Formulation Design and Optimization of Sustained Release Tablet of Ambroxol hydrochloride
Keywords:
Ambroxol hydrochloride, HPMC K15M, Eudragit RSPO, Direct compression, Factorial designAbstract
A sustained release matrix formulation for Ambroxol hydrochloride was designed and developed to achieve a 12 h release profile. Using HPMC K15M and Eudragit RSPO as an inert matrix forming agent to control the release of Ambroxol hydrochloride. The matrix tablets for these formulations were prepared by direct compression and their in-vitro release tests were carried out for a period of 12 hours using USP dissolution test apparatus (type I- Basket) at 37±0.5°C and 100 rpm speed. A 32 full factorial design was used for optimization by taking the concentration of HPMC K15M (X1) and Eudragit RSPO (X2) were selected as independent variables, where as initial release at the 2 hrs (Y1, % drug release), release rate at the 8 hrs (Y2, % drug release) and the concentration of Ambroxol hydrochloride released in 12 hrs (Y3, % drug release) were chosen as dependent variables. The optimized formulation F4 follows Hixon Croswell order release kinetics with nonFickian diffusion mechanism. From the study, it was concluded that the release of Ambroxol hydrochloride can be effectively sustained using combination of HPMC K15M and Eudragit RSPO.
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