Pediatric Drug Product Development through to Commercialization

In recent years, there has been a notable shift away from the traditional route of administration for pediatric medicines, namely oral liquid formulations, to solid oral dose formulations such as granules and minitablets.

Meeting the requirements of the EU Pediatric Regulation (EC1901/2006 and EC1902/2006) and the US requirement for inclusion of Pediatric Investigation Plans (PIP) in all new Marketing Authorisations, Almac’s US headquartered client sought to develop a pediatric dosage form of their existing commercialized 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 pediatric formulation for a first in class product with a robust manufacturing process suitable for routine commercial manufacture.