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DEVELOPMENT OF A NOVEL ENTERIC COATED EXTENDED RELEASE PELLETS USING MODEL NSAID FLURBIPROFEN

The aim of this study was to develop a pH responsive enteric coated extended release pellets containing a model drug flurbiprofen, a nonsteroidal anti-inflammatory drug used for rheumatoid arthritis. The drug loaded pellets were prepared by using extrusion/ spheronization method. Core pellets were coated with polymer Eudragit RS30D in a coating pan to achieve a sustainable release for 12 hours. A ph responsive barrier coat of Eudragit L 100-55 was employed in a coating pan for abstaining release in acidic media. The drug excipient mixtures were subjected to pre-formulation studies. The pellets were subjected to physicochemical studies, in-vitro drug release, Kinetic studies and stability studies. FTIR studies shown there was no interaction between drug and polymers. The physicochemical properties of pellets were found within the limits. The drug release from the optimized formulations was extended for a period of 12 hrs i.e. first 2 hrs no drug release was observed and gradually drug release was increased up to 12 hrs. From the above results, achievement of site specific release to lower part of gastrointestinal tract might be due to Eudragit L 100-55 stability in acidic pH. The prepared pellets apart from fulfilling all official and other specifications, exhibited good extended release of Flurbiprofen. The optimized formulations were subjected to stability studies and shown there were no significant changes in drug content, physicochemical parameters and release pattern. In conclusion, development of Eudragit RS30D-Eudragit L 100-55 was novel and good approach to achieve the site specific release of drug to colon. INTRODUCTION: The term arthrities is used to describe changes in the joints which may be either inflammatory or degenerative in character 1, . Circadian variation in pain, stiffenss and manual dexterity in patients with osteo and rheumatoid arthritis have been studied and has implication for timing anti-rheumatoid drug treatment . Morning stiffness associated with pain at the time of awakening is a diagnostic criterion of the rheumatoid arthritis and these clinical circadian symptoms are supposed to be outcome of altered functioning of hypothalamic– pituitary adrenocortical axis. Chronopharmacotherapy for rheumatoid arthritis has been recommended to ensure that the highest blood levels of the drug coincide with peak pain and stiffness . A sustained drug delivery system that can be administered at night (before sleep) but that release drug in early morning would be a promising chronopharmaceutic system 4, . Correspondence to Author: