US Regulatory Considerations for Modified Release Products

Modified release (MR) products are engineered to release drugs in a controlled manner so that certain drug release pattern or pharmacokinetic profile can be generated to meet specific clinical needs. The US Food and Drug Administration is the federal agency responsible for new drug approval. This chapter provides readers with an overview of a development program for an MR dosage form on the basis of reference listed drug (RLD). MR dosage forms, with improved features or expanded clinical usage from RLDs, are generally developed after approvals of their RLDs. A clinical development program can be largely reduced if a new MR product is developed based on the agency's findings of efficacy and safety of the RLD. Postapproval changes, which include composition changes, scale up/scale down, manufacture site changes, manufacturing process, or equipment changes, may occur for either a generic MR product or a pharmaceutical alternative product.