The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published its fifth new monograph, Chloral hydrate 100 mg/mL oral solution, in the European Paediatric Formulary. The monograph was published for public consultation in Issue 5 of Pharmeuropa PaedForm in January 2023, approved by the European Pharmacopoeia Commission at its 176th session in June 2023 and recently adopted by the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH).
The formulation described in the Chloral hydrate 100 mg/mL oral solution 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 experts in the working party chose the 100 mg/mL strength as this was the most commonly used, but were aware that other concentrations – ranging from 25 to 200 mg/mL – are prepared throughout Europe. The original qualitative and quantitative composition of the solution was provided by the German Neues Rezeptur-Formularium (NRF) and the formulation was tested using established pharmacopoeial test methods that were determined to be suitable following verification by the co-rapporteur of the monograph. The monograph also points out, in the Additional information section, that the use of chloral hydrate is restricted in some member states.
The European Paediatric Formulary gathers together, at 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 adopted, they are made available to pharmacists and clinicians to help them prepare paediatric medicines when no licensed product is available. The formulary will be expanded gradually over the following years to ensure that it fully serves its purpose. Monographs on Clonidine hydrochloride oral solution and Furosemide oral solution will be finalised in the coming months.
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