title: Lansoprazole: an alternative method of administration of a capsule dosage formulation.
abstract: A single-dose, open-label, randomized, fasting, two-period, crossover bioavailability study was conducted in 24 healthy adult men to assess an alternative method of administration of lansoprazole capsules. Half of the subjects received regimen A (contents from a 30-mg capsule placed in a tablespoonful of applesauce), and the other half received regimen B (an intact 30-mg capsule) during period 1 of the crossover study. The regimens were reversed during the second period 1 week later. Blood samples were obtained over 12 hours and pharmacokinetic parameters were determined. Mean time elapsed to peak concentration (Tmax) was less than 2 hours for each regimen. The ratio (regimen A:regimen B) of peak concentration (Cmax) means and area under the curve (AUC)0-infinity means were 0.889 and 0.944, respectively. (AUC0-infinity is the sum of AUC0-t and AUCt-infinity, where AUC0-t is the area under the plasma concentration-time curve from time 0 to the time of the last measurable or nonzero concentration as computed by using the trapezoidal rule, and AUCt-infinity is computed as the last nonzero concentration divided by the terminal phase rate constant.) No statistically significant differences (P < or = 0.05) in Tmax, Cmax, and AUC0-infinity were detected between regimens. These data indicate similar bioavailabilities between the two regimens. Lansoprazole granules contained in a standard capsule dosage formulation may be removed and placed directly into applesauce and administered to appropriate patients.
authors.affiliation: Abbott Laboratories, Pharmaceutical Products Division, Abbott Park, Illinois, USA.
authors.forename: A H
authors.initials: AH
authors.lastname: Chun
authors.forename: C J
authors.initials: CJ
authors.lastname: Eason
authors.forename: H H
authors.initials: HH
authors.lastname: Shi
authors.forename: J H
authors.initials: JH
authors.lastname: Cavanaugh
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D001682:Biological Availability; D002214:Capsules; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D002214:Capsules; D064747:Lansoprazole; D009853:Omeprazole