Author:
D.S. Volokitina,S.V. Volokitin,A.M. Shevchenko
Abstract
Abstract. Currently, intensive research is being conducted in the study of new biologically active substances for medical use that will be effective and safe for human use. Before the production of a medicinal product, the technological parameters and characteristics of a pharmaceutical substance must be carefully studied and scientifically substantiated. When creating and modernizing the technology of dosage forms, one of the most important stages is the assessment of bioavailability. It, in turn, depends on the physico-chemical properties of the active substance. The present work is devoted to the study of the technological properties of the original pharmaceutical substance of the quinazoline derivative, used as an active substance for the development of the composition and technology for obtaining a dosage form for oral use in the form of tablets using solid dispersion. The technological characteristics of a new biologically active compound –a derivative of quinazoline: 3-[2-(2-Methylphenylamino)-2-oxoethyl]-quinazoline-4(3H)–oh (laboratory code: VMA–10–13), capable of influencing pharmacological activity in the production of the dosage form, have been studied. The study examined key indicators: residual moisture, bulk density, flowability, ejection pressure, compressibility and disintegration of model tablets. The composition and technology of obtaining a solid dosage form (tablets) using a solid dispersion with improved biopharmaceutical characteristics have been developed. The main pharmaceutical and technological indicators of tablet quality are determined: average weight and disintegration. The data obtained allowed us to assume the content and course of further stages of pharmaceutical development.
Subject
General Earth and Planetary Sciences,General Environmental Science
Reference5 articles.
1. The State Pharmacopoeia of the Russian Federation [Electronic resource]. - 14th ed. - Moscow: Ministry of Health of the Russian Federation, 2018. – Vol. 2. Access mode: http://femb.ru/femb/pharmacopea.php.
2. Reshetnyak, V.Yu. Solid dispersions with polyethylene glycols in pharmacy / V.Yu. Reshetnyak, V.A. Popkov, Yu.V. Skovpen, I.I. Krasnyuk // Pharmacy, 2005. − No. 3. − pp. 39-42.
3. Solid dispersions with polyethylene glycols in pharmacy / V.A. Popkov [et al.] // Pharmacy. - 2005. - No. 2. – pp. 39-42.
4. Tentsova, A.M. Solid dispersed systems in pharmacy / A.I. Tentsova, A.E. Dobrotvorsky // Pharmacy. − 1981. − No. 2. − p. 65.
5. Teslev, A. A. On the issue of the use of solid disperse systems to improve the biopharmaceutical characteristics of medicines / A. A. Teslev // Pharmaceutical technologies and packaging. – 2014. – No. 2. – pp. 18-21.