Application of Aceclofenac Solid Dispersion to Tablet Formulation and Manufacturing using Crosspovidone and Pvp-K 30 as Dissolution Enhancing CarriersAuthor(s): Thiyagarajan Ayyappan, Thangarasu Vetrichelvan and Sabarimuthu Darlin Quine
The objective of the present study is to develop solid dispersion tablet formulation of aceclofenac, a novel non steroidal anti inflammatory drug, mainly used for rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. The major problem with this drug is its very low solubility in biological fluids, which results in poor bioavailability after oral administration. Therefore, solid dispersion of aceclofenac with crosspovidone and polyvinyl pyrolidone K-30 were prepared with a view to increase its water solubility. Aceclofenac solid dispersion with crosspovidone showed maximum drug release and hence, the tablet formulation containing aceclofenac, crosspovidone and polyvinyl pyrolidone K-30 solid dispersion, was prepared with a view to improve its water solubility. The dissolution profile of best laboratory developed formulation (F-III) was compared with marketed tablet product. The drug release profile was studied in 2 % w/v sodium lauryl sulphate in distilled water. F-III gave far better dissolution than other laboratory developed formulations. The dissolution efficiency of FIII was compared with pure drug, conventional tablets. F-III showed maximum dissolution efficiency. FIII was considered better than the conventional tablet, as far as the cost of raw materials used in the product is concerned. F-I to F-IV were subjected to stability studies. The formulation was found to be stable for 30 days at 40° C ± RH 75 % as per ICH guidelines, with insignificant change in the hardness, disintegration time, and in vitro drug release pattern.