Formulation and Optimization of Directly Compressible Ambroxol HCl Controlled Release Matrix Tablets

The purpose of this study was to develop controlled release matrix tablets of Ambroxol HCl (hydrochloride) using xanthan gum. The matrix tablets were prepared by direct compression, were subjected to physical characterization and in vitro release studies. The in vitro drug release studies were carried out using USP apparatus 2 at 100 rpm in 900 ml of acidic dissolution medium (pH 1.2) for 2 h, followed by 900 ml alkaline dissolution medium (pH 6.8). Formulation was optimised on the basis of acceptable tablet properties and in vitro drug release. The results of dissolution studies indicated that formulation F-II (drug to polymer 1:0.5), the most success of the study, exhibited drug release pattern very close to the marketed sustained release profile. By applying exponential equation, optimised formula followed korsmeyer-peppas model with non Fickian anomalous transport mechanism.