Dr. Oliver Schinzinger, Dr. Eva Fahrländer, and Dr. Christoph Rott, CordenPharma Plankstadt
The development of pediatric medicine poses numerous challenges to pharmaceutical formulators, particularly products intended for infants and very young children. The EU Regulation 1901/2006 on medicinal products for pediatric use rightly states that children are not simply small adults and that pediatric treatments must thus be tailored to the specific needs of children of various age groups. This means that developers must carefully select a dosage form that is appropriate for young patients in terms of administration and palatability, especially in the case of highly potent medicines used for various indications such as oncology.
CordenPharma Plankstadt, near Frankfurt, Germany, specializes in the development and manufacturing of oral solid dosage forms for highly potent compounds, with extensive experience in pediatric formulations. This white paper describes special considerations for selecting appropriate pediatric dosage forms and the benefits of choosing mini-tablets (e.g., orodispensible) for pediatric formulation, particularly for highly potent compounds.