Formulation and Evaluation of Aceclofenac Loaded Sr Matrix Pellets: Extrusion Spheronization

Objective: The major objective of this study was to prepare and evaluate OnceDaily Sustained Release Matrix Pellets Formulation of Aceclofenac by using Extrusion-Spheronization technique. Methods: The sustained release matrix pellets of Aceclofenac were prepared by industrially applied extrusion spheronization technique. The different formulations were prepared using HPMC K100M LVCR as hydrophilic matrix polymer , PEG 400 as potential plasticizer in different concentration, MCC PH101 as a spheronization aid and HPMC K4M (2% w/w) as binder. The prepared pellets were evaluated for parameters like Flow Properties, Morphological characteristics, Drug Content and In vitro drug release study in pH 6.8 phosphate buffer. Experimental design technique was used to select optimized formulation releasing drug for 24 hr. Results: The Aceclofenac SR matrix pellets composed of HPMC K100M LVCR 11 % and PEG 400 3 % was selected as optimised. The evaluated parameters of optimised batch were found within the limits. Drug release of optimized batch (F3) at 2 hr was found to be less than 30 % (25.43 %) and at 24 hr more than 80 %( 98.32%). Conclusion: The results from this study showed that combination of HPMC K100M LVCR as hydrophilic matrix polymer and PEG 400 as potential plasticizer is effective and useful for sustaining the Aceclofenac release. And hence Extrusion-Spheronization technique can be promising approach for the preparation of pellets which assure its applicability for large scale manufacturing.