A large, multinational pharmaceutical company was seeking a CDMO partner with the expertise and technological capabilities to combine three drug substances into a fixed dose combination (FDC) product suitable for adult and pediatric dosing.
The incompatibility of one of the APIs with the other two and the need for flexible dosing for a diverse patient population were key challenges. These were overcome using a combination of multi-layer tablets for adults, mini-tablets for pediatric patients, and polymer coating technologies. In a second case, microparticulate technology was used to meet a customer’s needs for combining two APIs with different release profiles.
Read more about meeting the challenges for FDCs.