Paper
Ibuprofen Sodium Is Absorbed Faster than Standard Ibuprofen Tablets: Results of Two Open-Label, Randomized, Crossover Pharmacokinetic Studies
Published Nov 14, 2014 · T. Legg, A. Laurent, R. Leyva
Drugs in R&D
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Influential Citations
Abstract
BackgroundA novel ibuprofen (IBU) formulation, Advil^® Film-Coated Tablets (IBU_Na), was developed.ObjectivePharmacokinetic comparison of IBU_Na versus other IBU formulations.Study DesignTwo randomized, single-dose, open-label, five-way crossover pharmacokinetic studies.SettingInpatient research clinic.SubjectsSeventy-one healthy adult volunteers.InterventionStudy 1: In three periods, fasted subjects received 400-mg IBU dose equivalents as IBU_Na 2 × 256 mg, Advil^® Liqui-Gels^® (IBU_LG) 2 × 200 mg, and Motrin^® IB (IBU_Mot) 2 × 200 mg tablets. In two periods following a high-fat breakfast, subjects received 400-mg IBU dose equivalents as IBU_Na 2 × 256 mg and IBU_LG 2 × 200 mg. Study 2: In five study periods, fasted subjects received 400-mg IBU dose equivalents as IBU_Na 2 × 256 mg, Advil^® FastGel^® (IBU_FG) 2 × 200 mg, Nurofen^® (IBU_Nur) 2 × 200 mg, Advil^® (IBU_Adv) 2 × 200 mg, and Nurofen^® Express containing IBU lysinate (IBU_Lys) 2 × 342 mg.Main Outcome MeasureLog-transformed area under the plasma concentration versus time curve to last observable concentration (AUC_L) and maximum plasma concentration (C _max) were the primary pharmacokinetic parameters; time to maximum measured plasma concentration (T _max) was analyzed post hoc.ResultsIBU_Na was bioequivalent to IBU_LG (fasted and fed) and IBU_FG and IBU_Lys (fasted) for rate (C _max) and extent (AUC_L) of IBU absorption. After fasting, AUC_L was bioequivalent for IBU_Na and IBU_Mot, IBU_Adv, and IBU_Nur, but C _max occurred significantly earlier with IBU_Na. After fasting, median IBU_Na T _max was comparable to that for IBU_LG, IBU_FG, and IBU_Lys, but was much shorter than that for IBU_Mot, IBU_Nur, and IBU_Adv. Food slowed absorption of IBU_Na and IBU_LG similarly. All treatments were tolerated similarly.ConclusionIBU_Na is absorbed faster but to a similar extent as standard IBU formulations.
RCT
Rigorous JournalIBUNa is absorbed faster but to a similar extent as standard ibuprofen formulations, making it a promising alternative for patients with fasted or fed conditions.
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