Аннотация:
A comparative dissolution kinetics test was used to study the release (dissolution kinetics) of an original and 10 generic formulations of omeprazole from different manufacturers in a medium simulating the moderately acidic conditions in the stomach typical of the state of medication-induced suppression of acidity; tests were also performed in a model of pathological duodenogastric reflux. HPLC was used to measure omeprazole concentrations in aliquots collected at 4, 10, 15, 20, 30, 45, and 60 min in solution with pH 7.0 ± 0.05 after 2 h of exposure at pH 1.2 ± 0.05 or 4.0 ± 0.05. The duration of action of pathological duodenogastric reflux on the therapeutic formulations of omeprazole was 4 min. Not all the study formulations could be completely recognized as equivalents to the original formulation in the in vitro test conditions. © 2017, Springer Science+Business Media, LLC, part of Springer Nature.
Vasilenko G. F.
Krasnykh L. M.
Serebrova S. Yu. Svetlana Yuryevna 1971-
Prokofyev A. B. Aleksej Borisovich 1964-
Ramenskaya G. V. Galina Vladislavovna 1972-
Smolyarchuk E. A. Elena Anatolyevna 1974-
Kurguzova D. O.
Barkov A. O.
Василенко Г. Ф.
Краснyх Л. М.
Сереброва С. Ю. Светлана Юрьевна 1971-
Прокофьев А. Б. Алексей Борисович 1964-
Раменская Г. В. Галина Владиславовна 1972-
Смолярчук Е. А. Елена Анатольевна 1974-
Кургузова Д. О.
Барков А. О.
A Comparative Dissolution Kinetics Test for Omeprazole-Containing Medicines, Reproducing Secretory and Motor-Evacuatory Impairments the Stomach of Patients with Acid-Dependent Diseases
A Comparative Dissolution Kinetics Test for Omeprazole-Containing Medicines, Reproducing Secretory and Motor-Evacuatory Impairments the Stomach of...
Текст визуальный непосредственный
Pharmaceutical Chemistry Journal
Springer New York Consultants Bureau
Vol.51, Issue9 P. 824-828
2017
Статья
comparative dissolution kinetics test in vitro equivalence interchangeability omeprazole therapeutic equivalence
generic drug omeprazole Article bioequivalence comparative study drug coating drug formulation drug release drug solubility duodenogastric reflux high performance liquid chromatography kinetics pH stomach pH
A comparative dissolution kinetics test was used to study the release (dissolution kinetics) of an original and 10 generic formulations of omeprazole from different manufacturers in a medium simulating the moderately acidic conditions in the stomach typical of the state of medication-induced suppression of acidity; tests were also performed in a model of pathological duodenogastric reflux. HPLC was used to measure omeprazole concentrations in aliquots collected at 4, 10, 15, 20, 30, 45, and 60 min in solution with pH 7.0 ± 0.05 after 2 h of exposure at pH 1.2 ± 0.05 or 4.0 ± 0.05. The duration of action of pathological duodenogastric reflux on the therapeutic formulations of omeprazole was 4 min. Not all the study formulations could be completely recognized as equivalents to the original formulation in the in vitro test conditions. © 2017, Springer Science+Business Media, LLC, part of Springer Nature.