LANSOPRAZOLE - AN ALTERNATIVE METHOD OF ADMINISTRATION OF A CAPSULE DOSAGE FORMULATION

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 (T-max) was less than 2 hours for each regimen. The ratio (regimen A:regimen B) of peak concentration (C-max) means and area under the curve (AUC)(0-infinity) means were 0.889 and 0.944, respectively. (AUC(0-infinity) is the sum of AUG(0-t) and AUG(t-infinity) where AUG(0-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 AUC(t-infinity) is computed as the last nonzero concentration divided by the terminal phase rate constant.) No statistically significant differences (P less than or equal to 0.05) in T-max, C-max, and AUC(0-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.