Effect of Amount of Added Water During Extrusion-Spheronization Process on Pharmaceutical Properties of Granules

Abstract

AbstractIn order to clarify mechanism of spherical granulation using a spheronizer and its pharmaceutical properties, crystalline lactose, corn starch and theophylline were used as pharmaceutical powders, with an aqueous solution of hydroxypropylcellulose as a binder. The granules were prepared by extruding wet masses containing various amounts of water (150, 200 and 250 ml/kg). They were treated in a spheronizer for 0–10 min, and dried at 60°C for 12 min in a fluidized-bed dryer. The elongation ratio was used as an index of spheronization, and the arithmetic mean granules diameter were used as mean daimeter. The elongation ratio of the granules decreased from 5–8 to around 1.5 after 2-min spheronization. The angle of repose of spheronized granules was lower than that of the intact granules, suggesting that they had better flowability. The yield of granules obtained from addition of 250 ml/kg of water was much higher than that by adding 150 ml/kg of water, indicating that the former had a larger mean part...