ArticlePloS one2014
Isoniazid, pyrazinamide and rifampicin content variation in split fixed-dose combination tablets.
Article in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
12 citing papers in PubMed.
- Estimating the prevalence of poor-quality anti-TB medicines: a neglected risk for global TB control and resistance.BMJ global health · 2023Article
- A pharmaceutical monitoring system to assess the quality of antituberculosis drug products used in Mauritania.PloS one · 2023Article
- Real-life isoniazid and rifampicin plasma concentrations in children: a tool for therapeutic drug monitoring of tuberculosis.BMC infectious diseases · 2021Article
- Independent Tailoring of Dose and Drug Release via a Modularized Product Design Concept for Mass Customization.Pharmaceutics · 2020Article
- Optimal Design, Characterization and Preliminary Safety Evaluation of an Edible Orodispersible Formulation for Pediatric Tuberculosis Pharmacotherapy.International journal of molecular sciences · 2020Article
- Development and Evaluation of a Reconstitutable Dry Suspension Containing Isoniazid for Flexible Pediatric Dosing.Pharmaceutics · 2020Article
- Tablet Splitting of Antiepileptic Drugs in Pediatric Epilepsy: Potential Effect on Plasma Drug Concentrations.Paediatric drugs · 2016Article
- Emergence of 3D Printed Dosage Forms: Opportunities and Challenges.Pharmaceutical research · 2016Review
- Ethical challenges in designing and conducting medicine quality surveys.Tropical medicine & international health : TM & IH · 2016Article
- Naïve-pooled pharmacokinetic analysis of pyrazinamide, isoniazid and rifampicin in plasma and cerebrospinal fluid of Vietnamese children with tuberculous meningitis.BMC infectious diseases · 2016Article
- Leprosy among children under 15 years of age: literature review.Anais brasileiros de dermatologia · 2016Review
- Orally disintegrating films and mini-tablets-innovative dosage forms of choice for pediatric use.AAPS PharmSciTech · 2015Review
Corrections and comments
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Authors and funding
5 authors.
Funding
Abstract
settingIn most developing countries, paediatric tuberculosis is treated with split tablets leading to potential inaccuracy in the dose delivery and drug exposure. There is no data on the quality of first-line drugs content in split fixed-dose combination tablets.
objectiveTo determine Isoniazid, Pyrazinamide and Rifampicin content uniformity in split FDC tablets used in the treatment of childhood tuberculosis.
designDrug contents of 15 whole tablets, 30 half tablets and 36 third tablets were analysed by high performance liquid chromatography. The content uniformity was assessed by comparing drug content measured in split portions with their expected amounts and the quality of split portions was assessed applying qualitative specifications for whole tablets.
resultsAll whole tablets measurements fell into the USP proxy for the three drugs. But a significant number of half and third portions was found outside the tolerated variation range and the split formulation failed the requirements for content uniformity. To correct for the inaccuracy of splitting the tablets into equal portions, a weight-adjustment strategy was used but this did not improve the findings.
conclusionIn split tablets the content of the three drugs is non-uniform and exceeded the USP recommendations. There is an absolute need to make child-friendly formulations available for the treatment of childhood tuberculosis.
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Registered trials
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