The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released issue 7 of Pharmeuropa PaedForm, in which the draft text for Furosemide 2 mg/mL Oral Solution is published for public consultation with a view to its later inclusion in the European Paediatric Formulary. The deadline for comments is 30 September 2023. This is the second round of public consultation for this text that was first published in issue 2 of Pharmeuropa PaedForm.
The formulation described in the Furosemide 2 mg/mL Oral Solution monograph was selected on the basis of the criteria for inclusion and evaluation of monographs established for the European Paediatric Formulary that were adopted at the end of 2015.
This ethanol-free formulation for paediatric use was selected to provide an age-appropriate alternative to currently authorised furosemide oral solutions that contain a significant amount of ethanol, an excipient considered to be of concern for certain patient populations, notably children. The original qualitative and quantitative composition of the solution and validated test methods were provided by Charles University, Prague, Czech Republic.
Furosemide 2 mg/mL Oral Solution is ethanol-free but contains other excipients and preservatives that ensure the stability of the active substance throughout its shelf life. However, during the first round of public consultation, concerns were raised about the efficacy of the antimicrobial preservation provided by the 0.10 per cent (m/m) methyl parahydroxybenzoate concentration included in the formulation.
These concerns were subsequently confirmed by an experimental verification which showed that a methyl parahydroxybenzoate concentration of not less than 0.15 per cent (m/m) was required for adequate antimicrobial preservation (testing according to European Pharmacopoeia general chapter 5.1.3. Efficacy of Antimicrobial preservation). In view of this finding, the Working Party experts revised the initial formulation, increasing the methyl parahydroxybenzoate content to 0.15 per cent (m/m).
The EDQM welcomes all comments on the revised monograph from users and interested parties.
The European Paediatric Formulary gathers together, at a European level, monographs on formulations for extemporaneous preparations that are either described in national formularies or well established in Europe. Once these monographs, which are not legally binding, have been 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 age-appropriate alternative is available.
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