Formulation And Evaluation of Pulsatile Drug Delivery System

Pulsatile drug delivery systems (PDDS) are designed to release drugs in a transient manner, following a predetermined lag time, to synchronize with the body's circadian rhythms or specific biological events. This study aimed to develop and evaluate a press-coated pulsatile tablet of Telmisartan, a drug commonly used to treat hypertension, where blood pressure typically peaks in the morning. Preformulation studies confirmed the drug's purity and solubility profile, with UV spectroscopy determining the maximum wavelength at 295 nm. Standard calibration curves were linear (2-18 µg/ml) in a phosphate buffer (pH 6.8) at 295 nm. FT-IR spectroscopy showed no interaction between Telmisartan and the polymers used. Core tablets were evaluated for micromeritic properties, with bulk density ranging from 0.50 to 0.52 g/cc, tapped density from 0.57 to 0.59 g/cc, compressibility index from 10.34% to 13.79%, and a Hausner’s ratio between 1.11 and 1.16, indicating good flowability. Post-compression parameters for core tablets were within acceptable limits: weight variation (100-101 mg), hardness (3.4-3.6 Kg/cm²), friability (0.86-0.90%), thickness (3.0-3.2 mm), drug content (96.72-99.16%), and disintegration time (28-38 sec). In vitro dissolution studies showed that formulations with 4% Croscarmellose Sodium exhibited the fastest drug release. Pulsatile tablets were successfully developed and evaluated, demonstrating the potential for chronotherapeutic drug delivery, aligning drug release with circadian rhythms.