Background: Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disorder exhibiting pronounced circadian rhythm, with peak joint stiffness and pain occurring in early morning hours. Conventional immediate-release formulations fail to synchronize drug delivery with this biological rhythm. Chronotherapeutic drug delivery systems, particularly pulsatile systems, offer a promising strategy to deliver medication following a programmed lag time. Objective: The present study aimed to formulate and evaluate press-coated pulsatile release tablets of lornoxicam capable of providing a predetermined lag time followed by rapid drug release suitable for early morning management of RA symptoms. Methods: Immediate-release core tablets were prepared by wet granulation using microcrystalline cellulose, crospovidone, PVP K-30, and β-cyclodextrin. Optimized cores were press-coated with suitable enteric polymers to achieve approximately 5-hour lag time. Preformulation studies included organoleptic evaluation, melting point determination, UV spectrophotometric analysis (λmax 261 nm), calibration curve construction, solubility studies, and drug–excipient compatibility assessment. Powder blends were evaluated for flow properties. Compressed tablets were assessed for hardness, friability, weight variation, thickness, drug content uniformity, and in vitro dissolution studies. Results: Calibration curve showed excellent linearity (R² ≈ 0.999). Pre-compression parameters indicated good flowability. Post-compression parameters complied with pharmacopeial standards. Dissolution studies demonstrated negligible drug release during lag phase followed by rapid release after 5 hours, confirming pulsatile behavior. Conclusion: The developed press-coated pulsatile tablet of lornoxicam successfully synchronized drug release with circadian rhythm of RA, indicating its potential as an effective chronotherapeutic system.
Mayur Rajput*, Dr. Aman Kansare, Dr. Sachin Jain (Wed,) studied this question.