The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 3 of Pharmeuropa PaedForm, in which the draft text for Phosphate 60 mg/mL Oral Solution is published for public consultation prior to its inclusion in the European Paediatric Formulary. This is the fourth monograph elaborated by the PaedForm Working Party.
The formulation included in the Phosphate 60 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 original qualitative and quantitative composition of the solution and validated test methods were provided by AIDA APL (Kungens Kurva, Sweden) and were slightly modified for the benefit of users following verification by the co-rapporteur of the monograph. The experts in the working party also considered several similar formulations prepared in Europe. However, the formulation provided by APL was the most appropriate formulation known to the group that met the criteria.
The EDQM welcomes all comments on this new monograph from users and interested parties.
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 and once approved by the European Pharmacopoeia 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.
Both the European Paediatric Formulary and Pharmeuropa PaedForm are free of charge and can be accessed online after creating an account.
The deadline for comments on Phosphate 60 mg/mL Oral Solution is 31 March 2021.