Abstract

Objective: Naproxen is a non steroid anti-inflammatory drug with analgesic and antipyretic properties. The present study is undertaken with an aim to prepare naproxen as an enteric coated tablet to avoid its gastric irritation effect and evaluated its clinical efficacy. Method: Five formulas of naproxen core tablets were prepared by wet granulation techniques using lactose or starch as diluents, Avecil 102 or Crosspovidone as disintergrants, and P VA either in aqueous or alcoholic solution as binder were used. The flow characteristics of the granules were assessed by determining their angle of repose and Carr’s index. The physicochemical properties of the all prepared tablets as weight variation, hardness, friability, disintegration test, and drug release study were done to select the best formula. The coating mixtures either shellac alone (5 %, 10% and 15%) or shellac -HPMC combination was used to coat the selected formula and evaluate its effect on drug release. In clinical study the selected prepared naproxen tablets with or without enteric coating were given to two groups patients suffering from renal pain, each group of ten patients. Results: The F4 (contain lactose as diluents, binder, and aqueous solution of PVA and Crosspovidone as disintergrants) gave the fast drug release of 98% after 20 min with accepted weight variation hardness, friability, and disintegration time of 25 seconds. In addition to that, the prepared granules gave good flow properties. Moreover, it has been found that 10% shellac- 5% HPMC mixture gave best release for enteric coated naproxen tablet and comports with requirements of drug release targeted for small intestine. The clinical study indicated the effectiveness of the both prepared formulas as pain killer without gastric irritation for enteric coating one.

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