The objective of present study was to formulate and evaluate ambroxol hydrochloride sustained release pellet by extrusion spheronization technique for minimize fluctuation in plasma drug concentration with better patient compliance. Sustained release pellets prepared using xanthan gum and guar gum in different concentration. In 32 factorial designs xanthan gum (X1) and guar gum (X2) were selected as independent variables and drug release in two hrs (Q2) (Y1) and Q12 (Y2) were dependent variables. All formulations were evaluated for angle of repose, bulk density, tapped density, carr’s index, % friability, % yield, drug content and drug release. Optimized formulation was evaluated for one month stability study. The optimization study indicates that % drug release in 2 hrs (Q2) and in 12 hrs (Q12) depends on concentration of xanthan gum and guar gum. Regression analysis and analysis of variance were performed for dependent variables. Formulation F4 containing 5% of xanthan gum and 15% of guar gum was optimized. It showed 32.79% drug release in two hrs and 98.67% drug release at 12 hr. The studies indicate that the sustained release pellets can be efficiently formulated for ambroxol hydrochloride by extrusion spheronization. The optimized formulation was subjected to stability studies for one month at 40°C temperature with RH 75±5% and showed there was no significant change in drug content, physicochemical parameters and release pattern.
Loading....