Design Formulation and Evaluation of Diclofenc 12H Sustained Release Tablets from Methocel K 15 MCR and Methocel K 100 LVCR

Abstract

The aim of the study is to design, formulation and evaluation of sustained release diclofenac tabler, prepared by direct compression method. The polymers played vital role in the designing of SR product. In this study, six formulations (F-l - F-6) were prepared by using two different hydrophilic polymers Methocel K15M Premium and Methocel KlOO LV CR Premium which were acted as matrix. Physical criteria of formulations (F-l - F-6) like loose bulk density ,O.221±O.02 to O.521±O.Ol), tapped bulk density (O.327±O.02 to O.457±O.03), compressibility mdex (11.15±O.03 to 13.35±O.02\ total porosity (26.19±O.04 to 34.56±0.01), angle of repose 21.53±0.01 to 29.36±O.0l), hardness (3.19±0.01 to 4.35±0.03), friability (0.0 to O.12±0.02), thickness (4.19±0.12 to 4.90±O.03) and weight variation tes1 (1.132±O.02 to 2.903±O.23) were evaluated for the formulations (F-l - F-6). The drug content in the proposed formulations (F-I-F-6) were 47.61%, 47.61%,43.63%,43.63%,43.63%, and 48% respectively and drug-polymer ratios 11 :5,3:4,2:5,4:3,3:3 and 3:5) respectively has directly influenced steady state drug release from the matrix. Formulations (F-3 and F-6 ) showed standard release in vitro than any other in buffer medilLtn for 8 hours using USP reference dissolution apparatus. On the Other hand formulations (F-l, F-2, F-4, and F-5) did not fulfill the official drug release for 8 hours. 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 .