Literature DB >> 27287644

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

H McIlleron1, H Hundt1, W Smythe2, A Bekker3, J Winckler4, L van der Laan3, P Smith1, H J Zar5, A C Hesseling3, G Maartens1, L Wiesner1, A van Rie6.   

Abstract

SETTING: To assess the revised World Health Organization-recommended dose of 10-20 mg/kg rifampicin (RMP), we studied the steady state pharmacokinetics of RMP in South African children who received standard treatment for drug-susceptible tuberculosis (TB).
OBJECTIVE: To determine the formulation effect on the pharmacokinetics of RMP.
DESIGN: RMP plasma concentrations were characterised in 146 children (median age 1.4 years, range 0.2-10.2). The morning dose on the day of the pharmacokinetic evaluation was administered as one of two RMP single-drug oral suspensions.
RESULTS: While one formulation achieved 2 h concentrations in the range of those observed in adults (median 6.54 mg/l, interquartile range [IQR] 4.47-8.84), the other attained a median bioavailability of only 25% of this, with a median 2 h concentration of 1.59 mg/l (IQR 0.89-2.38).
CONCLUSION: RMP is a key drug for the treatment of TB. It is critical that the quality of RMP suspensions used to treat childhood TB is ensured.

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Year:  2016        PMID: 27287644      PMCID: PMC4978631          DOI: 10.5588/ijtld.15.0833

Source DB:  PubMed          Journal:  Int J Tuberc Lung Dis        ISSN: 1027-3719            Impact factor:   2.373


  15 in total

1.  Widespread distribution of a single drug rifampicin formulation of inferior bioavailability in South Africa.

Authors:  H McIlleron; P Wash; A Burger; P Folb; P Smith
Journal:  Int J Tuberc Lung Dis       Date:  2002-04       Impact factor: 2.373

2.  Solid-state characterization of rifampicin samples and its biopharmaceutic relevance.

Authors:  Shrutidevi Agrawal; Yasvanth Ashokraj; Prasad V Bharatam; Omathanu Pillai; Ramesh Panchagnula
Journal:  Eur J Pharm Sci       Date:  2004-06       Impact factor: 4.384

Review 3.  The pharmacokinetics and pharmacodynamics of rifampicin in adults and children in relation to the dosage recommended for children.

Authors:  P R Donald; J S Maritz; A H Diacon
Journal:  Tuberculosis (Edinb)       Date:  2011-03-22       Impact factor: 3.131

Review 4.  Therapeutic drug monitoring in the treatment of tuberculosis: an update.

Authors:  Abdullah Alsultan; Charles A Peloquin
Journal:  Drugs       Date:  2014-06       Impact factor: 9.546

5.  Randomised controlled trials in child health in developing countries: trends and lessons over 11 years.

Authors:  Trevor Duke; David Fuller
Journal:  Arch Dis Child       Date:  2014-03-10       Impact factor: 3.791

6.  Determinants of rifampin, isoniazid, pyrazinamide, and ethambutol pharmacokinetics in a cohort of tuberculosis patients.

Authors:  Helen McIlleron; Peter Wash; André Burger; Jennifer Norman; Peter I Folb; Pete Smith
Journal:  Antimicrob Agents Chemother       Date:  2006-04       Impact factor: 5.191

7.  Characterization of the solubility and dissolution properties of several new rifampicin polymorphs, solvates, and hydrates.

Authors:  S Q Henwood; W Liebenberg; L R Tiedt; A P Lötter; M M de Villiers
Journal:  Drug Dev Ind Pharm       Date:  2001-11       Impact factor: 3.225

8.  Solubility and dissolution properties of generic rifampicin raw materials.

Authors:  S Q Henwood; M M de Villiers; W Liebenberg; A P Lötter
Journal:  Drug Dev Ind Pharm       Date:  2000-04       Impact factor: 3.225

9.  Biowaiver monographs for immediate release solid oral dosage forms: rifampicin.

Authors:  C Becker; J B Dressman; H E Junginger; S Kopp; K K Midha; V P Shah; S Stavchansky; D M Barends
Journal:  J Pharm Sci       Date:  2009-07       Impact factor: 3.534

10.  Low plasma concentrations of rifampicin in tuberculosis patients in Indonesia.

Authors:  R van Crevel; B Alisjahbana; W C M de Lange; F Borst; H Danusantoso; J W M van der Meer; D Burger; R H H Nelwan
Journal:  Int J Tuberc Lung Dis       Date:  2002-06       Impact factor: 2.373

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  12 in total

1.  Noninvasive 11C-rifampin positron emission tomography reveals drug biodistribution in tuberculous meningitis.

Authors:  Elizabeth W Tucker; Beatriz Guglieri-Lopez; Alvaro A Ordonez; Brittaney Ritchie; Mariah H Klunk; Richa Sharma; Yong S Chang; Julian Sanchez-Bautista; Sarah Frey; Martin A Lodge; Steven P Rowe; Daniel P Holt; Jogarao V S Gobburu; Charles A Peloquin; William B Mathews; Robert F Dannals; Carlos A Pardo; Sujatha Kannan; Vijay D Ivaturi; Sanjay K Jain
Journal:  Sci Transl Med       Date:  2018-12-05       Impact factor: 17.956

2.  Pharmacokinetics of First-Line Drugs Among Children With Tuberculosis in Rural Tanzania.

Authors:  Museveni Justine; Anita Yeconia; Ingi Nicodemu; Domitila Augustino; Jean Gratz; Estomih Mduma; Scott K Heysell; Sokoine Kivuyo; Sayoki Mfinanga; Charles A Peloquin; Theodore Zagurski; Gibson S Kibiki; Blandina Mmbaga; Eric R Houpt; Tania A Thomas
Journal:  J Pediatric Infect Dis Soc       Date:  2020-02-28       Impact factor: 3.164

3.  Optimizing Dosing and Fixed-Dose Combinations of Rifampicin, Isoniazid, and Pyrazinamide in Pediatric Patients With Tuberculosis: A Prospective Population Pharmacokinetic Study.

Authors:  Paolo Denti; Roeland E Wasmann; Annelies van Rie; Jana Winckler; Adrie Bekker; Helena Rabie; Anneke C Hesseling; Louvina E van der Laan; Carmen Gonzalez-Martinez; Heather J Zar; Gerry Davies; Lubbe Wiesner; Elin M Svensson; Helen M McIlleron
Journal:  Clin Infect Dis       Date:  2022-08-24       Impact factor: 20.999

4.  Pharmacokinetics of Rifampin, Isoniazid, Pyrazinamide, and Ethambutol in Infants Dosed According to Revised WHO-Recommended Treatment Guidelines.

Authors:  A Bekker; H S Schaaf; H R Draper; L van der Laan; S Murray; L Wiesner; P R Donald; H M McIlleron; A C Hesseling
Journal:  Antimicrob Agents Chemother       Date:  2016-03-25       Impact factor: 5.191

5.  Population Pharmacokinetics and Dosing of Ethionamide in Children with Tuberculosis.

Authors:  Henrik Bjugård Nyberg; Heather R Draper; Anthony J Garcia-Prats; Stephanie Thee; Adrie Bekker; Heather J Zar; Andrew C Hooker; H Simon Schaaf; Helen McIlleron; Anneke C Hesseling; Paolo Denti
Journal:  Antimicrob Agents Chemother       Date:  2020-02-21       Impact factor: 5.938

6.  Pharmacokinetics and safety of high-dose rifampicin in children with TB: the Opti-Rif trial.

Authors:  Anthony J Garcia-Prats; Elin M Svensson; Jana Winckler; Heather R Draper; Lee Fairlie; Louvina E van der Laan; Masebole Masenya; H Simon Schaaf; Lubbe Wiesner; Jennifer Norman; Rob E Aarnoutse; Mats O Karlsson; Paolo Denti; Anneke C Hesseling
Journal:  J Antimicrob Chemother       Date:  2021-11-12       Impact factor: 5.758

7.  Quality assurance of rifampicin-containing fixed-drug combinations in South Africa: dosing implications.

Authors:  R Court; M T Chirehwa; L Wiesner; B Wright; W Smythe; N Kramer; H McIlleron
Journal:  Int J Tuberc Lung Dis       Date:  2018-05-01       Impact factor: 2.373

8.  Shorter treatment for minimal tuberculosis (TB) in children (SHINE): a study protocol for a randomised controlled trial.

Authors:  Chishala Chabala; Anna Turkova; Margaret J Thomason; Eric Wobudeya; Syed Hissar; Vidya Mave; Marieke van der Zalm; Megan Palmer; Monica Kapasa; Perumal K Bhavani; Sarath Balaji; Priyanka A Raichur; Anne-Marie Demers; Graeme Hoddinott; Ellen Owen-Powell; Aarti Kinikar; Philippa Musoke; Veronica Mulenga; Rob Aarnoutse; Helen McIlleron; Anneke Hesseling; Angela M Crook; Mark Cotton; Diana M Gibb
Journal:  Trials       Date:  2018-04-19       Impact factor: 2.279

9.  Pharmacokinetics, Safety, and Dosing of Novel Pediatric Levofloxacin Dispersible Tablets in Children with Multidrug-Resistant Tuberculosis Exposure.

Authors:  Paolo Denti; Anneke C Hesseling; Anthony J Garcia-Prats; Susan E Purchase; Muhammad Osman; Heather R Draper; H Simon Schaaf; Lubbe Wiesner
Journal:  Antimicrob Agents Chemother       Date:  2019-03-27       Impact factor: 5.191

Review 10.  Current research toward optimizing dosing of first-line antituberculosis treatment.

Authors:  Helen McIlleron; Maxwell T Chirehwa
Journal:  Expert Rev Anti Infect Ther       Date:  2018-12-12       Impact factor: 5.091

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