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Relative bioavailability of bedaquiline tablets suspended in water: Implications for dosing in children

Elin M Svensson1,2, Jeannine du Bois3, Rene Kitshoff3

  • 1Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.

British Journal of Clinical Pharmacology
|June 29, 2018
PubMed

Insights

Suspending bedaquiline tablets in water is bioequivalent to whole tablets and well-tolerated. This approach may enable pediatric use of bedaquiline for multidrug-resistant tuberculosis treatment.

Area of Science:

  • Pharmacology
  • Clinical Pharmacy
  • Tuberculosis Research

Background:

  • Bedaquiline is a critical drug for multidrug-resistant tuberculosis (MDR-TB).
  • No pediatric formulation of bedaquiline currently exists.
  • Existing adult tablet formulations require evaluation for pediatric use.

Purpose of the Study:

  • To assess the relative bioavailability of suspended bedaquiline tablets versus whole tablets.
  • To evaluate the short-term safety, acceptability, and palatability of suspended bedaquiline.
  • To determine the feasibility of using the current bedaquiline tablet formulation in pediatric patients.

Main Methods:

  • A randomized, open-label, two-period cross-over study in 24 healthy adult volunteers.
  • Pharmacokinetic sampling over 48 hours after administration of 400 mg bedaquiline (whole or suspended).
  • Nonlinear mixed-effects modeling for pharmacokinetic analysis; questionnaire for acceptability and palatability.

Main Results:

  • No statistically significant difference in bioavailability between suspended and whole bedaquiline tablets.
  • Relative bioavailability of suspended tablets was 94-108% of whole tablets, meeting bioequivalence criteria.
  • No serious adverse events; suspension showed no apparent differences in taste, texture, or smell compared to whole tablets.

Conclusions:

  • Bedaquiline tablets suspended in water demonstrate equivalent bioavailability to whole tablets.
  • The suspension form was well-tolerated, suggesting suitability for pediatric use.
  • This finding can bridge the gap until a dedicated pediatric formulation of bedaquiline is available for MDR-TB treatment.
Abstract

Keywords:
bedaquilinebioavailabilitypaediatric dosingpopulation PKsuspended tablets

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