Abstract
Background . Test “Dissolution” is one of the main methods for quality evaluation of solid dosage drug forms, which enables characterization of the drug both in technological and biopharmacological aspects. The test may be also used for comparative studies of drugs bioavailability in vitro. Objective . Development of the “Dissolution” test for the drug Secoisolariciresinol, capsules 100 mg.Materials and methods . The study used: Secoisolariciresinol, capsules 100 mg; hydrochloric acid (c. p.); Twin-80 (Polysorbate LAUROPAN T/80, Italy); purified water (рН 6.5); 0.1 М and 0.2 М solutions of hydrochloric acid; phosphate buffer solution (рН 6.8). Equipment and devices: dissolution tester ERWEKA, series 700, type – paddle mixer (ERWEKA, Germany); recording spectrophotometer Cary-100 (Varian, USA); рН-meter HANNA рН 211 (Hanna Instruments, Germany); analytical balances Sartorius 2405 (Sartorius AG, Germany).Results . Methodology for performing the “Dissolution” test for the drug Secoisolariciresinol, capsules 100 mg was developed according to Russian State Pharmacopoeia (XIV) requirements for solid dosage drug forms.Conclusions . Optimal conditions were chosen for performing the study “Dissolution” for capsules containing 100 mg of secoisolariciresinol. Analytical methodology was designed for quantitative assessment of secoisolariciresinol release from capsules, which enables accurate control of pharmaceutical substance content in different dissolution media. Methodology for the “Dissolution” test of the drug Secoisolariciresinol, capsules 100 mg was developed on the base of the obtained experimental data.
Highlights
Optimal conditions were chosen for performing the study “Dissolution” for capsules containing 100 mg of secoisolariciresinol
Analytical methodology was designed for quantitative assessment of secoisolariciresinol release from capsules, which enables accurate control of pharmaceutical substance content in different dissolution media
Для фармацевтических субстанций II класса тест «Растворение» in vitro наиболее полно отражает абсорбцию in vivo, поскольку для таких веществ стадия высвобождения активного вещества из лекарственных форм (ЛФ) и растворения в физиологических средах в желудочно-кишечном тракте является лимитирующей для абсорбции в системный кровоток [20]
Summary
ТЕСТ «РАСТВОРЕНИЕ» КАК ЭЛЕМЕНТ КОМПЛЕКСНОЙ ОЦЕНКИ КАЧЕСТВА КАПСУЛ, СОДЕРЖАЩИХ СЕКОИЗОЛАРИЦИРЕЗИНОЛ. Цель исследования – разработка теста «Растворение» для лекарственного препарата «Секоизоларицирезинол, капсулы 100 мг». С учетом требований Государственной Фармакопеи XIV издания к твердым дозированным лекарственным формам разработана методика теста «Растворение» для лекарственного препарата «Секоизоларицирезинол, капсулы 100 мг». На основании полученных экспериментальных данных разработана методика теста «Растворение» для лекарственного препарата «Секоизоларицирезинол, капсулы 100 мг». Development of the “Dissolution” test for the drug Secoisolariciresinol, capsules 100 mg. The study used: Secoisolariciresinol, capsules 100 mg; hydrochloric acid Methodology for performing the “Dissolution” test for the drug Secoisolariciresinol, capsules 100 mg was developed according to Russian State Pharmacopoeia (XIV) requirements for solid dosage drug forms. Methodology for the “Dissolution” test of the drug Seco isolariciresinol, capsules 100 mg was developed on the base of the obtained experimental data
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