The European Directorate for the Quality of Medicines & HealthCare (EDQM) has added two new monographs Clonidine hydrochloride 10 µg/mL oral solution and Furosemide 2 mg/mL oral solution, to the European Paediatric Formulary after a successful public consultation phase. The Formulary now comprises seven monographs.
Both formulations described in the two monographs, which are not legally binding, were 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 published formulation of Clonidine hydrochloride 10 µg/mL oral solution was selected as it was supported by validated test methods and stability data kindly provided by Dr Büttner from the University Hospital Carl Gustav Carus of the Technical University of Dresden. The production steps and test methods were verified by the experts of the working party.
A first version of the formulation for the Furosemide 2 mg/mL oral solution draft monograph was selected to provide an ethanol-free alternative to licensed furosemide oral solutions and published in Issue 2 of Pharmeuropa PaedForm (2020). However, during the public enquiry, concerns were raised that the content of methyl parahydroxybenzoate was too low to provide adequate antimicrobial preservation of the product. To address these concerns, the PaedForm Working Party proceeded to perform a microbial challenge test (as per European Pharmacopoeia general chapter 5.1.3) on samples of the preparation to identify the lowest methyl parahydroxybenzoate concentration that would adequately preserve the product. The study revealed that a concentration of 0.15 per cent (m/m) was necessary to comply with the requirements for efficacy of antimicrobial preservation laid out in general chapter 5.1.3. Considering those results, the initial formulation was modified and then published a second time for public consultation. This monograph, which was the third monograph added to the PaedForm work programme by the expert working party, showed that the practical verification – including microbiological testing – of chosen formulations and analytical methods are key to ensuring that the monographs in the formulary are of the most appropriate quality.
Both the European Paediatric Formulary and Pharmeuropa PaedForm are available free of charge and can be accessed online after creating an account.
See also:
- Access the European Paediatric Formulary and the public consultation platform
- More about the European Paediatric Formulary