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Bioavailability of cefuroxime axetil formulations
K H Donn1, N C James, J R Powell
1Glaxo Inc., Research Triangle Park, NC 27709, USA.
Journal of Pharmaceutical Sciences
|June 1, 1994
Summary
Cefuroxime axetil suspension and tablet formulations were not bioequivalent in healthy adults. Adding sodium lauryl sulfate (SLS) to the suspension did not improve bioequivalence with the tablet form.
Area of Science:
- Pharmacology
- Drug Development
Background:
- Cefuroxime axetil is effective for community-acquired infections.
- Pediatric suspension formulation developed.
- Bioequivalence studies needed for cefuroxime axetil formulations.
Purpose of the Study:
- To assess bioequivalence between cefuroxime axetil suspension and tablet formulations.
- To evaluate the impact of sodium lauryl sulfate (SLS) on suspension bioavailability.
Main Methods:
- Two randomized, crossover bioequivalence studies in healthy adult males.
- Administration of 250-mg cefuroxime axetil doses (suspension and tablet).
- Pharmacokinetic analysis of serum and urine parameters.
Main Results:
- Initial study: Cefuroxime axetil suspension and tablet were not bioequivalent.
- Second study: Suspension with SLS and without SLS were bioequivalent.
- Second study: Suspension with SLS and tablet were not bioequivalent.
Conclusions:
- Cefuroxime axetil suspension and tablet formulations are not bioequivalent.
- Sodium lauryl sulfate addition did not establish bioequivalence between suspension and tablet.