SPIREAS Spiridon,СПИРЕАС Спиридон,PAIYA Ishari,ПАИЯ Ишари,GROVER Rakesh,ГРОВЕР Ракеш,SEDZHI Sanil,СЭДЖИ Санил,KELLUR Rem K.,КЭЛЛУР Рэм К.
申请号：
RU2013131602
公开号：
RU0002606845C2
申请日:
2011.12.09
申请国别(地区):
RU
年份:
2017
代理人:
摘要：
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 exГруппа изобретений относится к медицине и фармакологии и может быть использована для получения твердой фармацевтической композиции, причем твердая фармацевтическая композиция содержит: (i) аморфный твердый раствор 9-[2-[бис[(пивалоилокси)-метокси]фосфинил]метокси]этил]аденина (AD) и сополимера винилпирролидона и винилацетата и (ii) один или более фармацевтически приемлемых неактивных инг
