FABRICATION, OPTIMIZATION AND CHARACTERIZATION OF LORNOXICAM BILAYER TABLETS FOR BIPHASIC RELEASE
Main Article Content
Keywords
Lornoxicam, direct compression, FTIR analysis, guar gum, biphasic release.
Abstract
Lornoxicam is a member of oxicam family and nonsteroidal anti-inflammatory drug (NSAID), possessing short half-life. This study was opted to fabricate, optimize and evaluate lornoxicam bilayer tablets, which exhibit initial burst release of the drug inside the stomach and adhere to the release specifications of sustained release pharmaceuticals. The suggested bilayer tablets consist of two layers i.e. immediate release (IR) and sustained release (SR), in anticipation of initial drug release that begins inside the stomach to quickly relieve the symptoms with persistent action in the intestine to continue extended analgesic efficacy. Various formulations of bilayer tablets were produced using direct compression technique by altering the concentration of polymers, like guar gum, Carbopol 940P and HPMC K4M. The drug excipients compatibility was confirmed by FTIR scans. The formulations displaying the necessary flow characters were subjected to compression after the micromeritic characteristics of powder mixes were assessed. Various physico-chemical characterization tests were evaluated, and the multiple point in-vitro drug dissolution was achieved at pH 7.4. In-vitro drug release behavior demonstrated a profile of biphasic release, suggesting lornoxicam release from IR layer within 15 min while SR layer maintained drug release control for up to 24 hours. Model dependent as well as independent approaches were put in place to compare dissolution profiles of formulations. F9 was chosen as the best trial formulation based on controlled release pattern and physico-chemical characterization, including stability determination. The trial lornoxicam bilayer tablet formulations (F1-F9) complied with Fickian diffusion mechanism and zero-order release kinetics (n = 0.364–0.445). ANOVA statistical analysis revealed that the cumulative quantity of drug released after 15 min did not change significantly from optimized formulation, however the amount released after 24 h did differ significantly (p<0.05). Thus, the outcomes clearly indicated that the natural polymer guar gum was preferred for ensuring a biphasic release profile of lornoxicam.
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