Formulation optimization and characterization of venlafaxine HCL sustained release pellets

Abstract

Venlafaxine HCl, a serotonin-norepinephrine reuptake inhibitor (SNRI), requires frequent dosing due to its short half-life, which can lead to poor patient compliance and fluctuating plasma levels. This study focuses on the formulation and optimization of sustained release (SR) pellets of Venlafaxine HCl using extrusion-spherization and coating techniques to achieve prolonged drug release. A design of experiments (DoE) approach was employed to optimize critical formulation variables such as polymer concentration, spherization speed, and coating thickness. The optimized formulation showed excellent pellet morphology, desirable drug content, and sustained in vitro drug release over a 12–24-hour period. Characterization was carried out using Fourier Transform Infrared Spectroscopy (FTIR), Differential Scanning Calorimetry (DSC), Scanning Electron Microscopy (SEM), and in vitro dissolution studies to ensure stability, compatibility, and performance. The developed SR pellets of Venlafaxine HCl can potentially enhance patient adherence and provide more consistent therapeutic outcomes in the management of depression.