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A Comparative Dissolution Kinetics Test for Omeprazole-Containing Medicines, Reproducing Secretory and Motor-Evacuatory Impairments the Stomach of Patients with Acid-Dependent Diseases

  • STRUCTURE OF CHEMICAL COMPOUNDS, METHODS OF ANALYSIS AND PROCESS CONTROL
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Pharmaceutical Chemistry Journal Aims and scope

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.

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Authors and Affiliations

  1. Scientific Center for Expert Evaluation of Medical Products, Ministry of Health of the Russian Federation, Building 2, 8 Petrovskii Boulevard, 127051, Moscow, Russia

    G. F. Vasilenko, L. M. Krasnykh, S. Yu. Serebrova, A. B. Prokof’ev & G. V. Ramenskaya

  2. I. M. Sechenov First Moscow State Medical University, Ministry of Health of the Russian Federation (Sechenov University), Building 2, Moscow, Russia

    S. Yu. Serebrova, A. B. Prokof’ev, G. V. Ramenskaya, E. A. Smolyarchuk, D. O. Kurguzova & A. O. Barkov

Authors
  1. G. F. Vasilenko
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  2. L. M. Krasnykh
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  3. S. Yu. Serebrova
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  4. A. B. Prokof’ev
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  5. G. V. Ramenskaya
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  6. E. A. Smolyarchuk
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  7. D. O. Kurguzova
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  8. A. O. Barkov
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Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 51, No. 9, pp. 55 – 59, September, 2017.

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Vasilenko, G.F., Krasnykh, L.M., Serebrova, S.Y. et al. A Comparative Dissolution Kinetics Test for Omeprazole-Containing Medicines, Reproducing Secretory and Motor-Evacuatory Impairments the Stomach of Patients with Acid-Dependent Diseases. Pharm Chem J 51, 824–828 (2017). https://doi.org/10.1007/s11094-017-1700-6

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  • DOI: https://doi.org/10.1007/s11094-017-1700-6

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