Solid Dosage Forms of Nootropic Action Based on Pantogam and Succinic Acid

Abstract

In recent years, research related to the search and study of the mode of action of new and used in medicine nootropic agents has been carried out at a high rate. The research related to the search for new combined drugs of nootropic action based on the substances of d-gamma-Pantothenate of calcium and succinic acid, which have neurometabolic, atigipoxic, and adaptogenic properties, is of interest. The purpose of this study was to develop and justify the optimal composition and manufacturing technologies of tablets with nootropic effect and standardise the proposed dosage forms containing Pantogam and succinic acid. The method for preparing the tablet mixture is as follows: all components were weighed in the required amount, Pantogam was placed in the mortar, then succinic acid was added and ground to a consistent white powder. The tablets were pressed on a manual press at a pressure of 120 mn/m2. The coating was applied on a laboratory fluidised bed unit with a single nozzle in a perforated drum with a volume of 1000 ml. The obtained tablets were evaluated according to the requirements for State Pharmacopoeia XIII and State Pharmacopoeia XIV. The comparison of the Pantogam tablets with succinic acid obtained by direct pressing and by wet granulation showed that the method of direct pressing allows obtaining tablets with good physical and mechanical properties and bioavailability. The methods based on acid-base titration and spectrophotometric determination were developed for the quantitative determination of Pantogam in tablets. The method of quantitative determination of succinic acid in dosage forms was validated. Based on the study of physicochemical and technological properties of substances and excipients, the compositions and technology for obtaining tablets containing Pantogam and succinic acid were justified and developed. It was found that solid-phase interactions occur with the combined presence of Pantogam and succinic acid in the tablets. The methods of qualitative and quantitative analysis of dosage forms containing Pantogam and succinic acid based on complexometric titration and high-performance liquid chromatography were developed. The procedure of validation of the method for determining succinic acid by HPLC in the developed dosage forms confirmed the validity of the proposed method.

Keywords

• pantogam
• succinic acid
• tablets
• complexometry
• high-performance liquid chromatography
• validation.