Research in the field of paediatric drug formulation

F. Marçon1,2 1. Pharmacie à Usage Intérieur, département conception, fabrication et contrôle du médicament, CHU Amiens- Picardie, Amiens, France.
2. Laboratoire AGIR EA 4294, Université de Picardie Jules Verne, Amiens, France

During the last twenty years, health authorities (EMA and FDA) have noted a lack of development of the paediatric drug. Despite the introduction of incentive policies, many medicines, including medicines that have lost their patent, still suffer from a lack of formulation adapted to paediatric use, or a lack of efficacy or safety data that can be reviewed by a health authority.

This lack of development is the result of several constraints and difficulties making the industrial development of the paediatric drug difficult: a galenic development of a suitable and stable form, most often liquid, sometimes complex; clinical trials on a physiologically and pharmacokinetically heterogeneous population that may be more complex than in adults.

Research in the field of paediatric formulation is a broad area ranging from basic research in the development of technical solutions (e.g., drug printing) to translational research on formulation development (e.g., development of an oral solution of midazolam using cyclodextrins), as well as clinical research on the use of these formulations (e.g., pharmacokinetics, efficacy, safety studies) necessary to assess the benefit/risk balance and support use of therapeutics.

When developing a paediatric formulation, the pharmacist must select all the raw materials without losing sight of the fact that their qualities or quantities may have an impact on the physicochemical stability of the drug, biopharmaceutical aspects, the pharmacokinetics, the acceptability, the efficacy and the safety of the drug. The principle of parsimony should guide the formulation.

Finally, in this field of research, non-profit organizations, and in particular university hospitals, have a major role to play in the development of solutions for the management of paediatric populations. In this context, learning how to value research work can help facilitate the development of paediatric medicines.

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