Formulation development and assessment of Naproxen sodium tablet (Anti rheumatic agent)

Abstract

Background: Naproxen sodium has been extensively used as an anti-pyretic, anti-inflammatory and analgesic agent. Naproxen sodium tablet contains non-active ingredients like maize starch, microcrystalline cellulose, cross povidone, cross carmellose, lactose mono hydrate and magnesium stearate

Objective: The objective of the study is to devise a method which caters to diverse aspects such as manufacturing and analysis associated with Naproxen Sodium.. 

Methods: All these non-active ingredients were blend with active using wet granulation technique. Different disintegrating agents were used for the enhancement of dissolution and disintegration property of newly formulated pharmaceutical product. In-process and finished product quality control tests were conduct which include weight variation test, uniformity test, hardness test, disintegration and dissolution test. UV spectrophotometer and HPLC analysis was also performed.

Conclusion:The results were found satisfactory plus the new formulation of naproxen sodium tablet passed the all criteria for analysis as specified in the BP/USP. The percent assay of granules was performed by both techniques that are HPLC and UV spectroscopy. The percent pharmaceutical assay, the individual weights, average weights, thickness, disintegration time of core and coated tablets, hardness and friability of core tablets plus dissolution test of coated tablets met the limits specified in the BP and USP.