Pharmaceutical development: innovative dosage form of piracetam


E.V. Kovtun(1), Е.F. Stepanova(1), M.M.Y. Dadou(1), E.I. Morkovin(2), А.А. Markaryan(3)
1-Рyatigorsk Medical and Pharmaceutical Institute – branch of the Volgograd State Medical University, Ministry of Health of the Russian Federation, Kalinin Ave., 11, Pyatigorsk, 357532, Russian Federation;
2-Volgograd State Medical University, Ministry of Health of the Russian Federation, State Budgetary Institution "Volgograd Medical Research Center", 1, Pavshikh Bortsov Sq., Volgograd, 400131, Russian Federation;
3-State budgetary educational institution of higher education “Moscow State Medical and Dental University named after A.I. Evdokimov" of the Ministry of Health of the Russian Federation, Delegatskaya street, 20/1, Moscow, 127473, Russia

Introduction. The development of a dosage form is always associated with the need to resolve issues related not only to the bioavailability and stability of the drug, but also to creating comfortable conditions for administration, including acceptable organoleptic characteristics, which is especially important in geriatrics and pediatric practice. It is syrup as a dosage form that is a special pharmaceutical product; it contains medicinal substances and a complex of excipients that correct its organoleptic properties. The purpose of this study is to develop technology and evaluate the pharmacological activity of medicinal syrup with piracetam. Material and methods. To obtain the syrup, piracetam substance, mint and valerian tinctures were used. When determining the density of the syrup, generally accepted methods were used. The quality of the resulting medicinal syrup and the quantitative determination of piracetam were assessed by reverse-phase high-performance liquid chromatography (HPLC). To assess the pharmacological activity of the resulting syrup, a series of behavioral tests were carried out on 30 male white laboratory rats (body weight 352.3±58.9 g), divided into 3 groups of 10 animals each. Statistical processing of the results was performed using the GraphPad Prism 5.0 program. The correspondence of the distribution of analyzed values to the normal distribution was assessed using the Kolmogorov-Smirnov and Shapiro–Wilk tests. The statistical significance of intergroup differences was assessed using one-way analysis of variance (ANOVA) with Newman–Keuls post-test. Results. A medicinal syrup with piricetam was obtained, which also contains tinctures of valerian and mint. The syrup was standardized according to density. The content of piracetam in the resulting syrup was quantitatively determined. The pharmacological activity of the resulting medicinal syrup was assessed. Conclusion. The resulting medicinal syrup meets the requirements of the ND in terms of density. The results obtained from assessing the pharmacological activity suggest that the study drug piracetam in syrup dosage form, due to the introduction of additional active ingredients into the composition, has additional anxiolytic properties not associated with muscle relaxant effects, which makes further study of the developed dosage form promising.

innovative dosage forms
medicinal syrup.

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