Release testing strategies for oral granules (mini-tablets) enabling safe and efficient supply of pediatric drugs

The enactment of Regulation No 1901/2006 on medicinal products for pediatric patients, Pediatric Research Equity and Best Pharmaceuticals for Children Acts (PREA and BPCA), encouraged many pharmaceutical companies to consider development of pediatric formulation platforms for solid oral dosage forms. Mini-tablets have gained considerable interest for proven acceptability among children of almost all age groups, dose flexibility and superior stability compared to liquids. The demand for most pediatric drugs is generally low compared to adult products, resulting in a significantly higher proportion of the produced batch being allocated for release testing relative to the total available quantity. Given 1) the generally unfavorable economics of pediatric drug development, and 2) the need to ensure access to high quality medicines to all patients, including children, members of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ consortium) were motivated to develop flexible and efficient release testing strategies spanning dose strengths. Critical quality attributes and data to justify rational release strategies for mini-tablet dosage form are discussed.