Formulation, Development, and Evaluation of Sustained Release Tablet of Ambroxol Hydrochloride

Abstract

Introduction: Ambroxol hydrochloride tablet was formulated as sustained release tablets employing rice bran wax
polymer and the sustained release behavior of the fabricated tablets were investigated. Materials and Methods: The
objectives of study are Sustained release matrix tablets containing 75 mg ambroxol hydrochloride were developed
using different drug polymer ratios of MCC, RBW and DCP. Tablets were prepared by direct compression.
Formulation was optimized on the basis of acceptable tablet properties and in vitro drug release and by using
23 factorial designs. Result and Discussion: The resulting formulation produced robust tablets with optimum
hardness, consistent weight uniformity and low friability. All tablets but one exhibited gradual and near-completion
sustained release for ambroxol hydrochloride, and 98-103% released at the end of 8 h. Conclusion: The results of
dissolution studies indicated that formulation F7, the most successful of the study, exhibited drug release pattern
very close to theoretical release profile. A decrease in release kinetics of the drug was observed on increasing
polymer ratio. Applying exponential equation, all the formulation tablets (except F7) showed diffusion-dominated
drug release. The mechanism of drug release from F7 was diffusion with erosion.