FIELD: medicine; pharmaceutics.
SUBSTANCE: invention refers to pharmaceutics and medicine and can be used for prevention and/or treatment of solid organ transplant rejection. Disclosed is a method of producing nanoparticles containing tacrolimus or a salt thereof, involving the following steps: a) providing a solution of tacrolimus or a salt thereof in an organic solvent; b) providing a liquid precipitant for tacrolimus or a salt thereof; c) depositing nanoparticles containing tacrolimus or a salt thereof by colliding the stream of the organic solvent from point a) with the stream of the precipitant from point b); and d) separating nanoparticles, wherein the nanoparticles have size of 10 to 400 nm. Solvent includes ethanol, methanol, acetone and / or tetrahydrofuran; precipitation agent includes water; liquid flows collide at a speed of about 1 m/s to about 100 m/s; and the volume ratio of the solvent to the precipitant is between about 1:1 and about 1:5. Group of inventions also relates to a mucoadhesive buccal film containing at least one matrix layer containing tacrolimus nanoparticles obtained using said method, and at least one polymer.
EFFECT: obtained nanoparticles of tacrolimus provide significant reduction of dissolution time, as well as increased solubility during saturation, which enables to provide fast transfer of tacrolimus into blood and fast onset of action of mucoadhesive film containing such particles, compared to the oral route of administration.
11 cl
