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Related Experiment Videos

Comparative bioavailability study of cefixime administered as tablets or aqueous solution.

G Montay1, F Masala, Y Le Roux

  • 1Rhône-Poulenc Rorer, Antony, France.

Drugs
|January 1, 1991
PubMed
Summary

Cefixime bioavailability was compared between an aqueous solution and tablets. The 400mg and 2x200mg cefixime tablets demonstrated bioequivalence, supporting a once-daily dosage regimen.

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Area of Science:

  • Pharmacokinetics
  • Drug bioavailability studies
  • Clinical pharmacology

Background:

  • Cefixime is a third-generation cephalosporin antibiotic used to treat various bacterial infections.
  • Understanding cefixime's bioavailability is crucial for optimizing dosage regimens and ensuring therapeutic efficacy.
  • Different formulations may impact drug absorption and pharmacokinetic profiles.

Purpose of the Study:

  • To compare the relative bioavailability of cefixime administered as an aqueous solution versus tablet formulations.
  • To assess the bioequivalence between a single 400mg cefixime tablet and two 200mg cefixime tablets.
  • To evaluate the pharmacokinetic profile of the 400mg cefixime tablet to support a once-daily dosing strategy.

Main Methods:

  • A randomized crossover study involving 24 healthy male volunteers.

Related Experiment Videos

  • Administration of a single 400mg dose of cefixime in three forms: aqueous solution, 400mg tablet, and two 200mg tablets.
  • Serum and urine sample analysis using high-performance liquid chromatography (HPLC).

    • Main Results:

    • Peak cefixime plasma levels were reached at 3 hours for the solution and 4 hours for the tablets.
    • The extent of absorption was marginally improved with the solution (14% and 7% higher than 400mg and 2x200mg tablets, respectively).
    • The 400mg and 2x200mg cefixime tablets were found to be bioequivalent.
    • The 400mg tablet exhibited a mean maximum plasma concentration of 4.4 mg/L, an area under the curve of 34.4 mg/L·h, and a half-life of 3.7 hours.

    Conclusions:

    • The 400mg and 2x200mg cefixime tablet formulations are bioequivalent.
    • The pharmacokinetic profile of the 400mg cefixime tablet supports its use in a 400mg once-daily dosage regimen.
    • The study provides evidence for the clinical utility of a once-daily cefixime dosing regimen using tablet formulations.