(471-B) Formulation and Process Parameters Optimization in Chewable Tablet.

Co-Authors : Rajanikant Patel, Senior Scientist, R & D Product development, Granules Pharmaceuticals Inc., USA.
Introduction 
A Quality by Design (QbD) framework was employed for the development of a generic chewable tablet intended for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). The Quality Target Product Profile (QTPP) was established in alignment with the attributes of the Reference Listed Drug (RLD), and Critical Quality Attributes (CQAs) were identified based on the safety and therapeutic efficacy requirements of the proposed generic product. Formulation and process development were guided by an initial risk assessment, focusing on Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs). The finalized formulation demonstrated 24-month stability under ICH-recommended conditions and achieved in-vitro dissolution and in-vivo bioequivalence profiles comparable to the RLD.