METHOD OF OBTAINING DABIGATRAN-CONTAINING DRUG COMPOUNDS

摘要

FIELD: medicine, pharmaceutics.SUBSTANCE: invention relates to method of obtaining suspension of polymorphic form I of salt of methanesulfonic acid and dabigatran etexilate of formula I. Method is characterised by the following: polymorphic form I of dabigatran etexilate methanesulfonate with melt temperature t180±3°C is suspended in mixture with talc in solution of hydroxypropylcellulose in isopropyl alcohol at temperature in the range from 12 to 22°C with obtaining suspension by method of circulation dispersion at temperature not higher than 30°C. Invention also relates to obtained in said way suspension for obtaining dabigatran etexilate methanesulfonate pellets. Invention also relates to dabigatran etexilate methanesulfonate pellets used for thrombin inhibition, and to method of obtaining said pellets by dispersion of said suspension on isolated tartaric acid cores in fluidised bed.EFFECT: claimed invention provides industrial method of obtaining pellets of dabigatran etexilate methanesulfonate, presents only in one polymorphic form.27 cl, 5 ex