The European Directorate for the Quality of Medicines & HealthCare (EDQM) has added a new monograph, Phosphate 60 mg/mL Oral Solution, to the European Paediatric Formulary. Elaborated by a dedicated European Pharmacopoeia (Ph. Eur.) working party, the monograph was initially published in Issue 3 of Pharmeuropa PaedForm, then approved by the Ph. Eur. Commission and adopted by the European Committee on Pharmaceuticals and Pharmaceutical Care.
The formulation described in the Phosphate 60 mg/mL Oral Solution monograph was selected on the basis of the European Paediatric Formulary’s inclusion and evaluation criteria that were adopted in 2015. The original qualitative and quantitative composition of the solution, method of preparation and validated test methods were provided by AIDA APL (Sweden) and were then slightly modified for the benefit of users following verification by the co-rapporteur of the monograph. Several similar formulations prepared in Europe were examined by the experts in the working party, but the formulation provided by APL was considered most appropriate by the group and met the aforementioned criteria.
The European Paediatric Formulary gathers together, on a European level, monographs on formulations for extemporaneous preparations that are either described in national formularies or are well-established in Europe. These monographs are not legally binding. Once approved by the Ph. Eur. Commission and adopted by the European Committee on Pharmaceuticals and Pharmaceutical Care, they are made available to pharmacists and clinicians to help them prepare paediatric medicines when no authorised alternative is available.
The European Paediatric Formulary is free of charge and can be accessed online after creating an account.