Comparative Pharmacokinetics of Two Fast-Dissolving Oral Ibuprofen Formulations and a Regular-Release Ibuprofen Tablet in Healthy Volunteers
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- Schettler, T., Paris, S., Pellett, M. et al. Clin. Drug Investig. (2001) 21: 73. doi:10.2165/00044011-200121010-00010
Spalt-Liqua® is a new soft gelatin capsule containing 200mg of totally dissolved ibuprofen as the active ingredient. The primary objective of the study was to assess bioequivalence between the new ibuprofen formulation 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 of each type of capsule or tablet) was administered to 26 healthy male volunteers in a nonblind, randomised, three-way crossover study with a 6-day washout interval between each drug administration period.
Main Outcome Measures and Results
For the soft gelatin capsules, maximum concentration (Cmax) was significantly greater and time to reach maximum concentration (tmax) was significantly shorter in comparison with the reference tablet formulation, and therefore bioequivalence for these parameters could not be confirmed. However, the shorter absorption time and higher peak 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 logarithmically transformed Cmax and areas under the drug concentration-time curve from zero to the time of the last measurable concentration (AUCt) and to infinity (AUC∞) were within the required bioequivalence range. The three formulations were well tolerated and no clinically significant adverse events were observed.
In accordance with previous results, this study confirmed the pharmacokinetic differences between a standard ibuprofen tablet formulation and fast-dissolving formulations.