Development and characterization of orodispersible tablets of aceclofenac by sublimation technique

The purpose of this investigation was to develop fast dissolving tablets of aceclofenac using camphor as a subliming agent. Orodispersible tablets of aceclofenac were prepared by wet granulation technique using camphor as subliming agent and sodium starch glycolate together with crosscarmellose sodium as superdisintegrants. Camphor was sublimed from the granules by exposing the granules to vacuum. The porous granules were then compressed in to tablets. Alternatively, tablets were first prepared and later exposed to vacuum. The formulations were evaluated for weight variation, hardness, friability, drug content, wetting time, in vitro and in-vivo dispersion, mouth feel and in vitro dissolution. All the formulations showed low weight variation with dispersion time less than 55 seconds and rapid in vitro dissolution. Sublimation of camphor from tablets resulted in superior tablets as compared with the tablets prepared from granules that were exposed to vacuum. The results revealed that the tablets containing subliming agent had a good dissolution profile. The drug content of all the formulations was within the acceptable limits of the United States Pharmacopoeia XXVII. The optimized formulation showed good release profile with maximum drug being released at all time intervals. It was concluded that fast dissolving tablets with improved aceclofenac dissolution could be prepared by sublimation of tablets containing suitable subliming agent. This work helped in understanding the effect of formulation processing variables especially the subliming agent on the drug release profile. The present study demonstrated potentials for rapid absorption, improved bioavailability, effective therapy and patient compliance.