چكيده به لاتين
Triamterene - H granulation is a multistage process included binder preparation, internal phase in high shear mixer, fluid bed drying, milling, external phase and final mixing. Optimization of this process is important with respect to desirability of the final product specification, minimum energy consumption and low waste products. in this research, optimization is done in three steps including formulation, pilot and final production phase. Design of experiments has been done based on selective levels of process variables with full factorial method. There were 32, 8 and 4 tests in formulation, pilot and production phase stages, respectively. According to pharmaceutical standards, the results of physical and chemical tests performed on the granule and tablet samples were recorded in the relevant data sheets. At the end of the formulation and pilot stages, optimum levels of operation variables were specified by analyzing the results of experiments, and these levels were selected for the production phase after verifying the repeatability of the results. considering the significant increase in material volume within the production phase, in addition to operations feasibility using optimal levels of previous two steps, more investigations have been done on mixing operational variables. finally, the feasibility and repeatability of the production phase process were confirmed using the final results of the pilot stage. Optimal operating variables of granulation have been found as water-to-binder ratio= 19, material residence time in granulator = 60 s, speed of the impeller =130 rpm, speed of the chopper = 1000 rpm, drying time = 100 min, drying temperature = 45°C, mesh size of sieve = 18, and final mixing time = 20 min.
Keywords: Granulation; Operation variables; Process optimization; Design of Experiments; Triamterene-H.
