Formulation and Development of Dual Release Multiparticulate System for Aceclofenac

Department of Pharmaceutics, Department of Phytopharmacy and Pharmacognosy, JSS College of Pharmacy, Udhagamandalam-643001, Tamil Nadu, India Abstract The objective of present work was to prepare a dual release drug delivery systems comprising fast and delayed release pattern using solid dispersion and pellets of the 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. The prepared solid dispersion was evaluated for percentage yield, drug content and in vitro characterization. Based on In vitro release studies ASD-4(1:4 ratios) batch is chosen as optimized batch and incorporated into dual release capsules of aceclofenac. Aceclofenac pellets were prepared using different concentrations of HPMC by extrusion spheronization technique. Based on In vitro release studies M3 (15%HPMC) batch is 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 (ASD4) with either pellets (M3). The dual released capsules showed a biphasic in vitro release pattern with initial burst release and sustained release following the quasi-Fickian diffusion-based release mechanism. Bioavailability studies for the optimized dual release formulation were carried out to assess the pharmacokinetic parameters. The peak plasma concentration (Cmax) was achieved in 2h . The Cmax of dual release spheroids was found to be greater than that of IR and SR dosage forms indicating that higher plasma concentration could be achieved quicker (2h and 3h spheroids ) 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 spheroids indicating the enhanced absorption of poorly water soluble aceclofenac.