POWDER FOR A SOLUTION HAVING NEUROPROTECTIVE ACTIVITY FOR YOUNG CHILDREN

Introduction. Neuroprotective agents, including valerian (Valeriana officinalis) preparations, are widely used to treat nervous system diseases in adults and children. Registration of dry valerian extract in the State Register of Medicines of Russia allows the design of dry mixtures for an oral solution, which are a versatile pediatric dosage form. Objective: to implement a technological and analytical control of the quality of powder for a solution having neuroprotective activity for oral pediatric use; to choose a package for a metered-dose finished product to be long stored with a view to its commercial manufacture. Material and methods. The components of the powder were qualitatively and quantitively controlled by current analytical methods, by using physicochemical, technological, and microbiological techniques. The amount of sesquiterpenic acids was quantified with reference to valeric acid by high performance liquid chromatography according to the procedure developed by the authors. Results. The technological characteristics (flowability, repose angle, tapped density) of powder mass suggest that the latter belongs to average-weight powders. Therefore, it does not require any special process techniques. The powder mass of the above composition can be prepared if there are standard climatic parameters (a temperature of 20±2°C, a relative humidity of about 65%). A special package (sachets that are heat-sealed bags from combined film material with a polyethylene coating) is proposed to preserve the stability of the powder during long-term storage. Conclusion. Technology and methods for controlling the quality of the powder’s components have been developed to prepare an oral pediatric neuroprotective solution that contains sodium bromide, magnesium sulfate, dry valerian extract, and dextrose. The chemical composition and microbiological purity of metered-dose powders for an oral solution as sachets have been established to be 6 months (a follow-up period).