Formulation and characterization of in-situ injectable implant of lornoxicam
Formulation and characterization of in-situ injectable implant of lornoxicam
Soni Ankitkumar Kiritkumar
: J Pharm Drug Deliv Res
Abstract
The focus of this study was to develop and optimize in-situ injectable implant of lornoxicam for long term treatment of arthritis and musculoskeletal inflammatory disorders, prepared with using different concentrations and ratios of PLGA. Drug-excipients interaction was characterized by DSC and FTIR. The different biocompatible solvents benzyl alcohol, poly ethylene glycol 400 and dimethyl sulfoxide were used in the formulation which were easily miscible in water and formed implant rapidly. The formulation was prepared by polymer precipitation method. The formulations were evaluated for drug entrapment efficiency, cumulative percentage drug release, surface morphology, rheological behaviour. The formulation was characterized by Scanning Electron Microscopy (SEM) showed crosslinking of polymer with uniform implant formation and porous surface by their degradation at different time intervals. The formulation with 35% PLGA 50:50 concentrations exhibited minimum burst release of drug and sustained the release of drug till 5 days by increase in the polymer concentration. Clarity and pH were found in acceptable range. Release kinetics revealed that all formulations followed zero order kinetic. The optimized formulation was subjected to in-vivo gelling study and pharmacokinetic study using Sprague-Dawley rats, and it persisted till 7 days without any tissue damage also Cmax, Tmax, AUC and t1/2 were significantly higher than marketed I.M injection. Clinical efficacy of prepared formulation was assessed by determining statistical analysis. Stability study of optimized formulation was performed at 25±2°C/60±5% RH and40±1°C and 75%RH showed no change in physical and chemical characteristics.
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