Development and Optimization of Naproxen Sodium Controlled Release Tablets: QbD Approach

Objectives: The aim of present study was to formulate and optimize Multi-unit Naproxen Sodium controlled release tablet by QbD approach. Controlled release dosage form for naproxen sodium was selected to reduce dosing frequency and gastrointestinal side effects of drug. Methods: Naproxen Sodium CR tablets were prepared by using wet granulation method by employing Quality by Design (QbD). This tablet was made by a mixture of a granulate having an immediate release with a granulate having a controlled release, in terms of the active ingredient. Eudragit RSPO and RLPO polymers were used to control the drug release. Optimization of tablet formulation was done using 23 factorial design to study the effect of concentration of Eudragit RSPO, Eudragit RLPO polymers and concentration of disintegrating agent i.e. crospovidone on disintegration time and f2 factor of drug released. Tablets were evaluated for thickness, hardness, friability, assay and drug release. Results: Optimized formulation shows controlled drug release profile upto 14 hrs. with disintegration time of 88 min. Conclusion: It was concluded that tablet formulation of Naproxen Sodium CR tablets employing QbD leads to a single dose per day in the management of rheumatoid arthritis and also concluded that Eudragit RLPO and Eudragit RSPO polymers can be successfully used to controlled drug release profile of tablet.