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 (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−∞ means were 0.889 and 0.944, respectively. (AUC 0−∞ is the sum of AUC 0−t and AUC t−∞ , where AUC 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−∞ is computed as the last nonzero concentration divided by the terminal phase rate constant.) No statistically significant differences ( P ≤ 0.05) in T max , C max , and AUC 0−∞ 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.