Back European Paediatric Formulary: Amiodarone hydrochloride capsules (5 mg-200 mg) monograph in public consultation

EDQM Strasbourg, France 11/06/2024
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European Paediatric Formulary: Amiodarone hydrochloride capsules (5 mg-200 mg) monograph in public consultation

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 9 of Pharmeuropa PaedForm, containing the 11th monograph of the PaedF Working Party, Amiodarone hydrochloride capsules (5 mg-200 mg) for public consultation. The deadline for comments is 30 September 2024

The formulation described in the Amiodarone hydrochloride capsules (5 mg-200 mg) 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 need for age-appropriate formulations of this medicinal product was highlighted by the European Medicines Agency (EMA) in 2013 and no licensed age-appropriate products are currently available.

Given that numerous dosing regimens are possible for amiodarone, the Working Party experts chose to describe a formulation that covers a broad range of strengths (from 5 mg to 200 mg). The capsules described in the monographs can be opened and their contents mixed with food or drink, just before administration. The original qualitative and quantitative composition of the capsules, instructions for preparation and analytical procedures were provided by the French “Formulaire national” (ANSM) and adapted for the purposes of this monograph.

The protocols for preparation of the amiodarone hydrochloride capsules and performance of the respective analytical procedures were found to be suitable following practical verification.

An alternative formulation (with lactose as a filler) was also evaluated but was rejected because, while it complied with the requirements for uniformity of dosage units for the strengths tested (5 mg to 50 mg), the stability test results obtained after 6 months indicated a potential lactose-amiodarone hydrochloride interaction.

The PaedF Working Party and the EDQM welcome all comments on the new monograph from users and interested parties by 30 September 2024.

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