Abstract

FORMULATION AND EVALUATION OF SUSTAINED RELEASE TABLET OF ACEBROPHYLLINE

Abhinav Shahi*, Dharmendra Kumar

Abstract

In the present study development of a polymer-based matrix tablet was undertaken to produce a sustained-release dosage form of Acebrophylline, since this dosage forms is relatively simple and cheap to produce when compared to other. Different batches of drug Acebrophylline tablets were manufactured by wet granulation technique, and evaluated for Pharmacopoeial and non-Pharmacopoeial specifications. Dissolution testing was undertaken using USP Apparatus 2 (Paddle Type), which allowed for a more realistic assessment and prediction of in vitro drug release rates. Samples were analysed using a high performance liquid chromatographic method (HPLC). Formulation F5 shows optimum drug release. Drug and rate retarding polymers ratio used in this formulation were Methocel K100 LV (14.86% w/w) and Methocel K4M (10.14%w/w), in ratio (5.4:1.34:1). The results of in vitro drug release studies were treated with zero order, first order kinetics, Higuchi, Hixon-Crowell and Korsemeyer‐Peppas model. In our experiments, the in‐vitro release profiles of drug from all the formulations could be best expressed by Higuchi’s equation, as the plots showed high linearity (r2= 0.972 to 0.999 ) to confirm the diffusion mechanism. The data were fitted into Korsemeyer‐Peppas model. All formulations F1 to F6 showed high linearity (r2= 0.969 to 0.998), with slope (n) values ranging from 0.383 to 0.683. This indicates that F1,F2 and F3 shows purely diffusion and F4, F5 and F6 shows coupling of diffusion and erosion mechanism so called anomalous diffusion. Stability testing was carried out at 400C ± 20C/75% ± 5% and 250C ± 20C/ 60% ± 5% and indicated that the product was stable.

Keywords: Acebrophylline, Methocel K100 LV, Methocel K4M, Higuchi’s equation, First order kinetics.