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Title Paediatric Dosage Forms: A Review of Age Development and Dosage Forms of Choice
Authors Hamad Alyami
Description Paediatric medication development has advanced extensively worldwide due to legislative encouragements and requirements directed towards the development of studies of drugs for use in the paediatric population (FDA, 1994). European Medicines Agency (EMA) has reviewed its legislative requirements to drive innovations in paediatric formulations (European Commission, 2013). An approved paediatric investigation plan is required for all new drugs and all line extensions that are submitted for EMA approval after January 2009. Such plans should cover all paediatric age groups. Furthermore, the EMA has issued guidelines on pharmaceutical development of medicines for paediatric use including route of administration, dosing frequency, excipients, patient acceptability, container closure systems and devices and user information (CHMP, 2006, Gauthier and Cardot, 2011). The FDA has issued in 2012, a law requiring the implementation of the Paediatric Research Equity Act and Best Pharmaceuticals for Children Act (Christensen, 2012). Similar to the EMA requirements, a paediatric study plan (PSP) is required for submission and approval by the FDA (FDA, 2013). Oral route of administration is inevitably the most popular route of delivery due to ease of ingestion, availability of a wide variety of dosage forms and most significantly enhanced compliance and adherence. Different drug formulations can be administered orally, including solid and liquid dosage forms (Fasano, 1998, Sastry et al.,).