Formulation and development of naproxen tablets

The objective of the study was to develop a formulation for Naproxen tablets by using lactose monohydrate as diluent, different binders such as povidone K-30, povidone K-90, pre-gelatinised starch and disintegrants such as sodium starch glycolate, croscarmellose sodium; and then evaluating Naproxen tablets. There were nine formulations prepared and evaluated formulations were coded Fl, F2, F3, F4, F5, F6, F7, F8 and F9. The study was aimed to develop the formulation of conventional Naproxen tablets. In F9, the concentrations of binders were reduced. The hardness and disintegration were found to be satisfactory and 85 per cent of dissolution was observed only in 30 minutes and tablets disintegrated on an average at one minute 42 seconds and 99.83 per cent of assay was observed with all other parameters satisfactory. To study the reproducibility of this formulation, three more batches of the same composition were prepared and evaluated. In all the three batches, hardness, dissolution and all other parameters were found satisfactory. Hence, it was concluded that F9 was satisfactory and contained naproxen USP (80% w/w), lactose monohydrate (11.6%w/w), croscarmellose sodium (2% w/w), povidone K-30 (1%w/w), pregelatinised starch (2%w/w), magnesium stearate (0.4%w/w) and colloidal silicon dioxide (1% w/w). The tablets were prepared by using punch size 9mm flat bevelled using cadmach 16-station compression machine. A rapid mixer granulator was selected for wet granulation. Accelerated stability testing was done as per the ICH guidelines and successful formulation was found highly stable in all respects.