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Related Experiment Videos

Comparative bioavailability study of two controlled-release pentoxifylline tablet preparations.

K H Yuen1, J W Wong, K K Peh

  • 1School of Pharmaceutical Sciences, University of Science Malaysia, Penang, Malaysia. khyuen@usm.my

Drug Development and Industrial Pharmacy
|June 29, 2000
PubMed
Summary

This study found that a generic pentoxifylline sustained-release tablet is bioequivalent to the branded version, Trental 400. Bioavailability parameters showed no significant differences, indicating comparable efficacy for both pentoxifylline preparations.

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Area of Science:

  • Pharmacokinetics
  • Pharmaceutical Sciences
  • Drug Bioavailability

Background:

  • Pentoxifylline is a hemorheologic agent used to improve blood flow.
  • Sustained-release (SR) formulations enhance drug delivery and patient compliance.
  • Evaluating the bioavailability of generic drugs is crucial for therapeutic equivalence.

Purpose of the Study:

  • To assess the bioavailability of a generic pentoxifylline SR tablet.
  • To compare its pharmacokinetic profile against the proprietary product, Trental 400.
  • To determine therapeutic equivalence between the generic and branded pentoxifylline formulations.

Main Methods:

  • A randomized, two-way crossover study involving 12 healthy male volunteers.
  • Bioavailability assessment using key pharmacokinetic parameters: AUC0-infinity, Cmax, and Tmax.

Related Experiment Videos

  • Calculation of elimination half-life (t1/2) and apparent volume of distribution (Vd).

    • Main Results:

    • No statistically significant differences were observed in AUC0-infinity, Cmax, or Tmax between the generic and Trental 400.
    • The 90% confidence intervals for AUC0-infinity ratio (0.83-1.00) and Cmax ratio (0.91-1.29) fell within acceptable bioequivalence ranges.
    • No significant differences were found in t1/2 and Vd values.

    Conclusions:

    • The generic pentoxifylline SR tablet demonstrates comparable bioavailability to Trental 400.
    • The study supports the therapeutic equivalence of the generic pentoxifylline formulation.
    • This finding has implications for cost-effective treatment options with pentoxifylline.