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FORMULATION DEVELOPMENT AND CHARACTERIZATION OF PIROXICAM PULSATILE RELEASE TABLETS CONTAINING HYDROXYL PROPYL CELLULOSE AND ETHYL CELLULOSE

The main aim and objective of present investigation was to formulate and evaluate pulsatile tablets delivery system for Anti-inflammatory drugs like piroxicam. Chrono modulated drug delivery systems release the drug at predetermined lag time in cardiovascular disorders, diabetes, asthma, rheumatoid arthritis, ulcers. Piroxicam is a non steroidal antiinflammatory drug used in treatment of rheumatoid arthritis. Pulsatile tablets consist of core and coat layers. Core tablets of piroxicam were prepared using various super disintegrants like Ac di sol and sodium starch glycolate using direct compression method. The core tablets were then press coated with release rate retarding polymers to release the drug in early morning hours after predetermined lag period. Hydroxyl propyl cellulose and Ethyl cellulose were used as release rate retarding polymers. FTIR studies were conducted to know the interaction between drug and excipients. Evaluation tests like hardness, thickness, friability, weight variation, disintegration time and dissolution tests were carried out for compressed tablets. Dissolution tests were conducted in 0.1 N HCL acidic buffers for 120 minutes and in phosphate buffer pH 6.8 for remaining 6 hours in USP dissolution apparatus. Core tablets of pc-15 initially released 85.89% drug in 60 minutes and press coated tablets released 94.85 % drug after 8 hours. Accelerated stability studies were carried out for 90 days. Formulation PC-15 of piroxicam containing Ac di sol and Explotab as super disintegrant and Hydroxyl propyl cellulose and Ethyl cellulose as rate controlling polymers has shown better micromeritic properties, less weight variation, high drug content, better hardness, less friability, quick disintegration time and dissolution profile among all the formulations. Hence formulation PC-15 is chosen as best optimized formulation after carrying out all evaluation tests.

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