Abstract

FORMULATION DEVELOPMENT AND EVALUATION OF PULSATILE RELEASE TABLETS OF CELECOXIB CONTAINING HPMC, SODIUM ALGINATE AND ETHYL CELLULOSE

Dr. C. Sadak Vali*, Dr. S. Siva Prasad, N. M. Vageesh, Vadduri Swati, B. Nageswara Naik

ABSTRACT

Pulsatile drug delivery systems are time controlled release systems which releases the active pharmaceutical ingredient in preprogrammed time after a predetermined lag time. Chronotherapeutics is a discipline of science which deals with treatment of disease based on circadian rhythm and pathological state of disease. The aim of the present work was to develop and evaluate oral pulsatile delivery system of Anti-inflammatory drug, Celecoxib. Pulsatile drug delivery systems release the drug after fixed lag time in CVS disorders, diabetes mellitus, bronchial asthma, rheumatoid arthritis and ulcers. Celecoxib is a NSAID used in relieving of pain in rheumatoid arthritis. Pulsatile tablets consists of core and coat layers. Core tablets were prepared using super disintegrant and core tablets were then press coated with release rate retarding polymers. Drug and excipient compatibility was carried out by using FTIR studies. Press coated pulsatile release tablets of celecoxib were evaluated for hardness, thickness, friability, weight variation, disintegration time and dissolution. Dissolution tests of Press coated pulsatile release tablets of celecoxib were conducted in USP dissolution apparatus containing 0.1 N HCL acidic buffers for 2 hours and in phosphate buffer pH 6.8 for remaining 6 hours. Core tablets of formulation CC-19 released tablets released 99.89% drug after 8 hours. Accelerated stability studies were carried out for 90 days after preparation of tablets. Optimized formulation CC-19 had shown better micromeritic properties, less variation in weight, high drug content, less friability, fast disintegration and better hardness and dissolution profile.

Keywords: Pulsatile drug delivery system, Celecoxib, CDR, Chrono modulated, Circadian rhythm.