The EDQM has just released issue 2 of Pharmeuropa PaedForm, in which the third monograph elaborated by the PaedForm Working Party, the draft text for an ethanol-free formulation for Furosemide 2 mg/mL Oral Solution, is published for public consultation prior to its inclusion in the European Paediatric Formulary.
The active substance, furosemide, and the formulation included in the Furosemide 2 mg/mL Oral Solution monograph were selected on the basis of the inclusion and evaluation criteria established for the Formulary that were adopted at the end of 2015. In this instance, an ethanol-free formulation for paediatric use was chosen because currently authorised furosemide oral solutions contain a significant amount of ethanol, which is of concern for specific age groups. Furosemide 2 mg/mL Oral Solution is therefore ethanol-free but contains other excipients and preservatives to ensure that the solution remains stable throughout its shelf-life. The original qualitative and quantitative composition of the solution and validated test methods were provided by Charles University, Prague, Czech Republic, and were modified slightly for the benefit of users following practical evaluation of the monograph.
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 Pharmeuropa PaedForm and the European Paediatric Formulary are free of charge and can be accessed after creating an account.
The deadline for comments on Pharmeuropa PaedForm, Issue 2, is 31 December 2020.