SURFACE RESPONSE METHODOLOGY FOR DEVELOPMENT AND OPTIMIZATION OF NAPROXEN SUSTAINED RELEASE TABLETS

Abstract

Objective: The current work focuses on the development and optimization of Naproxen 800mg sustained release tablets using surface response methodology.

Methods: The drug release was controlled by formulating it into a sustained release tablet. The formulae was developed using various individual concentrations and viscosity grades of HPMC polymers for Naproxen SR tablets. The compatibility of polymers along with pure drug Naproxen was evaluated using FTIR and DSC studies. The tablets were prepared and Pre- and Post-compressional parameters, In-vitro dissolution testing, release rate kinetics and stability studies were evaluated.

Results: The FT-IR and DSC spectras confirms the absence of chemical interaction between drug and polymers. All the Pre-compressional and Post-compressional parameters were found to be in limits. From the dissolution testing of all these formulations the low and high level of polymer concentrations which were within the range of Target product profile was determined. The design space as defined by the above experiments is within 21.3 to 22.8 range of the total polymer concentration. The data for stability studies revealed that no considerable differences in drug content and dissolution rates for a period of 6 months as per ICH guidelines.

Conclusion: Based on the above results, a design space for all the three polymers was successfully developed within which when the tablets are fabricated, the target product profile will always be achieved.

Key-words: Rheumatoid arthritis; Naproxen; Sustained release matrix system; Hydrophilic polymers.