl, 2 ex
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Authors
Dates
2018-06-08—Published
2015-11-26—Filed