Researchers of the Institute of Chemistry and Chemical-Pharmaceutical Technologies of the Altai State University are developing levosalbutamol, as the press service of the university reports. The substance belongs to vital medicines and is intended for the preparation of drugs for patients with bronchial asthma and chronic obstructive pulmonary disease.
This substance is not produced in Russia. Levosalbutamol was created in the 1990s by US-based Sunovion. It contains only the R-isomer of salbutamol. Clinical trials have shown that its broncholytic efficacy is four times higher than that of salbutamol produced in the form of a racemic mixture, and there are fewer adverse effects from the use of the drug.
At the moment, pharmaceutical manufacturers both in Russia and abroad are purchasing a less effective substance in India in the form of a racemic mixture of two enantiomers, it is used to prepare an aerosol which has a significantly lower effectiveness and leads to a number of adverse effects. This makes it crucial to organize the production of levosalbutamol in the Russian Federation in order to meet the need of our country and neighboring countries for this highly effective substance for the preparation of vital medicines in various dosage forms (aerosols, inhalation solutions, etc.).
A research group from the Department of Organic Chemistry of the Institute of Chemistry and Chemical and Pharmaceutical Technologies of AltSU, supervised by Natalia Bazarnova, Doctor of Sciences in Chemistry, Professor, Head of the Department, together with AO Altaivitaminy and N.S. Kurnakov Institute of General and Inorganic Chemistry of the RAS, have conducted research on the development of an aerosol form of salbutamol with an optically pure substance of an R-isomer of salbutamol.
The research was carried out with support from the grant “Creation of a high-tech production of the vital anti-asthma therapy salbutamol in aerosol form based on an enantiomerically pure, micronized substance obtained with supercritical fluid technologies”.
A method has been developed for the preparative separation of racemic salbutamol to obtain an optically pure R-isomer of salbutamol with supercritical fluid chromatography. It is protected by a patent, the owner of which is AO Altaivitaminy. The enterprise has already performed research on the development of a technology for obtaining an optically pure substance.
Altai State University has a semi-preparative supercritical fluid chromatography unit, while AO Altaivitaminy has other equipment necessary for production: an industrial chromatography unit. In order to organize the production of levosalbutamol substance in the form of an optically pure R-isomer, it is necessary to perform some research and development and organize a technological site that meets GMP standards. The university plans to develop this project as part of the import substitution program.
