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Inter- and intra-subject variability in gabapentin absorption and absolute bioavailability.

B E Gidal1, L L Radulovic, S Kruger

  • 1Department of Neurology, School of Pharmacy, University of Wisconsin, 425 N. Charter Street, Madison, WI 53706, USA. begidal@pharmacy.wisc.edu

Epilepsy Research
|June 23, 2000
PubMed
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Gabapentin absorption shows greater variability between individuals than within individuals. This suggests that monitoring gabapentin levels in a patient

Area of Science:

  • Pharmacokinetics and Drug Metabolism
  • Clinical Pharmacology
  • Antiepileptic Drug Development

Background:

  • Gabapentin (GBP) is an antiepileptic drug known for its dose-dependent absorption.
  • Active absorption occurs via the system L amino acid transporter.
  • Previous research indicates variability in gabapentin absorption.

Purpose of the Study:

  • To quantify the inter- and intra-subject variability of gabapentin absorption.
  • To assess the implications of this variability for clinical practice and drug monitoring.

Main Methods:

  • Two prospective clinical studies were conducted in healthy adult volunteers.
  • Study A involved a 400-mg single dose, assessing bioavailability of four formulations using plasma concentration-time curves (AUC).

Related Experiment Videos

  • Study B utilized a 600-mg single dose, measuring urinary and plasma gabapentin concentrations to determine bioavailability (F).

    • Main Results:

    • Study A reported an inter-subject coefficient of variation (CV) for AUC of 22.5% and an intra-subject CV of 12.1%.
    • Study B found an inter-subject CV for gabapentin bioavailability (F) of 27.6%.
    • Both studies utilized HPLC-UV for accurate drug concentration measurements.

    Conclusions:

    • Gabapentin absorption exhibits significantly lower variability within subjects compared to between subjects.
    • The substantial inter-subject variability suggests a wide range of absorption across different individuals.
    • The low intra-subject variability supports the utility of plasma drug monitoring for individualizing gabapentin dosage.