BACKGROUND: A new formulation of lansoprazole, the lansoprazole orally disintegrating tablet, rapidly disintegrates in water eliminating the need for swallowing whole pills. AIM: To assess the effect that dispersing the lansoprazole orally disintegrating tablet in water would have on lansoprazole pharmacokinetics. METHODS:Forty healthy adult men and women (18-43 years) received two single 15 mg lansoprazole orally disintegrating tablet doses separated by 3 days (one administered directly onto the tongue without water and one dispersed in water and administered orally via syringe) in a randomized, crossover fashion. Serial plasma samples were determined from 0 to 12 h for each dose. Ratios of central values for peak plasma exposure (C(max)) and mean overall extent of exposure (area under the plasma concentration) were used to compare the bioavailability. RESULTS: The two dosing regimens were bioequivalent, with the point estimate for area under the plasma concentration equalling 1.080 (confidence interval 1.012-1.152) and the point estimate for C(max) equalling 1.082 (confidence interval 0.961-1.218). CONCLUSIONS: Dispersing the 15 mg lansoprazole orally disintegrating tablet in water and administering the dose orally via syringe is bioequivalent to the 15 mg intact lansoprazole orally disintegrating tablet with respect to lansoprazole area under the plasma concentration and C(max). This dosing route provides an additional, convenient dosing option for lansoprazole.
RCT Entities:
BACKGROUND: A new formulation of lansoprazole, the lansoprazole orally disintegrating tablet, rapidly disintegrates in water eliminating the need for swallowing whole pills. AIM: To assess the effect that dispersing the lansoprazole orally disintegrating tablet in water would have on lansoprazole pharmacokinetics. METHODS: Forty healthy adult men and women (18-43 years) received two single 15 mg lansoprazole orally disintegrating tablet doses separated by 3 days (one administered directly onto the tongue without water and one dispersed in water and administered orally via syringe) in a randomized, crossover fashion. Serial plasma samples were determined from 0 to 12 h for each dose. Ratios of central values for peak plasma exposure (C(max)) and mean overall extent of exposure (area under the plasma concentration) were used to compare the bioavailability. RESULTS: The two dosing regimens were bioequivalent, with the point estimate for area under the plasma concentration equalling 1.080 (confidence interval 1.012-1.152) and the point estimate for C(max) equalling 1.082 (confidence interval 0.961-1.218). CONCLUSIONS: Dispersing the 15 mg lansoprazole orally disintegrating tablet in water and administering the dose orally via syringe is bioequivalent to the 15 mg intact lansoprazole orally disintegrating tablet with respect to lansoprazole area under the plasma concentration and C(max). This dosing route provides an additional, convenient dosing option for lansoprazole.