Authors: Samra Rumman, T. Vijay Kumar, Md. Munawar Ali Khan, G. Sridhar Babu and Syed Muzammil Afzal*
The aim of the study was to develop extended release Tapentadol Hydrochloride tablets by thermal sintering technique. Different formulations of Tapentadol Hydrochloride sintered tablets were prepared using sustaining polymer-eudragit RL-100, sintering waxes-stearic acid and carnauba wax, disintegrating agent-microcrystalline cellulose, glidant-talc and lubricant-magnesium stearate by direct compression method. The prepared tablets were exposed to temperatures 400 C and 600 C to sinter at three different time durations of 1, 2 and 3 hours. The powder blend of different formulations was evaluated for drug excipient compatibility studies (FTIR, DSC) and pre compression studies. The sintered tablets were also evaluated for post compression studies, in-vitro drug release studies, kinetic studies and stability studies. FTIR and DSC showed no interaction between drug and excipient. The pre compression and post compression studies results were found to be within the limits. The drug release from optimized formulation (F17-Tapentadol Hydrochloride with stearic acid and carnauba wax sintered at 600C for 2 hours) was found to be 100.38% in 12 hours. The drug release followed nearly zero order release and indicated super case II transport mechanism. Stability studies revealed that optimized formulation was stable at 40±2°C and 75±5% RH for 3 months. Thus, the developed F17 formulation by sintering technique has great future potential to be prepared as sustained release tablets.
Download Article: Syed Muzammil Afzal, Int.J.A.PS.BMS,2017,Vol.6(1) 001-021