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Comparative bioavailability of ceftibuten in capsule and suspension forms
C C Lin1, M Affrime, E Radwanski
1Department of Drug Metabolism and Pharmacokinetics, Schering-Plough Research Institute, Kenilworth, New Jersey, USA.
Clinical Therapeutics
|November 1, 1996
Summary
Ceftibuten, a third-generation cephalosporin antibiotic, demonstrated bioequivalence between its capsule and suspension forms. This confirms that both oral dosage forms deliver the antibiotic effectively for once-daily administration.
Area of Science:
- Pharmacology
- Clinical Pharmacy
- Drug Development
Background:
- Ceftibuten is a novel, third-generation cephalosporin antibiotic.
- Oral administration of antibiotics requires careful consideration of dosage form bioavailability.
- Once-daily dosing regimens are preferred for improved patient compliance.
Purpose of the Study:
- To assess the comparative bioavailability of ceftibuten in capsule and suspension dosage forms.
- To establish bioequivalence between different ceftibuten formulations.
- To support the use of ceftibuten in a once-daily oral regimen.
Main Methods:
- Three separate bioequivalence studies were conducted in healthy male subjects.
- Subjects received varying doses and formulations of ceftibuten (400-mg suspension, 400-mg capsule, two 200-mg capsules).
- Plasma ceftibuten concentrations were measured using high-performance liquid chromatography (HPLC) and analyzed pharmacokinetically.
Main Results:
- Confidence intervals for Cmax and AUC(infinity) were within the 80% to 125% bioequivalence guidelines.
- A 400-mg ceftibuten capsule (laboratory or production batch) was bioequivalent to two 200-mg capsules.
- The 400-mg suspension was bioequivalent to the 400-mg capsule (laboratory batch).
Conclusions:
- Ceftibuten capsules and suspension dosage forms are bioequivalent.
- The findings support the interchangeability of ceftibuten capsule and suspension formulations.
- This study validates the use of ceftibuten in a once-daily oral dosing strategy.