METHOD OF PREVENTING PRECIPITATION IN INJECTION SOLUTION CONTAINING P-BORONOPHENYLALANINE Russian patent published in 2025 - IPC A61K9/08 A61K31/69 A61K47/12 A61K47/26 A61P35/00 

FIELD: chemistry; pharmaceutics.

SUBSTANCE: group of inventions relates to chemistry and pharmaceutics, namely to versions of a method for preventing precipitation in an injection solution for boron-neutron capture therapy at temperature of 5 ± 3 °C. In one embodiment, the method comprises preparing an injection solution containing p-boronophenylalanine or a pharmaceutically acceptable salt thereof, sorbitol and a pH-regulating agent, where the pH is adjusted by adjusting to values higher than 7.5 and to 7.8, wherein the concentration of p-boronophenylalanine (or a pharmaceutically acceptable salt thereof) is 2.0–5.5 wt./vol.%, concentration of sorbitol is 2.6–6.5 wt./vol.% and the molar ratio of sorbitol to p-boronophenylalanine (or a pharmaceutically acceptable salt thereof) is in range of (0.9–3.0):1. In another embodiment of the method, the injection solution contains citric acid as a pH-regulating agent, and the pH is controlled at level from 7.1 to 7.4.

EFFECT: group of inventions provides stability of the injection solution at low temperatures.

3 cl, 4 tbl, 18 ex