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Open Access Paediatric formulations of second-line anti-tuberculosis medications: challenges and considerations

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There is a growing number of children worldwide accessing second-line anti-tuberculosis drugs for multidrug-resistant tuberculosis (TB); however, there are very few child-friendly formulations. For paediatric use, dispersible tablets offer distinct advantages over liquid formulations and other approaches. This is particularly relevant for TB, where stability, long shelf-life and reduced manufacturing, transport and storage costs are all critical to ensuring that drugs are accessible and affordable. In addition, fixed-dose combinations that reduce the pill burden and provide adequate taste masking may promote long-term adherence to anti-tuberculosis treatment and prevention regimens likely to last many months in children. Partial adherence may result in treatment failure and the further selection and spread of resistant mycobacteria. Unfortunately, no second-line TB paediatric drugs exist in dispersible formulations. We discuss here the main obstacles to developing such tablets and present strategies for overcoming them. We also advocate for timely anticipation of paediatric use when new TB drugs are being developed, and for the development of child-friendly anti-tuberculosis formulations in general.
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Keywords: CMC; FDC; TB; linezolid; rifampicin

Document Type: Research Article

Affiliations: 1: The Global Alliance for TB Drug Development, New York, New York, USA 2: Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa 3: Macleods Pharmaceuticals Ltd, Mumbai, India

Publication date: 01 December 2015

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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.

    Certain IJTLD articles are selected for translation into French, Spanish, Chinese or Russian. They are available on the Union website

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