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Paediatric Drug Product Development through to Commercialisation
In recent years, there has been a notable shift away from the traditional route of administration for paediatric medicines, namely oral liquid formulations, to solid oral dose formulations such as granules and minitablets.
Meeting the requirements of the EU Paediatric Regulation (EC1901/2006 and EC1902/2006) and the US requirement for inclusion of Paediatric Investigation Plans (PIP) in all new Marketing Authorisations, Almac’s US headquartered client sought to develop a paediatric dosage form of their existing commercialised adult drug product.
This case study explores the successful partnership of Almac, our US client partner and third party vendor Merz in delivering a minitablet in stickpack sachet paediatric formulation for a first in class product with a robust manufacturing process suitable for routine commercial manufacture.
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