Back European Paediatric Formulary: Flecainide acetate oral solution and Valaciclovir oral solution monographs in public consultation

EDQM Strasbourg, France 05/12/2023
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European Paediatric Formulary: Flecainide acetate oral solution and Valaciclovir oral solution monographs in public consultation

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 8 of Pharmeuropa PaedForm. The experts of the PaedF working party are glad to publish the ninth and tenth monographs for public consultation, Flecainide acetate 10 mg/mL oral solution and Valaciclovir 20 mg/mL oral solution, with a view to their subsequent inclusion in the European Paediatric Formulary. The deadline for comments is 31 March 2024.

The formulations described in the Flecainide acetate 10 mg/mL oral solution and Valaciclovir 20 mg/mL oral solution monographs were 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 need for age-appropriate formulations was highlighted by the European Medicines Agency (EMA) in 2013 and no authorised oral products are currently available.

For the Flecainide acetate oral solution monograph, experts in the Working Party chose the 10 mg/mL strength to support typical single doses of 2-8 mg/kg. The Working Party also intends to develop a monograph for a 2 mg/mL strength, which would be even more appropriate for neonates. The experts are aware that concentrations ranging from 2 to 20 mg/mL are prepared throughout Europe. The original qualitative and quantitative composition of the solution, preparation instructions and validated analytical procedures were provided by Dr Zanon from the Institute for Maternal and Child Health IRCCS Burlo Garofolo, Trieste, Italy.

For the Valaciclovir oral solution monograph, experts in the Working Party preferred a strength of 20 mg/mL as it was the only known formulation that did not contain a commercial vehicle. Concentrations ranging from 20 to 50 mg/mL are prepared throughout Europe. Valaciclovir is prescribed with reference to the anhydrous base, with the formulations prepared using a suitable mass of valaciclovir hydrochloride or valaciclovir hydrochloride hydrate. The formulation is based on valaciclovir hydrochloride hydrate because the hydrate is easier for pharmacies to source from suppliers. The original qualitative and quantitative composition of the solution, preparation instructions and validated analytical procedures were provided by the Dutch Pharmacist’s Formulary (FNA).

The protocols for preparation of the flecainide acetate and valaciclovir oral solutions and performance of the respective analytical procedures were found to be suitable following practical verification.

The PaedF Working Party and the EDQM welcome all comments on these new monographs from users and interested parties by 31 March 2024.

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 alternative is available.

Both the European Paediatric Formulary and Pharmeuropa PaedForm are available free of charge and can be accessed online after creating an account.