Evaluation of Fast Disintegrating Lansoprazole Tablet in Human Subjects

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  • IWASAKI Koji
    Department of Pharmacokinetics, Kyoto Pharmaceutical University Department of Clinical Development, Takeda Chemical Industry
  • YOSHIKAWA Yukako
    Department of Pharmacokinetics, Kyoto Pharmaceutical University
  • SHIBATA Nobuhito
    Department of Pharmacokinetics, Kyoto Pharmaceutical University
  • TAKADA Kanji
    Department of Pharmacokinetics, Kyoto Pharmaceutical University
  • SAKURAI Yuichi
    Department of Clinical Data Management and Biostatistics, Takeda Chemical Industry
  • TAKAGI Naoshi
    Department of Regulatory Affairs, Takeda Chemical Industry
  • IRIE Shin
    Kyushu Clinical Pharmacology Research Clinic
  • NAKAMURA Koichi
    Department of Clinical Pharmacology and Therapeutics, Oita University, Faculty of Medicine

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  Fast disintegrating lansoprazole tablet (LFDT) has been developed as a multiple unit formulation and evaluated using human subjects as compared to the conventional lansoprazole (LPZ) capsule containing enteric coated granules. Twelve healthy male volunteers, who were confirmed as extensive metabolizers (EMs) based on the plasma levels of LPZ sulphone metabolite, were enrolled into the study and genotype of CYP2C19 was confirmed. They kept 30 mg LFDT in their mouths for 2 min and the saliva was recovered without swallow. Eight subjects did not show LPZ in their serum after intake. Although LPZ was detected in 4 subjects' serum, their concentrations were less than 5 ng/mL. LPZ was thought to be not absorbed from the oral cavity. LFDT was orally administered to 12 healthy male EMs at two doses, 15 mg and 30 mg, and serum LPZ concentrations were measured. The mean Cmax and AUC0-24 were 474.1±254.0 ng/mL and 1105.3±1101.4 ng·h/mL (15 mg) and 992.8±384.3 ng/mL and 2216.5±1270.1 ng·h/mL (30 mg). By comparing to that obtained after oral administration of the same doses of LPZ capsule, serum LPZ concentration vs. time curve was almost the same level, i.e., Cmax and AUC0-24 did not have significant differences. From these results, LFDT has been shown to be equivalent to LPZ capsule and will show the same acid suppressing effects in the clinical situation.<br>

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