FORMULATION AND DEVELOPMENT OF DUAL RELEASE MULTIPARTICULATE SYSTEM FOR ACECLOFENAC
The objective of present work was to prepare a dual release drug delivery systems comprising fast and delayed release pattern using solid dispersion and minitablets of aceclofenac to achieve a desired in vitro and in vivo profile. Aceclofenac solid dispersions were prepared by solvent evaporation method using PEG 6000 as carrier at different ratios. Based on the In vitro release studies the formulation ASD-4(1:4 ratios) batch was chosen as optimized batch and incorporated into dual release capsules of aceclofenac. Aceclofenac mini tablets were prepared using different concentrations of HPMC. Based on the in vitro release studies formulation contain 40% HPMC batch was chosen as optimized batch and incorporated into dual release capsules of aceclofenac. The dual release dosage forms were constructed incorporating the optimized batch of solid dispersion with mini tablets. The prepared dual release dosage form was evaluated for their in vitro and in vivo drug release. The dual released capsules showed a biphasic in vitro release pattern with initial burst release and sustained release following the quasiFickian diffusion-based release mechanism. It was observed that the developed dual release matrix tablets and pellets follow first order kinetics obeying fickian diffusion. Bioavailability studies for the optimized dual release formulations were carried out to assess the pharmacokinetic parameters. The peak plasma concentration (Cmax) was achieved 3h for mini matrix tablets. The C max of dual release mini matrix tablets was found to be greater than that of IR and SR dosage forms indicating that higher plasma concentration could be achieved quicker (3h) than the SR formulation (6h). Thus the absorption lag time associated with SR formulations could be minimized using these formulations. Further, there was significant increase in AUC 0-α in case of dual release mini matrix tablets than the IR and SR indicating the enhanced absorption of poorly water soluble aceclofenac