Test “Dissolution” as an integral part of quality complex evaluation of capsules with sekoisolariciresinol
https://doi.org/10.17650/1726-9784-2019-18-1-95-100
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.
About the Authors
Е. V. Ignаtieva
N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation
Russian Federation
24 Kashirskoe Shosse, Moscow 115478
Russian Federation
24 Kashirskoe Shosse, Moscow 115478
Z. S. Shprakh
N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation;
Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation
Russian Federation
24 Kashirskoe Shosse, Moscow 115478;
Build. 2, 8 Trubetskaya St., Moscow 119991
Russian Federation
24 Kashirskoe Shosse, Moscow 115478;
Build. 2, 8 Trubetskaya St., Moscow 119991
I. V. Yartseva
N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation
Russian Federation
24 Kashirskoe Shosse, Moscow 115478
Russian Federation
24 Kashirskoe Shosse, Moscow 115478
E. V. Sanarova
N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation
Russian Federation
24 Kashirskoe Shosse, Moscow 115478
Russian Federation
24 Kashirskoe Shosse, Moscow 115478
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For citations:
Ignаtieva Е.V., Shprakh Z.S., Yartseva I.V., Sanarova E.V. Test “Dissolution” as an integral part of quality complex evaluation of capsules with sekoisolariciresinol. Russian Journal of Biotherapy. 2019;18(1):95-100. (In Russ.) https://doi.org/10.17650/1726-9784-2019-18-1-95-100
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