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Paediatric formulations of second-line anti-tuberculosis medications: challenges and considerations
R Taneja1, A J Garcia-Prats2, J Furin2
1The Global Alliance for TB Drug Development, New York, New York, USA.
Insights
Developing child-friendly dispersible tablets for multidrug-resistant tuberculosis (TB) is crucial. These formulations improve drug accessibility and adherence in children, combating treatment failure and the spread of resistant TB.
Area of Science:
- Paediatric pharmacology
- Infectious diseases
- Pharmaceutical development
Background:
- Increasing global access to second-line anti-tuberculosis (TB) drugs for multidrug-resistant TB in children.
- Lack of child-friendly drug formulations, particularly dispersible tablets, for paediatric TB treatment.
- Dispersible tablets offer advantages in stability, shelf-life, cost, and adherence for paediatric TB management.
Purpose of the Study:
- To highlight the need for child-friendly second-line anti-TB drug formulations.
- To discuss challenges in developing dispersible tablet formulations for paediatric use.
- To propose strategies for overcoming development obstacles and advocating for paediatric considerations in new drug development.
Main Methods:
- Literature review and discussion of current challenges in paediatric TB drug formulation.
- Analysis of the advantages of dispersible tablets for paediatric anti-TB treatment.
- Exploration of strategies to facilitate the development of child-friendly TB medications.
Main Results:
- No second-line anti-TB drugs are currently available in dispersible formulations for children.
- Significant obstacles exist in developing these essential paediatric formulations.
- Dispersible tablets offer a viable solution for improving drug stability, affordability, and adherence in paediatric TB treatment.
Conclusions:
- There is an urgent need for the development of child-friendly dispersible tablets for second-line anti-TB drugs.
- Addressing formulation challenges and advocating for early paediatric consideration in drug development are critical.
- Improved formulations will enhance treatment adherence, reduce treatment failure, and mitigate the spread of drug-resistant TB in children.
Abstract:
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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