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Bioavailability of two licensed paediatric rifampicin suspensions: implications for quality control programmes

H McIlleron1, H Hundt1, W Smythe2

  • 1Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.

The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease
|June 12, 2016
PubMed

Insights

Two rifampicin (RMP) oral suspensions showed significant differences in bioavailability for treating childhood tuberculosis (TB). Ensuring RMP suspension quality is critical for effective pediatric TB treatment.

Area of Science:

  • Pharmacology
  • Pediatric Infectious Diseases
  • Tuberculosis Treatment

Background:

  • Rifampicin (RMP) is a cornerstone medication for tuberculosis (TB) treatment.
  • Accurate dosing and consistent bioavailability are crucial for effective pediatric TB therapy.
  • The World Health Organization recommends a revised RMP dose of 10-20 mg/kg for children.

Purpose of the Study:

  • To assess the steady-state pharmacokinetics of rifampicin (RMP) in South African children.
  • To evaluate the impact of different RMP oral suspension formulations on drug bioavailability.
  • To inform optimal RMP dosing strategies for pediatric tuberculosis treatment.

Main Methods:

  • Pharmacokinetic analysis of RMP plasma concentrations in 146 children with drug-susceptible TB.
  • Administration of two different RMP single-drug oral suspension formulations.
  • Comparison of 2-hour post-dose RMP concentrations between formulations and with adult data.

Main Results:

  • Significant variability in RMP bioavailability was observed between the two tested oral suspension formulations.
  • One formulation achieved RMP concentrations comparable to adult levels, while the other showed substantially lower bioavailability (median 25%).
  • Median 2-hour RMP concentrations were 6.54 mg/l for the adequate formulation and 1.59 mg/l for the suboptimal one.

Conclusions:

  • The formulation of rifampicin oral suspensions critically impacts drug bioavailability in children.
  • Ensuring the quality and consistent bioavailability of RMP suspensions is essential for successful childhood TB treatment.
  • Further research and quality control are needed for pediatric RMP formulations.
Abstract

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