FIELD: pharmaceutics.
SUBSTANCE: group of inventions refers to medicine and pharmacology, and can be used for preparing solid pharmaceutical composition, wherein the solid pharmaceutical composition contains: (i) amorphous solid solution of 9-[2-[bis[(pivaloiloxy)-methoxy]phosphinyl]methoxy]ethyl]adenine (AD) and a copolymer of vinylpyrrolidone and vinyl acetate and (ii) one or more pharmaceutically acceptable inactive ingredients selected from microcrystalline cellulose, silicon dioxide and magnesium stearate, wherein the solid pharmaceutical composition is stable, such that when the solid pharmaceutical composition is stored at 40 °C and relative humidity of 75 % in a closed container for 3 months, amount of impurities presented in the solid pharmaceutical composition, is not more than 0.74 weight. % in relation to the initial number of AD, wherein the admixture is 9-[2-(pivaloiloxy)-methoxyphosphinyl]methoxy]ethyl]adenine; at that, the method comprises the following steps: (i) producing amorphous solid solution of AD and copolymer of vinylpyrrolidone and vinyl acetate by dissolving the initial quantity of AD and copolymer of vinylpyrrolidone and vinyl acetate in a volatile organic solvent selected from ketones and halocarbons, evaporation of the volatile organic solvent and (ii) dry mixing of the obtained amorphous solid solution with one or more pharmaceutically acceptable inactive ingredients. Solid pharmaceutical composition and packing system are also disclosed.
EFFECT: group of inventions ensures production of highly-stable composition having storage stability.
10 cl, 5 tbl, 3 ex
