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Bioavailability and pharmacokinetics of acyclovir tablet preparation
1School of Pharmaceutical Sciences, University of Science Malaysia 11800 Penang, Malaysia.
Drug Development and Industrial Pharmacy
|December 21, 2004
Summary
This study compared the bioavailability of generic acyclovir (Avorax) to Zovirax. Results show Avorax is bioequivalent to Zovirax, indicating comparable efficacy and safety.
Area of Science:
- Pharmacokinetics
- Drug Bioavailability
- Generic Drug Equivalence
Background:
- Generic medications offer potential cost savings.
- Ensuring bioequivalence is crucial for therapeutic interchangeability.
- Acyclovir is a key antiviral medication.
Purpose of the Study:
- To assess the bioequivalence of a generic acyclovir preparation (Avorax) compared to the innovator product (Zovirax).
- To evaluate key pharmacokinetic parameters between the two acyclovir formulations.
Main Methods:
- A randomized, two-way crossover study involving 12 healthy volunteers.
- Comparison of area under the plasma concentration-time curve (AUC(0-infinity)), peak plasma concentration (Cmax), and time to peak concentration (Tmax).
- Statistical analysis of pharmacokinetic parameters and 90% confidence intervals for equivalence.
Main Results:
- No statistically significant differences were found in Tmax, AUC(0-infinity), or Cmax between Avorax and Zovirax.
- The 90% confidence intervals for the ratios of AUC(0-infinity) (0.85-1.06) and Cmax (0.95-1.25) fell within the bioequivalence range (0.80-1.25).
- Elimination rate constant, half-life, and volume of distribution were comparable between the two preparations.
Conclusions:
- The generic acyclovir preparation, Avorax, is bioequivalent to the innovator product, Zovirax.
- This supports the therapeutic interchangeability of Avorax for Zovirax.
- The findings validate the quality and performance of the generic acyclovir formulation.