Isoniazid 50 mg/mL oral solution, the 11th PaedForm monograph developed by the European Paediatric Formulary (PaedF) Working Party, has been published in the European Paediatric Formulary following public consultation on the draft. The monograph describes an age-appropriate oral formulation used in the treatment or prevention of tuberculosis. The need for paediatric formulations of this medicinal product was highlighted by the European Medicines Agency (EMA) in 2013, and no licensed age-appropriate products are currently available in most member states.
The formulation of the isoniazid 50 mg/mL oral solution covered by the monograph was selected on the basis of the inclusion and evaluation criteria. It is based on a formulation published in the Spanish National Formulary and was selected because it was supported by a validated test method and stability data, both of which were provided by the University of Seville.
Experimental verification during development showed that the protocols for preparation of the oral solution and performance of the corresponding analytical procedures were suitable, although a potential for hydrazine formation in the oral solution was observed. To ensure that hydrazine levels remain acceptable, it is important to store the formulation at 2‑8°C and to keep the shelf life after opening to a strict minimum.
The complete work programme of the PaedF Working Party is available online. Stakeholders are invited to get in touch and to share proposals for any additional items to be covered in the Formulary via the EDQM HelpDesk.
To access the monograph on Isoniazid 50 mg/mL oral solution on the PaedForm website, users must first create an account with a valid e-mail address. Please register using the link at the top of the page. Further details on how to create your account and use the European Paediatric Formulary can be found in PaedForm website user manual.
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