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Ibuprofen lysinate, quicker and less variable: relative bioavailability compared to ibuprofen base in a pediatric

Juan Manuel Ferrero-Cafiero, Ignasi Gich, Montse Puntes

    International Journal of Clinical Pharmacology and Therapeutics
    |August 8, 2015
    PubMed

    Insights

    Ibuprofen lysinate suspension offers faster absorption and higher bioavailability for the R-enantiomer compared to ibuprofen base suspension. This suggests ibuprofen lysinate may provide a quicker analgesic and antipyretic effect in pediatric patients.

    Area of Science:

    • Pharmacokinetics and Drug Bioavailability
    • Pediatric Pharmacology
    • Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

    Background:

    • Ibuprofen is a widely used NSAID for pain and fever relief in children.
    • Different formulations, such as ibuprofen lysinate and ibuprofen base, exist, potentially affecting drug absorption and efficacy.
    • Understanding the comparative bioavailability of enantiomers is crucial for optimizing therapeutic outcomes.

    Purpose of the Study:

    • To compare the bioavailability of ibuprofen enantiomers (R and S) between two pediatric suspension formulations: ibuprofen lysinate (Algidrin® Pediátrico) and ibuprofen base (Dalsy®).
    • To assess differences in the rate and variability of absorption between the two formulations.

    Main Methods:

    • A randomized, open-label, single-dose, balanced, crossover study involving 24 healthy adult volunteers under fasting conditions.
    • Participants received equivalent 400 mg doses of ibuprofen lysinate and ibuprofen base suspensions.
    • Plasma concentrations of ibuprofen enantiomers were measured using an enantioselective analytical method, with pharmacokinetic parameters analyzed via ANOVA.

    Main Results:

    • S-ibuprofen showed similar Cmax and AUC values between the two formulations.
    • R-ibuprofen exhibited significantly higher Cmax and AUC values (indicating suprabioavailability) for the ibuprofen lysinate formulation compared to ibuprofen base.
    • The ibuprofen lysinate suspension demonstrated a quicker (shorter tmax) and less variable absorption rate for both enantiomers compared to the ibuprofen base suspension.

    Conclusions:

    • Ibuprofen lysinate formulation demonstrates suprabioavailability for the R-enantiomer and a faster rate of absorption compared to ibuprofen base.
    • The quicker absorption and shorter tmax of ibuprofen lysinate are advantageous for achieving rapid and consistent analgesic and antipyretic effects.
    • Further studies are warranted to confirm these findings in the pediatric population and under fed conditions.
    Abstract

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