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.
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