02402nas a2200289 4500000000100000008004100001260004400042653002400086653001700110653002700127653004400154653003900198653002100237653003300258100001600291700001300307700001400320700001200334700001400346700001700360245011200377856009300489300000900582490000700591520150000598022001402098 2022 d bSpringer Science and Business Media LLC10aInfectious Diseases10aParasitology10aPaediatric indications10aPaediatric age-appropriate formulations10aNeglected tropical diseases (NTDs)10aOral Formulation10aPreventive chemotherapy (PC)1 aAl-Obaidi I1 aKrome AK1 aWagner KG1 aPfarr K1 aKuesel AC1 aBatchelor HK00aDrugs for neglected tropical diseases: availability of age-appropriate oral formulations for young children uhttps://parasitesandvectors.biomedcentral.com/counter/pdf/10.1186/s13071-022-05546-7.pdf a1-220 v153 a

It is recognised that paediatric indications and age-appropriate formulations are required to ensure that paediatric populations receive appropriate pharmacotherapeutic treatment. The lack of information on dosing, efficacy and safety data (labelling) is a well-recognised problem for all diseases affecting children. For neglected tropical diseases, the fact that they affect to a large extent poor and marginalised populations in low- and middle-income countries means that there is a low economic return on investment into paediatric development activities compared to other diseases [e.g. human immunodeficiency virus (HIV)]. This review provides an introduction to issues affecting the availability and development of paediatric population-relevant data and appropriate formulations of drugs for NTDs. We are summarising why age-appropriate formulations are important to ensure treatment efficacy, safety and effectiveness, outline initiatives to increase the number of paediatric indications/labelling and age-appropriate formulations, provide an overview of publicly available information on the formulations of oral drugs for NTDs relative to age appropriateness and give an introduction to options for age-appropriate formulations. The review completes with ‘case studies’ of recently developed paediatric formulations for NTDs, complemented by case studies for fixed-dose combinations for HIV infection in children since such formulations have not been developed for NTDs.

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