A method of preparing a pharmaceutical composition based on zoledronic acid in the form of an infusion solution for the treatment of cancer and a method for producing a pharmaceutical composition based on zoledronic acid in the form of a concentrate for preparing a solution for infusion for the treatment of cancer

摘要

FIELD: medicine.SUBSTANCE: group of inventions refers to medicine, namely to oncology, and can be used to produce zoledronic acid in the form of an infusion solution. Methods according to the invention include preparation of zoledronic acid solution with continuous stirring in a stainless steel reactor, the inner surface of which has Teflon coating, with mannitol and sodium citrate at certain ratios between them and with heating of the solution while stirring them during 119–121 min with gradual increase of temperature from 60 °C to 80 °C. After that, solution sterilizing filtration is performed first through the depth filter and then through the membrane filter.EFFECT: use of inventions enables to obtain a pharmaceutical composition exhibiting pharmacological activity at lower doses, increasing its stability during storage, increasing its sterility and manufacturing it using a simpler technology.3 cl, 2 tbl, 3 ex