END POINT STUDY ON WET GRANULATION USING HIGH SHEAR SUPER MIXER GRANULATOR

• Main Author: Belami, Dani
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/78610
• Institution: Institut Teknologi Bandung

Background and Objective: To produce good granules quality, the proper time to stop granulation process (endpoint) is has to be determined. Wet granulation, as a most widely method used in the pharmaceutical industry, can be optimized with an approach of formula and process parameters. The objective of this study was to obtain a wet granulation endpoint using High Shear Super Mixer granulator machine, so that granules with the expected physical characteristics can be achieved through a series of evaluation methods such as density, particle size, shape, cohesiveness and flow property tests. Methods: The study was conducted using a high-shear super mixer granulator machine. The formula used was containing lactose (SL) as filler, starch as desintegrant, povidone (PVP) as binder, and water as binding solvent. The experiment began with granulation process using various water concentration of 14%, 16%, 18%, and 20% of the total starting material mixture as binding solvent with massing time of 7.5 minutes, 9.5 minutes, 10 minutes, 1 1.5 minutes, 15 minutes, and 20 minutes. The dry mass was inserted into the vessel of high-shear super mixer, then stirred dry for 5 minutes. Furthermore, liquid binder was added into the dry mass under stirring with impeller and chopper at a constant speed of 140 RPM and 3000 RPM respectively. The granulation end point was evaluated through several parameters such as electricity gurrents during granulation, lost on drying, density, Carr index/compressibility, flow property, average diameter, particle size distribution, penetration depth (granule cohesiveness), morphology and degree of roundness. Results: The measurement of the electricity current for all the mixing time and formula did not show significant differences. The result of granule quality for each formula that obtained by varying different water concentration and massing time, lied in 1.400 to 1.792 g/ml for density value, 470.3 to 663.2 um for average particle diameter value, 10.9 to 3 mm for penetration depth value, 2.38 to 1.13 for DC (distribution criterion) value and 0.579 to 0.795 for degree of roundness value. It was observed that the formula containing 18% concentration of water after mixing of 11.5 minutes (massing time) gave the optimum value for all measurement with 1.792 g/ml for density, 663.2 pm for average particle diameter, 3 mm for penetration depth, about I .13 to 1.22 for distribution criterion (DC) and 0.795 for the degree of roundness. Conclusions: The formula containing concentration of water after mixing of 1 1.5 minutes (massing time) gave the optimum value for all measurement.