Comparative pharmacokinetics of two fast-dissolving oral ibuprofen formulations and a regular-release ibuprofen tablet in healthy volunteers

Objective: Spalt-Liqua(R) is a new soft gelatin capsule containing 200mg of totally dissolved ibuprofen as the active ingredient. The primary objectiv e of the study was to assess bioequivalence between the new ibuprofen formu lation and the standard 200mg sugar-coated tablets. The secondary objective was to assess bioequivalence between the new formulation and 200mg tablets of a fast-dissolving ibuprofen lysinate formulation. Design and Study Participants: A single oral dose of ibuprofen 400mg (two o f each type of capsule or tablet) was administered to 26 healthy male volun teers in a nonblind, randomised, three-way crossover study with a 6-day was hout interval between each drug administration period. Main Outcome Measures and Results: For the soft gelatin capsules, maximum c oncentration (C-max) was significantly greater and time to reach maximum co ncentration (t(max)) was significantly shorter in comparison with the refer ence tablet formulation, and therefore bioequivalence for these parameters could not be confirmed. However, the shorter absorption time and higher pea k plasma concentration did not affect the extent of absorption of the soft gelatin capsule. In contrast to this result, the pharmacokinetic profile of the soft gelatin capsules was very similar to that of the fast-dissolving ibuprofen lysinate tablets. The 90% confidence intervals for logarithmicall y transformed Cmax and areas under the drug concentration-time curve from z ero to the time of the last measurable concentration (AUC(t)) and to infini ty (AUC(infinity)) were within the required bioequivalence range. The three formulations were well tolerated and no clinically significant adverse eve nts were observed. Conclusions: In accordance with previous results, this study confirmed the pharmacokinetic differences between a standard ibuprofen tablet formulation and fast-dissolving formulations.