PHARMACEUTICAL COMPOSITIONS CONTAINING HIGH-PURITY CANGRELOR, AND METHODS FOR PRODUCTION AND USE THEREOF Russian patent published in 2020 - IPC A61K31/7076 A61K47/00 A61K47/26 A61J1/00 A61P9/00 

FIELD: chemical-pharmaceutical industry.

SUBSTANCE: method of producing a pharmaceutical composition containing high-purity cangrelor or a salt thereof as an active ingredient and one or more pharmaceutically acceptable carriers, includes (a) dissolving of a cangrelor or a salt thereof in a solvent to form a first solution; (b) mixing the pH-control agent with the first solution to form a second solution, wherein pH of second solution is 7–9.5; and (c) removing the solvent from the second solution to obtain high purity cangrelor or a salt thereof in conditions where a moisture level of less than 2.0 wt % is achieved, wherein one or more pharmaceutically acceptable carriers are added to the first solution, or to the second solution, or to both, where mixing (b) is carried out in the absence of light, or is carried out in a nitrogen atmosphere, or under both conditions; in which the high purity cangrelor or its salt contains a total of certain degradation products of the cangrelor as a result of hydrolysis or oxidation in an amount, not exceeding 1.5 wt % of cangrelor. Other versions of the method for preparing the pharmaceutical composition are also disclosed.

EFFECT: group of inventions enables to obtain a composition of cangrelor with low content of impurities.

13 cl, 5 tbl, 6 ex