Pharmacokinetic Evaluation Of Chronomodulated Esomeprazole Delivery For Improved Night-Time Gerd Managements

Abstract

Gastroesophageal reflux disease (GERD) exhibits a circadian pattern, with symptoms often intensifying during the night due to increased acid secretion and supine posture. Esomeprazole, a proton pump inhibitor (PPI), is widely used for GERD management but shows reduced efficacy when administered conventionally due to its pharmacokinetic limitations and mismatch with nocturnal acid secretion. This study focuses on the pharmacokinetic evaluation of a chronomodulated delivery system for esomeprazole, designed to align drug release with peak night-time acid production for enhanced therapeutic outcomes. The formulation was developed using time-dependent polymeric coatings to achieve delayed and sustained release, initiating drug release approximately 4–6 hours post-administration. In vivo pharmacokinetic studies in animal models revealed significant improvements in key parameters including C_max, T_max, and AUC, with enhanced bioavailability and extended plasma retention time. The chronomodulated system demonstrated superior acid suppression during the critical nocturnal window compared to conventional formulations. These findings suggest that chronotherapeutic delivery of esomeprazole may offer a promising approach to improving night-time GERD management, enhancing patient compliance, and minimizing sleep disturbances caused by reflux episodes. Further clinical validation is recommended to confirm its efficacy in human subjects.