DEVELOPMENT AND VALIDATION OF THE METHOD OF KINETIC EVALUATION OF MEDICAL SUBSTANCE TOPIRAMAT DISSOLUTION BY LASER DIFFRACTION OF LIGHT METHOD
Abstract
Solubility is the most important quality indicator, reflecting the physicochemical properties of active pharmaceutical ingredients (APIs). Prior to the release of API, solubility is one of the key factors affecting the efficacy and safety of drugs. Therefore, the directed development of new drugs with predetermined properties (drug design) should be basedon solubility of candidate substances and be taken into account when evaluating the bioequivalence of generic drugs branded, including in vitro - in vivo correlation. Given that the pharmacopeia regulation of the test for the solubility of API is reduced to a visual estimate and approximate solubility, we developed a kinetic dissolution evaluation method by laser diffraction and performed statistical analysis of the results obtained under repeatability conditions.
About the Authors
E. V. Uspenskaya
People Friendship University of Russia
Russian Federation
Russian Federation
A. A. Keshishian
People Friendship University of Russia
Russian Federation
Russian Federation
M. V. Nikiforova
People Friendship University of Russia
Russian Federation
Russian Federation
T. V. Pletneva
People Friendship University of Russia
Russian Federation
Russian Federation
A. V. Syroeshkin
People Friendship University of Russia
Russian Federation
Russian Federation
References
1. C.J. Craven. A model to explain specific cellular communications and cellular harmony: a hypothesis of coupled cells and interactive coupling molecules // Theor Biol Med Model. 2014. V. 11. Р. 40-47. doi: 10.1186/1742-4682-11-40.
2. О.Д. Казанчева, А.С. Герасименко. Методология поиска новых биологически активных фармакологических веществ с рецепторной активностью // International journal of applied and fundamental research. 2016. № 8. Р. 522-525.
3. E.J. Miller, E. Jecs, V.M. Truax, B.M. Katzman, Y.A. Tahirovic, R.J. Wilson, K.M. Kuo, M.B. Kim, H.H. Nguyen, M.T. Saindane, H. Zhao, T. Wang, C.S. Sum, M.E. Cvijic, G.M. Schroeder, L.J. Wilson, D.C. Liotta. Discovery of Tetrahydroisoquinoline-Containing CXCR4 Antagonists with Improved in Vitro ADMET Properties // J Med Chem. 2018. V. 61. №(3). Р. 946-979. doi: 10.1021/acs.jmedchem. 7b01420.
4. Е.Р. Бригас, Е.В. Успенская, В.В. Писарев. Изучение сравнительной кинетики растворения антигипертензивных лекарственых средств II класса биофармацевтической классификационной системы в соответствии с процедурой «биовейвер» // Разработка и регистрация лекарственных средств. 2016. № 4(17). С. 152-158.
5. S.V. Dorozhkin. Dissolution mechanism of calcium apatites in acids: A review of literature // World J Methodol. 2012. V. 2(1). Р. 1-17.
6. G.L. Perlovich, T.V. Volkova, A.N. Manin, A. Bauer-Brandl. Influence of Position and Size of Substituents on the Mechanism of Partitioning: A Thermodynamic Study on Acetaminophens, Hydroxybenzoic Acids, and Parabens // AAPS PharmSciTech. 2008. V. 1. Р. 205-216.
7. Е.В. Анфимова, Е.В. Успенская, Т.В. Плетенева, А.В. Сыроешкин. Исследование кинетики растворимости лекарственных субстанций методом лазерной дифракции в водных растворах с различным изотопным составом по водороду // Разработка и регистрация лекарственных средств. 2017. № 1(18). С. 150-155.
8. S. Huang, C. Mao, R.O. Williams, C.Y. Yang. Solubility Advantage (and Disadvantage) of Pharmaceutical Amorphous Solid Dispersions // J Pharm Sci. 2016. V. 105. № 12. Р. 3549-3561. doi: 10.1016/j.xphs.2016.08.017.
9. Государственная фармакопея Российской Федерации. XIII изд. Т. 1. / МЗ РФ. - М. 2015. 1470 с.
10. H.N. Chapman, C. Caleman. Diffraction before destruction // B Biol Sci. 2014. № 17. Р. 369-1647.
11. V. Prince, K.C. Bowling. Topiramate in the treatment of cocaine use disorder // Am J Health Syst Pharm. 2018. V. 75. № 1. Р. 13-22. doi: 10.2146/ajhp160542.
12. E. Bruno, A. Nicoletti, G. Quattrocchi, R. Allegra, G. Filippini, C. Colosimo, M. Zappia. Topiramate for essential tremor // Cochrane Database Syst Rev. 2017. V. 4. doi: 10.1002/14651858. CD009683.pub2.
13. Н. Уварова, У Борисова. Исследование растворимости субстанции бендазола гидрохлорида методом лазерной дифракции // НПЖ «Фармация». Сборник материалов V Юбилейной Всероссийской научной конференции студентов и аспирантов с международным участием «Молодая фармация - потенциал будущего - СПб.: СПХФА, 2015. С. 510-513.
14. U. Borisova, N. Uvarova. Study of solubility kinetics for pharmaceutical substances by laser dif fraction method // VI International Scientific Conference «SCIENCE4HEALTH 2015». Мaterials of the conference: PFUR, Moscow. С. 32-33.
15. S. Zhao, G. Huang, S. Mu, C. An, X. Chen. Immobilization of phenanthrene onto gemini surfactant modified sepiolite at solid/aqueous interface: Equilibrium, thermodynamic and kinetic studies // Science of the Total Environment. 2017. V. 598. Р. 619-627.
16. R.M. Khusainova, Z.V. Shilova. Selection of Appropriate Statistical Methods for Research Results Processing // Mathematics Education. 2016. V. 11. № 1. Р. 303-315.
Review
For citations:
Uspenskaya E.V., Keshishian A.A., Nikiforova M.V., Pletneva T.V., Syroeshkin A.V. DEVELOPMENT AND VALIDATION OF THE METHOD OF KINETIC EVALUATION OF MEDICAL SUBSTANCE TOPIRAMAT DISSOLUTION BY LASER DIFFRACTION OF LIGHT METHOD. Drug development & registration. 2018;(2):72-76. (In Russ.)
Views:
805
Email this article 