Formulation and Evaluation of a Press-Coated Pulsatile Drug Delivery System of Telmisartan for Chronotherapeutic Management of Hypertension

Abstract

Hypertension exhibits a circadian rhythm, with blood pressure rising sharply during the early morning hours, thereby increasing the risk of cardiovascular events. Chronotherapeutic drug delivery systems are designed to release drugs in alignment with biological rhythms to improve therapeutic outcomes. The present study aimed to formulate and evaluate a press-coated pulsatile drug delivery system of Telmisartan using hydrophilic polymer HPMC K4M and hydrophobic polymer Ethyl Cellulose. Core tablets of Telmisartan were prepared by direct compression and optimized based on pre-compression and post-compression parameters. The optimized core tablet (C2) was further press-coated with varying concentrations of HPMC K4M and Ethyl Cellulose to achieve desired lag time. The prepared pulsatile tablets were evaluated for weight variation, hardness, thickness, friability, drug content, in-vitro dissolution, and stability studies. Among all formulations, batch F2 exhibited optimum lag time with 96.3% cumulative drug release at the end of 8 hours and satisfactory mechanical properties within pharmacopoeial limits. Accelerated stability studies conducted as per ICH guidelines revealed no significant changes in physical characteristics or drug release profile. The results indicate that the developed press-coated pulsatile drug delivery system of Telmisartan can effectively provide chronotherapeutic drug release and may improve therapeutic efficacy and patient compliance in hypertension management.