Development and Evaluation of A Pulsatile Drug Delivery System For Chronotherapeutic Drug Delivery

Abstract

Pulsatile drug delivery systems (PDDS) are advanced drug delivery approaches designed to release a therapeutic agent after a predetermined lag time, followed by a rapid or controlled release phase. Such systems are particularly useful for chronotherapy, where drug release needs to be synchronized with the temporal pattern of disease symptoms. The present study focuses on the design, formulation, and optimization of a polymer-based pulsatile drug delivery system intended to achieve time-controlled drug release. The formulation was developed using suitable hydrophilic and/or hydrophobic polymers to provide an effective barrier around the drug-containing core and to regulate the lag time. Different formulation variables, including polymer type, polymer concentration, coating thickness, and drug-to-polymer ratio, were investigated to optimize the desired release characteristics. The prepared formulations were evaluated for physical characteristics, drug content, lag time, and in-vitro drug release behavior. Optimization was performed by assessing the influence of formulation variables on the lag time and subsequent drug-release profile. The optimized formulation was expected to exhibit a predetermined lag period followed by rapid and reproducible drug release, demonstrating the potential of polymer-based systems for chronomodulated drug delivery. The developed approach may provide a promising platform for improving therapeutic outcomes in diseases exhibiting time-dependent or circadian patterns of symptoms.