APPLICATION OF THE NEW OROSLIPPERY TECHNOLOGY IN THE PREPARATION OF ENTERIC SLIPPERY COATED TABLET OF NAPROXEN

摘要

Objective: The aim of this study was to formulate enteric coated oroslippery tablets (OSTs) of naproxen to overcome the common problems of stomach irritation and swallowing difficulties which accompanied the administration of naproxen tablets. Methods: Different formulas of enteric slippery tablets were prepared by direct compression method. Various parameters were investigated like the effect of eudragit L-100 (eud.) concentration (as an enteric polymer), coating level and effect of different concentrations of croscarmellose sodium CCS (as super disintegrant) on the physical properties. Finally, in an in vitro disintegration and release study was carried out. Results: The enteric slippery optimal formula (F8) was selected to consist of double coat (17.5% eudragit (eud.)) with core tablet containing (6% CCS). It was found that this optimal formula having an acceptable physical property (friability, hardness, thickness and weight variation). Besides, the best acid resistant potential represented by the protection of the OSTs for 2 h in 0.1 N HCl without any sign of disintegration and drug release. Moreover, it was found that (F8) has a disintegration time equal to (8±1.36 min) and release of 80% (20±0.18 min) in phosphate buffer pH 6.8. Conclusion: The result revealed the successful preparation of naproxen tablets using enteric slippery coating that can be easily swallowed and prevent direct irritation of the stomach with acceptable tablet weight.