FIELD: medicine, pharmaceutics.
SUBSTANCE: invention relates to pharmaceutical area, in particular to pharmaceutical compositions represented in the form of microparticles-depots. Method for production of octreotide acetate microparticles includes the following stages: a) solution or dispersion of octreotide acetate in methylene chloride, containing dissolved linear copolymer of lactide with glycolide, to produce dispersion; b) combination of specified dispersion with efficient amount of water buffer medium with stabiliser; c) production of microparticles. Pharmaceutical composition of prolonged action for parenteral introduction, contains microparticles together with dissolvent, includes, apart from non-ionogenic surfactant and agglomeration-preventing substance, such as mannitol, soaking substance and substance that increases viscosity; soaking substance of dissolvent represents Pluronic F 68; dissolvent additionally includes substance to produce isotonic solution. Package is intended for sale and includes specified pharmaceutical composition.
EFFECT: invention facilitates manufacturing of high purity preparation.
7 cl, 4 ex
Authors
Dates
2010-11-27—Published
2003-11-18—Filed