Lütfi GENÇ*,?, Naser ESKANDARNEZHAD*

*Anadolu University, Faculty of Pharmacy, Department of Pharmaceutical Technology, 26470 Eskişehir, TURKEY.
oCorresponding author

Summary:
Naproxen sodium (NS) has analgesic, antipyretic and anti-inflammatory activity. It is rapidly absorbed after oral and rectal administration. It is a nonsteroidal anti-inflammatory (NSAI) drug and it is a derivative of phenyl propionic acid. The aim of this study is to prepare film coated tablets of NS to decrease its adverse effects in the gastrointestinal system. Core tablets (CoT) were prepared by direct compression technique. Hardness, disintegration control, weight deviation, friability, in-vitro dissolution test and content uniformity of the active substance were performed in core tablets. Apparatus II (USP 24) in dissolution test and UV spectrophotometric method for the assay of the active substance were used. Spray technique was used to prepare enteric coated film tablets of NS. Eudragit L 100-55, S100, L100 were used in different concentrations as coating materials. PEG 4000 was chosen as plastifier. Assay method was validated. Film coated tablets did not disintegrate in simulated gastric medium (SGM) (pH 1.2) for about 2 hours, but they disintegrated in simulated intestinal medium (SIM) in 20-30 minutes. Approximately 50-97 % NS was dissolved in SIM (pH 7.4) in 55 minutes.