Development and Evaluation of bi-layer Tablet Containing Sustained-Release and Immediate Release Celecoxib

The purpose of this study is to prepare a bilayer tablet of Celecoxib using wet granulation technology and to formulate an optimized formulation. Celecoxib is a non-steroidal anti-inflammatory drug that inhibits the prostaglandin-generating enzyme cyclo-oxygenase 2 and reduces the pain and inflammation of Osteoarthritis. Fast release of the drug from the immediate-release layer can give a rapid onset of action which will help to reduce pain and inflammation within a short period while the maintenance dose of Celecoxib will maintain plasma concentration within the therapeutic range for 24 hours. Permeability enhancers such as Chitosan were used, which can increase the permeability as well as bioavailability of the drug. In this study, a bilayer tablet was prepared which contains an immediate release layer and a sustained release layer. HPMC K100 was used to maintain sustained release and Croscarmellose Sodium for immediate release. Sodium Starch Glycolate and Cross Povidone were used as super disintegrants. The bilayer tablets were tested for weight variation, hardness, friability, thickness, drug content, in-vitro dissolution profile, bulk density, tapped density, angle of repose, carr’s index, Hausner's ratio, and calibration curve. The granules showed satisfactory flow properties and compressibility. The best formulation L5 showed a High % drug release 96.04% release, high drug content, high hardness, and friability. Bilayer tablet is enhancing beneficial technology to control the shortcomings of the single-layered tablet. The aim of designing sustained or controlled delivery systems is to decrease the repetition of the dosing or to increase the effectiveness of the drug by localization at the site of action, lowering the dose required, or providing uniform drug delivery. The main objective of sustained release drug delivery is to make sure safety and to improve patient compliance.