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<p>The comparative dissolution kinetics test (CDKT) remains an indispensable tool for <i>in vitro</i> investigation of drugs. This method aims to establish the equivalence of dissolution profiles under conditions close to physiological in the gastrointestinal tract. The stability of the original product (OP) of rabeprazole sodium and its generics (Razo<sup>®</sup> and GP1) was examined under the modeled conditions using a two-stage CDKT simulating pathological duodenogastric reflux (PDGR) and pharmacological acid suppression. Rabeprazole sodium was quantitatively determined using an Agilent 1200 liquid chromatograph with a spectrophotometric detector. The results of the comparative dissolution kinetics and the calculation of the convergence factor revealed the equivalence of the dissolution profiles of OP and Razo<sup>®</sup> in a dissolution medium with pH 7 after a two-hour exposure in media with pH 1.2 and pH 4.5. GP1 was deemed non-equivalent to the OP because of significant differences in the release dynamics of the active substance in the studied dissolution media. The PDGR model demonstrated that the GP1 dosage form did not preserve the integrity of rabeprazole molecules under the simulated pathophysiological conditions characteristic of patients with acid-related diseases.</p>

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Release Kinetics of Rabeprazole from Dosage Forms of Different Manufacturers

  • 期刊论文

  • 发表日期：

    2025年3月1日

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  • S. Yu. Serebrova,
  • D. O. Kurguzova,
  • L. M. Krasnykh,
  • A. V. Kolyachkina,
  • E. Yu. Demchenkova,
  • M. V. Zhuravleva,
  • E. N. Kareva,
  • E. B. Bashmakova,
  • N. B. A. B. LazarevaProkofiev

摘要

The comparative dissolution kinetics test (CDKT) remains an indispensable tool for in vitro investigation of drugs. This method aims to establish the equivalence of dissolution profiles under conditions close to physiological in the gastrointestinal tract. The stability of the original product (OP) of rabeprazole sodium and its generics (Razo® and GP1) was examined under the modeled conditions using a two-stage CDKT simulating pathological duodenogastric reflux (PDGR) and pharmacological acid suppression. Rabeprazole sodium was quantitatively determined using an Agilent 1200 liquid chromatograph with a spectrophotometric detector. The results of the comparative dissolution kinetics and the calculation of the convergence factor revealed the equivalence of the dissolution profiles of OP and Razo® in a dissolution medium with pH 7 after a two-hour exposure in media with pH 1.2 and pH 4.5. GP1 was deemed non-equivalent to the OP because of significant differences in the release dynamics of the active substance in the studied dissolution media. The PDGR model demonstrated that the GP1 dosage form did not preserve the integrity of rabeprazole molecules under the simulated pathophysiological conditions characteristic of patients with acid-related diseases.