The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 10 of Pharmeuropa PaedForm, containing the 11th monograph of the PaedF Working Party, Isoniazid 50 mg/mL oral solution, for public consultation. The deadline for comments is 30 June 2025.
The formulation described in the Isoniazid 50 mg/mL oral solution monograph was selected on the basis of the inclusion and evaluation criteria established for the European Paediatric Formulary that were adopted at the end of 2015. The need for age-appropriate formulations of this medicinal product was highlighted by the European Medicines Agency (EMA) in 2013 and no licensed age-appropriate products are currently available.
This particular formulation, which is based on a formulation of the Spanish National Formulary, was selected because it was supported by a validated test method and stability data, both of which were provided by the University of Seville.
The protocols for preparation of the isoniazid 50 mg/mL oral solution and performance of the respective analytical procedures were found to be suitable following experimental verification, during which the potential formation of hydrazine in the oral solution was highlighted. To ensure that hydrazine content remains below acceptable levels, it is important to store the formulation at 2‑8°C and to keep the shelf life after opening to a strict minimum.
The PaedF Working Party and the EDQM welcome all comments on the new monograph from users and interested parties by 30 June 2025.
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