Inhibition of Gastric H⁺,K⁺-ATPase Activity in Vitro by Dissolution Media of Original Brand-Name and Generic Tablets of Lansoprazole, a Proton Pump Inhibitor Inhibition of Gastric H<sup>+</sup>,K<sup>+</sup>-ATPase Activity <i>in Vitro</i> by Dissolution Media of Original Brand-Name and Generic Tablets of Lansoprazole, a Proton Pump Inhibitor

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Author(s)

Abstract

<p>To investigate the inhibitory effect of a commercial proton pump inhibitor (lansoprazole) on the gastric proton pump H<sup>+</sup>,K<sup>+</sup>-ATPase <i>in vitro</i>, we used orally disintegrating (OD) tablets including original brand-name and generic tablets. In the course of the development of generic products, dissolution and clinical tests are necessary to ensure their bioequivalence to the original brand-name products; by contrast, there is almost no opportunity to demonstrate their activity <i>in vitro</i>. This study initially compared the similarity of the dissolution of test generic tablets with that of the original brand-name tablets. The dissolution tests for 15 and 30-mg lansoprazole tablets found their dissolution properties were similar. Subsequently, the dissolution media were sampled and then their effects on the H<sup>+</sup>,K<sup>+</sup>-ATPase activity were measured using tubulovesicles prepared from the gastric mucosa of hogs. We confirmed that the inhibitory effects of the generic tablets on H<sup>+</sup>,K<sup>+</sup>-ATPase activity were consistent with those of the original brand-name tablets. Furthermore, lansoprazole contents in each tablet estimated from their inhibitory effects were in good agreement with their active pharmaceutical ingredient content. To our knowledge, this is the first technical report to compare the <i>in vitro</i> biochemical activity of lansoprazole OD tablets between the original brand-name and generic commercial products.</p>

Journal

  • Chemical and Pharmaceutical Bulletin

    Chemical and Pharmaceutical Bulletin 66(9), 896-900, 2018

    The Pharmaceutical Society of Japan

Codes

  • NII Article ID (NAID)
    130007479597
  • NII NACSIS-CAT ID (NCID)
    AA00602100
  • Text Lang
    ENG
  • ISSN
    0009-2363
  • NDL Article ID
    029184775
  • NDL Call No.
    Z53-D167
  • Data Source
    NDL  J-STAGE 
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