READY-TO-USE FORMULATION FOR LIPOSOMAL INJECTION OF VINCRISTINE SULFATE

摘要

FIELD: pharmaceuticals.;SUBSTANCE: group of inventions relates to chemical and pharmaceutical industry and is a method for treatment of cancer and cancer recurrence in a mammal, including the administration of a therapeutic amount of a vincristine composition. Ready-to-use composition of vincristine contains a continuous aqueous phase containing the first aqueous buffer, the liposomal phase dispersed in the first aqueous buffer and the stabilizing aqueous solution encapsulated as content in the liposomal phase; wherein the stabilizing aqueous solution contains a second aqueous buffer and stabilized vincristine dissolved therein; while the second aqueous buffer contains a salt having at least one dissolved substance, which can transfer from the liposomal phase and leave a positively charged solute or hydronium ion in a stabilizing aqueous solution, while a positively charged solute or hydronium ion stabilizes vincristine. In this case, the difference between the pH levels of the continuous aqueous phase and the stabilizing aqueous solution, which has a sufficiently low pH to ensure the acid-base equilibrium of vincristine, is at least 2 pH units. Group of inventions also includes a method for stabilizing vincristine in a liposome.;EFFECT: group of inventions allows to obtain a stable ready-to-use pharmaceutical composition without multi-stage preparation of the drug.;37 cl, 1 dwg, 5 tbl, 3 ex