Development of Diclofenac 12H Sustained Release Tablets From Hydrophilic Polymers

Abstract

The objective of this study was to develop six formulation for a sustained release Diclofenac 12 hour by direct compression method. In the designing of SR product the polymer played role which regulated drug release for stipulated period. Various ratios of two different hydrophilic polymers (Methocel Kl5M Premium and Methocel K100 LV CR premium were incorporated. Drug content in the proposed fonnulations (F -1-F -6) were 47.61 %, 43.63%, 43.63%, 43.63%, and 48% respectively and drug-polymer ratio has directly influence steady state drug release from the matrix. Formulations (F-l, F-2, F-4 and F-5) did fulfill the official drug release for 8 hours. Moreover F-3 and F-6 showed standard release in vitriol than aforementioned formulation in buffer medium for 12 hours using USP reference dissolution apparatus. Physical criteria of formulation (F-l - F-6) like loose bulk density 0221±0.02 to 0.521±0.01), tapped bulk density (0.327±0.02 to 0.457±0.03), comprehensibility index (l1.l5±0.03 to 13.35±0.02), total porosity (26.l9±0.04 to 34.56±0.01), angle of repose CL53±0.01 to 29.36±0.01), hardness (3.19±0.01 to 4.35±0.03), friability (0.0 to O.l2±0.02), llaickness (4.19±0.12 to 4.90±0.03) and weight variation test (1.132±0.02 to 2.903±0.23) were C'\-aluated. The drug release profile was extrapolated by zero order release kinetics, first order release kinetics, Higuchi release kinetics and Hixson-Crowell release kinetics. This study gives idea on how the release pattern of granules and tablets altered upon the changing of polymer ratio.