Аннотация:
We have proposed and verified the hypothesis, according to which the pathologic duodenogastric reflux (PDR) and acid-suppressing medication can reduce the stability of enteric-coated forms of omeprazole. A modified comparative dissolution kinetics test was used to estimate the release kinetics of original omeprazole (00) and four generic forms of this drug (GD1, GD2, GD3, GD4) under slightly acidic conditions common to pharmacological acid suppression and the experimental PDR model. The omeprazole concentration in aliquots taken 0,4,10,15,20,30,45, and 60 min at pH 7.0 ± 0.05 after 2 h exposure at pH 1.2 ± 0.05 or pH 4.0 ± 0.05 was determined by ERWEKA DT 600 dissolution tester in combination with high performance liquid chromatography (HPLC). The PDR exposure time on omeprazole was 4 min. The OO and GD2 demonstrated pharmaceutical equivalence, whereas GDI, GD3 and GD4 did not. The latter three samples were broken down by PDR in the stomach. Moreover, GD3 could also be broken down due
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Прокофьев А. Б. Алексей Борисович 1964-
Краснyх Л. М.
Василенко Г. Ф.
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Смолярчук Е. А. Елена Анатольевна 1974-
Кургузова Д. О.
Барков О. А.
Serebrova S. Yu. Svetlana Yuryevna 1971-
Prokofyev A. B. Aleksej Borisovich 1964-
Krasnykh L. M.
Vasilenko G. F.
Zhuravleva M. V. Marina Vladimirovna 1958-
Kareva E. N. Elena Nikolaevna 1961-
Gorodetskaya G. I. Galina Ivanovna 1964-
Eremenko N. N. Natal`ya Nikolaevna 1979-
Smolyarchuk E. A. Elena Anatolyevna 1974-
Kurguzova D. O.
Barkov O. A.
On the possibility of predicting the inefficacy of omeprazole generics in patients with acid-dependent disorders of gastrointestinal tract
Текст визуальный непосредственный
Экспериментальная и клиническая фармакология
ООО "Фолиум"
Т. 80, Вып. 6 С. 24-29
2017
Статья
Antisecretory treatment Comparative drug dissolution test Duodenogastric reflux Generics Interchangeability Omeprazole Pharmaceutical equivalence Therapeutic equivalence
omeprazole Article drug determination drug efficacy drug solubility duodenogastric reflux high performance liquid chromatography human pH pharmaceutical equivalence
We have proposed and verified the hypothesis, according to which the pathologic duodenogastric reflux (PDR) and acid-suppressing medication can reduce the stability of enteric-coated forms of omeprazole. A modified comparative dissolution kinetics test was used to estimate the release kinetics of original omeprazole (00) and four generic forms of this drug (GD1, GD2, GD3, GD4) under slightly acidic conditions common to pharmacological acid suppression and the experimental PDR model. The omeprazole concentration in aliquots taken 0,4,10,15,20,30,45, and 60 min at pH 7.0 ± 0.05 after 2 h exposure at pH 1.2 ± 0.05 or pH 4.0 ± 0.05 was determined by ERWEKA DT 600 dissolution tester in combination with high performance liquid chromatography (HPLC). The PDR exposure time on omeprazole was 4 min. The OO and GD2 demonstrated pharmaceutical equivalence, whereas GDI, GD3 and GD4 did not. The latter three samples were broken down by PDR in the stomach. Moreover, GD3 could also be broken down due