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IJPST-Pharmaceutical Characterization and Assessment.pdf	301.75 KB

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Abstract:

The objective of this study was to develop the extended release tableted matrix devices for once daily dosing of diclofenac sodium, and their evaluation for performance and compliance with official pharmacopoeial and allied pharmaceutical requirements. The matrix tablets were prepared by drug incorporated polymer matrix, formulated using different combinations and ratios of hydroxyl-propyl-methylcellulose (HPMC), sodium carboxy-methylcellulose (Sodium CMC), and sodium alginate (NaAlg). Several preformulation trials were conducted to study the effect and optimization of various formulation and process parameters. The drug loaded polymeric matrices so prepared were compressed to tablets and studied for drug the release behaviour and comparative kinetic characterization along with six popular marketed brands of Diclofenac – SR tablets. Dissolution testing for modeling of drug release kinetics was conducted as per the SUPAC guidelines provided by FDA for modified release dosage forms. The formulated granules and tablets compressed complied with compendial and mechanistic requirements. The in vitro results shown a better release profile of formulated delivery system when compared to marketed brands extended up to 24 hours. The various formulations have shown an extended release up to 11 – 23 hours in different release environments.