Tackling public health challenges
Paediatric Formulary – Improving access to child-appropriate formulations
The European Paediatric Formulary (PaedForm) provides free access to monographs on extemporaneous formulations for paediatric use, especially where no appropriately licensed medicines are available. By compiling best practices from national and regional formularies across Europe, it supports healthcare providers in delivering safe and effective treatments for children. The European Paediatric Formulary Working Party (PaedF WP) is composed of committed experts striving to provide age-appropriate formulations for preparation in pharmacies.
Amiodarone capsules monograph published in PaedForm
The new monograph strengthens standardisation and quality requirements for the preparation of paediatric amiodarone.
Amiodarone is used in children for serious arrhythmias, but licensed age-appropriate dosage forms are not always available in routine practice. In response, and following a successful public consultation, the PaedForm added Amiodarone hydrochloride, capsules (5-200 mg) as a new monograph developed by the PaedF Working Party. It was the 10th monograph published in the formulary and the first to cover a capsule formulation and different strengths (5 to 200 mg).
The original qualitative and quantitative composition of the formulation, preparation instructions and analytical procedures were provided by the French “Formulaire National” (ANSM) and adapted for the purposes of this monograph.
Isoniazid 50 mg/mL oral solution monograph in public consultation
A draft monograph for a paediatric oral solution entered consultation, supporting access to tuberculosis treatment suitable for children.
The EDQM published the 11th monograph of the PaedF WP, Isoniazid 50 mg/mL oral solution, for public consultation in Issue 10 of Pharmeuropa PaedForm. The need for age-appropriate formulations of this medicinal product was highlighted by the European Medicines Agency (EMA) in 2013, yet no licensed age-appropriate products are currently available.
This particular formulation – based on a formulation of the Spanish National Formulary – was selected because it was supported by a validated test method and stability data, both of which were provided by the University of Seville. The protocols for preparation of the isoniazid 50 mg/mL oral solution and performance of the respective analytical procedures were found to be suitable following experimental verification, during which the potential formation of hydrazine in the oral solution was highlighted.
Lorazepam 1 mg/mL oral solution monograph in public consultation
Issue 11 of Pharmeuropa PaedForm included a monograph aimed to address long‑standing gaps in paediatric formulations for anxiety management and premedication for anaesthesia.
The EDQM published the 12th monograph of the PaedF WP, Lorazepam 1 mg/mL oral solution, for public consultation in Issue 11 of Pharmeuropa PaedForm. Lorazepam, a benzodiazepine derivative, can be used in paediatric populations for the treatment of anxiety and as a premedication for anaesthesia. Although the need for age-appropriate formulations of this medicinal product was highlighted by the EMA in 2013, no licensed age-appropriate products are currently available.
The formulation described in the Lorazepam 1 mg/mL oral solution monograph is based on an existing unlicensed extemporaneous preparation developed in the Netherlands. It is supported by validated test methods and stability data provided by the Erasmus Medical Centre in Rotterdam and by the Laboratory of Dutch Pharmacists (LNA). Due to lorazepam’s low solubility in water, a glycerol-based vehicle was selected, with macrogol 400 and propylene glycol as co-solubilisers. As part of the routine experimental verification step, this formulation was tested and found to meet the requirements of Ph. Eur. general chapter 5.1.3. Efficacy of antimicrobial preservation.
European Paediatric Formulary: enhancing accessibility and functionality
An updated PaedForm platform improves online navigation and usability, making quality‑assured paediatric standards easier to access.
The PaedForm platform continued to evolve, boosting its usability and reach across Europe. In a significant step forward, all texts published in the formulary were made available in French. This not only broadened access for French-speaking healthcare professionals, it also brought the platform into conformity with the Council of Europe’s Language Policy and the principle of parity between the two official languages – English and French.
In addition, new filters for “active substance” and “pharmaceutical form” were added to enhance navigation and improve searchability, allowing users to locate relevant monographs more efficiently and supporting more targeted searches. The table of contents was also redesigned to include two new entries that clearly separate general texts from monographs, streamlining the user experience.