Abstract

Background: Diclofenac sodium (DS) is a non-steroidal anti- inflammatory drug (NSAIDs) that has strong anti-inflammatory and analgesic effects, but it has many serious side effects on the gastrointestinal tract. Enteric-coated DS pellets have many advantages such as limited drug release in the stomach, with Eudragit L100 coating to help drug release in the intestines, avoiding side effects in the gastrointestinal tract. The aim of this study was to formulate enteric-coated pellets and to evaluate the physico-chemical properties of prepared pellets. Materials and methods: DS, HPMC, Eudragit L100 were used in this study. DS pellets were prepared using sugar spheres layered with DS followed by an enteric coat of Eudragit L100. Results: Prepared enteric-coated DS pellets by layering method using HPMC as a binding agent and Eudragit L100 as enteric-coated membrane to help pellets ensure the release of drug in the gastrointestinal tract. Pellets have a nice shape, the size range of 0.7-1 mm, the layering efficiency of 36.69%, the drug content of 8.84% ± 0.43% (w/w). The drug release was 3.59% after 2h in acidic environment of pH 1.2 and 84.9% after 1h in phosphate buffered saline of pH 6.8. Conclusions: Enteric-coated pellets of DS were successfully prepared by using coating technology.