Formulation Development and Pharmacokinetic Evaluation of Sustained-Release Lornoxicam Matrix Tablets Using Hydrophilic Polymers

Abstract

Background: Lornoxicam is a potent non-steroidal anti-inflammatory drug (NSAID) widely prescribed for the treatment of pain and inflammatory disorders. Owing to its short elimination half-life (approximately 3–5 hours), conventional dosage forms require frequent administration, resulting in fluctuating plasma drug concentrations and reduced patient compliance. Sustained-release (SR) formulations offer an effective strategy to maintain therapeutic drug levels for prolonged periods while minimizing dosing frequency and adverse effects. Objective: The present study aimed to formulate and evaluate sustained-release matrix tablets of Lornoxicam using different grades of Hydroxypropyl Methylcellulose (HPMC K4M, HPMC K15M, and HPMC K100M) and to investigate their in vitro release characteristics and pharmacokinetic performance. Materials and Methods: Sustained-release matrix tablets containing Lornoxicam were prepared by the direct compression method using different concentrations of HPMC polymers. Pre-compression parameters including angle of repose, bulk density, tapped density, Carr's index, and Hausner's ratio were evaluated to determine flow characteristics. The compressed tablets were assessed for weight variation, hardness, friability, thickness, drugcontent, and in vitro dissolution. Drug–polymer compatibility was investigated using Fourier Transform Infrared Spectroscopy (FTIR). Drug release kinetics were analyzed using Zero-order, First-order, Higuchi, and Korsmeyer–Peppas models. Pharmacokinetic evaluation was performed by comparing the optimized sustained-release formulation with a conventional immediate-release formulation. Results: All formulations exhibited acceptable pre-compression and post-compression characteristics in accordance with pharmacopeial limits. FTIR analysis confirmed the absence of significant drug–excipient interactions. The optimized formulation demonstrated sustained drug release over 12 hours with satisfactory physicochemical properties. Drug release predominantly followed Higuchi diffusion kinetics with anomalous (non-Fickian) transport. Pharmacokinetic evaluation indicated prolonged drug release, increased mean residence time, and improved maintenance of therapeutic plasma concentrations compared with the conventional formulation. Conclusion: The developed sustained-release Lornoxicam matrix tablets successfully provided prolonged drug release and demonstrated satisfactory pharmaceutical quality. The optimized formulation has the potential to improve patient compliance, reduce dosing frequency, and enhance therapeutic efficacy in the management of chronic inflammatory disorders.