Development of quality indicators for an ethanol infusion in a glucose solution as an antidote for surrogate alcohol poisonings

Introduction. Intoxication with alcohol and its surrogates are continuously recorded in many countries of the world, being one of the leading causes of hospitalizations and death in patients with acute chemical poisonings. However, the Register of Medicines of the Russian Federation has not currently registered an antidote used to treat surrogate alcohol poisonings. Objective: to develop technology and parameters for standardization of ethanol infusions. Material and methods. Glucose (dextrose) and ethanol that met the requirements of Pharmaceutical Article (PA) 2.1.0036.15 of the 14th edition of the RF SP were utilized; the reverse osmosis system of the research and production association «Filterra» was used to prepare water. The quality indicators of the solution were determined using a «Svetlyachok» (Firefly) visual control device; a Mettler Toledo Five Easy 20 pH meter with a universal integrated LE438 IP67 electrode with temperature sensor, an IRF-454B2M laboratory refractometer and a Crystallux 4000M gas chromatograph with a flame ionization detector, and a sterilizer. The stability of the solution was determined in the IB-15G thermostat (JeioTech, Korea). Outbred albino male rats weighing 195-314 g were used to determine the efficacy of the obtained solution for acute methanol and ethylene glycol poisonings. Results. Procedures were developed for the qualitative and quantitative determination of ethanol and glucose in a 5% infusion of ethanol in a 5% glucose solution, by adding a Weibel stabilizer. The stability of the agent was evaluated under conditions of accelerated aging. The infusion solution of the proposed composition was found to be stable throughout the duration of the experiment, which corresponds to 3 years of room-temperature storage. The primary evaluation of the efficiency of using the ethanol infusion of the proposed composition was made according to the survival rate after experimental acute surrogate alcohol poisonings in laboratory animal experiments. Conclusion. A technology was developed to produce a 5% solution of ethanol in a 5% glucose solution. The parameters of standardization of this dosage form were proposed. The estimated expiration date was determined. The developed methods were validated.