FORMULATION AND EVALUATION OF ACECLOFENAC MATRIX TABLETS

Aim: The concept of sustained release tablet can be utilized to provide a long lasting and more reliable release of drug in GIT to ultimately develop a once daily formulation. Thus, they prolong the dosing intervals, but also increase patient compliance beyond the level of existing conventional dosage forms. Aceclofenac, an analgesic and anti-inflammatory agent is used in the management of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. It is a drug with short biological half-life (4 hrs) and dosing frequency more than one per day which makes it an ideal candidate for sustained release. The present investigation was planned to formulate and evaluate the Aceclofenac once daily sustained release tablets. Methodology: The tablets were p r e p a r e d b y d irect c o m p r e s s i o n meth o d and w e r e subjected for in vitro drug release studies. The mechanism of drug release was determined using various kinetic models. Results: The results revealed that all the formulated tablets had acceptable physical properties and showed release up to 24 hrs. The kinetic studies revealed that all the formulations followed Higuchi matrix model. The formulations were subjected to the comparative study of in vitro drug release with the marketed formulation, the results of which showed that the drug release from the optimized formulation showed comparatively equal to marketed product. Further the stability studies were carried out as per the ICH guidelines for three months proved that the formulated tablets were stable at the accelerated conditions of temperature and humidity. Conclusion: Based on the in vitro results it was concluded that the matrix tablets prepared with HPMC K4M, Acrycoat G971 provided the oral sustained release of Aceclofenac. Key words: Aceclofena