Europe – European Paediatric Formulary: two draft texts released for public consultation

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 4 of Pharmeuropa PaedForm, which contains two texts for public consultation, Simple syrup (preservative-free) and Phosphate 60 mg/mL Oral solution, prior to their inclusion in the European Paediatric Formulary.

The Simple syrup (preservative-free) monograph was selected to provide users with a standardised vehicle for oral liquids that could be cross-referenced in other European Paediatric Formulary monographs. This simple syrup can also be used as a standardised vehicle in which to suspend or dissolve solid dosage forms immediately before administration. A review of simple syrups used in Europe revealed that concentrations varied between 63% and 66%; 64% was selected for the monograph because this was the most commonly used concentration. The consolidated monograph was drafted taking into account existing test methods and limits present in monographs in Europe. The production steps and test methods were verified experimentally…