Physical Assessment and formulation development of Dome Matrix Controlled Release tablet of Diclofenac Sodium

Abstract

In the last fifteen years where have significant acceleration in drug delivery research. In the early days of controlled release, development of pharmaceutical formulations was more idealized, with emphasis on the attainment of the illusive “zero-order release behavior”. When analyzing the swelling and release behavior of the Dome Matrix systems, it was demonstrated that the swelling behavior of the curved surfaces of the matrices strongly affected the drug release kinetics. The controlled release Dome matrix tablets containing Diclofenac sodium were prepared using a wet granulation process and polymers used xanthan gum, HPMC and Eudragit. Two different formulations were prepared; in first formulation the ratio was kept 60% active ingredient and 40% polymers subsequently in 2nd formulation 55% active ingredient 45% polymers. Precompression test angle of repose, Hausner’s ratio, Bulk Density, Tapped Density, Car’s Index were checked according to the specified standard procedure. All Physical Characteristics of dome tablets were analyzed. Drug release pattern was also analyzed by using USP apparatus II paddle method. The hardness, weight fluctuation, thickness, friability, drug content homogeneity, and in-vitro dissolution investigations of the manufactured controlled release tablets. All were examined and found within acceptable range. The F1 and F2 formulations performed well in tests and had a continuous drug release. The findings of this study showed that a polymer could be successfully used to formulate Diclofenac sodium Dome matrix tablets. The drug release was extended for 8 to 12 hours in all formulations using a drug to polymer ratio of 60:40, 55:45. The formulations are proved to have efficient drug release time. Keywords: Diclofenac sodium, Dome Matrix, Eudragit, Control release, Xanthan gum.