Comparison of Standard and Biorelevant Media for the Evaluation of Enteric Capsule Performance

Vincent Jannin – Director, R&D, Capsugel France SAS; Brendan Griffin – Professor of Pharmaceutics & Head of School, School of Pharmacy/University College Cork; Joseph O'Shea – Senior Lecturer in Pharmaceutics, School of Pharmacy/University College Cork

Introduction: Capsule-based drug delivery systems have advanced considerably, enabling improved protection of active pharmaceutical ingredients (APIs) and controlled release along the gastrointestinal (GI) tract. Progress in polymer design has been especially important for the oral administration of labile molecules such as peptides, proteins, and RNA-based therapeutics [1]. For RNA-based drugs in particular, enteric protection is essential to withstand gastric conditions and ensure targeted release in specific intestinal regions [2,3]. In this context, dissolution and disintegration behavior are critical parameters for predicting capsule performance and site-specific delivery.