METHOD AND DEVICE FOR PRODUCTION OF SOLID DISPERSION Russian patent published in 2022 - IPC A61K9/16 A61K31/4422 B29C48/04 B29C48/14 B29B9/10 

FIELD: pharmaceutics.

SUBSTANCE: invention relates to the field of pharmaceutics; it can be used for the production of a solid dispersion of nicardipine. A method for extrusion from a melt for the production of a solid dispersion containing a pharmaceutically active ingredient, a polymer binder, and optionally one or more auxiliary substances includes: a) placement in portions of certain amount of the polymer binder, the active ingredient, and optionally the auxiliary substance (substances) to a vessel for melting; melting of the polymer binder in the vessel for melting, while shaking for dispersion of the active ingredient in the polymer binder to obtain a molten pre-dispersion; b) supply of pre-dispersion to an extruder for homogenization of the pre-dispersion, and release of the melt through a head; and c) provision for the melt of a possibility for curing. At the same time, the active ingredient is selected from nicardipine, its pharmaceutically acceptable salt, hydrate, or solvate, and the polymer binder contains (i) poly(copolymer of lactide and glycolide) having molecular weight distribution centered around average molecular weight Mn2, and (ii) poly(copolymer of lactide and glycolide) having molecular weight distribution centered around average molecular weight Mn1, where Mn1 is in a range from 2000 to 3000 g/mol, and the ratio of Mn1/Mn2 is from 1.8 to 3.5.

EFFECT: method provides for high homogeneity of active substance in a dispersion with minimum efforts.

9 cl, 3 tbl, 2 ex