FORMULATION AND EVALUATION OF ACECLOFENAC MATRIX TABLETS USING SOLID DISPERSED PRODUCT

Aceclofenac is a non-steroidal anti-inflammatory drug indicated for symptomatic treatment of pain and inflammation. Aceclofenac is a BCS Class II drug with low solubility and high permeability, thus solid dispersion is one of the promising techniques used for enhancement of solubility and dissolution rate. The intent of the present study was to formulate and evaluate aceclofenac matrix tablets by Wet Granulation technique, by partial in-corporation of the solid dispersed product as loading dose and pure drug as maintenance dose; so that the initial loading dose will produce an immediate therapeutic effect and the pure drug will lead to maintaining the concentration within the therapeutic index. Solid dispersions of aceclofenac were prepared by solvent evaporation method by using two different carriers klucel Hydroxy Propyl Cellulose–EXF and Hydroxyl Propyl Methyl Cellulose K-100 M CR by varying the drug and polymer ratios. Aceclofenac matrix tablets were formulated by wet granulation technique and all the formulations were evaluated for pre-compression and post-compression parameters. The granules showed good flow properties. All the formulated tablets were found within the permissible limits for various Post-compression parameters. The drug content and drug release profile were maximum in the SD2 formulation of 1:1 ratio in both pH 1.2 0.1N HCl and 6.8 pH phosphate buffers. The in-vitro drug release of PH4 formulation showed the best release of 96.79 % at 24 hrs. Formulation of aceclofenac matrix tablets using solid dispersed products seems to be a promising formulation for the safe and effective delivery in the treatment of pain and inflammation.