Bioavailability & Bioequivalence: Pharmaceutical R & D Summit

Biography

Biography: Barkat Ali Khan

Abstract

Aims: This study was conducted to prepare modified release Diclofenac potassium loaded ethyl cellulose micro particles.

Methods: 13 trail formulations were studied to form an optimized formulation. Non-solvent addition coacervation method was used for the preparation. Response Surface Methodology (RSM) was applied for modified release formulation optimization. Solid state study was conducted for optimized formulation both qualitatively and quantitatively.

 Results: As the polymer concentration (X1) and stirring speed (X2) increases Entrapment efficiency (Y3) also increases. Stirring speed (X2) has great effect over particles size (Y4). As polymer concentration (X1) and stirring speed (X2) increases compressibility index (CI:Y5) also increases. Optimized formulation was selected from 30 predicted values. Polymer concentration (X1) for optimized formulation was 1.96gm and stirring speed was 602rpm. Characterization study of modified formulation of Diclofenac potassium were given as; %DR after 1^st hour (Y1) was 29.793%,  % DR after 7^th hr (Y2), E.E(Y3) was 94.511%, particle size was 343.70µm and CI (Y5) was 13.46%. In vitro dissolution study showed sustained release for 12 hrs. Kinetic study showed high R² values for zero order (0.9318) and Higuchi model (0.9962). Both qualitative and quantitative analysis proved the stability of optimized micro particles.

Conclusion: SEM showed that particles of optimized formulation were nearly spherical, light yellowish in colour, and having porous and rough surface entrapping drug crystals. Fourier transform spectrophotometry showed that drug is stable in polymer and having no interactions, X-rays powder diffraction (XRD) showed decrease in crystallinity of Diclofenac Potassium in optimized formulation and differential scanning calorimetry (DSC) proved the thermal stability of formulation.