Preparation and Evaluation of Diclofenac Sodium Controlled Release Tablets using Spray-Drying Technology in Aqueous System

摘要

Diclofenac sodium is one of the most widely used NSAIDS and its short half-life of 1-2 h necessitates preparation of a controlled release formulation. Spray drying, a one step process establishes intimate contact of the drug with the polymer and finds increasing applications in the area of controlled release formulations. Eudragit NE 30D is reported to be useful for preparation of controlled release formulations. An attempt has been made to prepare microparticles of diclofenac sodium with Eudragit NE 30D, using spray-drying technology in aqueous system. Aerosil was found to overcome the tackiness caused by Eudragit NE 30D and improved yield and flowability of the product, while talc did not overcome tackiness and did not prove to be suitable excipient. The microparticles were evaluated for percent yield, average particle size and flowability and were compressed into tablets. The tablets were studied for drug assay and dissolution profiles. The tablets containing drug polymer ratio of 1:1.212 were found to release the drug at the rate of 9.3 mg/h over the period of 10 h.