Optimization of the pelletization process in a fluid-bed rotor granulator using experimental design.
This study examined the effect of rotor speed, amount of water sprayed, and atomizing air pressure on the geometric mean diameter and geometric standard deviation of pellets produced in a fluid-bed rotor granulator using a 23 factorial design and an optimization technique. Pellets were prepared by wet granulation. Equal amounts of microcrystalline cellulose, alpha-lactose monohydrate, and distilled water were used as the granulation liquid. The size and the size distribution of the pellets were determined by sieve analysis. The size of the pellets was found to be dependent on the amount of water added, while an increase in rotor speed decreased their size. Both factors were found to be statistically significant (P <.05). The effect of atomizing air pressure on pellet size was not statistically significant. None of the 3 factors significantly affected the geometric standard deviation of the pellets. The rotor speed and the amount of water sprayed were further selected in order to construct a mathematical model that correlates these factors with the geometric mean diameter of the pellets. For this purpose, the optimization technique 3(2) was used. The derived equation described the relationship between the selected factors and the size of the pellets. As a result, the experimental design techniques applied were found to be suitable in optimizing the pelletization process carried out in a fluid-bed rotor granulator.
Korakianiti
E S
ES
Division of Pharmaceutical Technology, School of Pharmacy, University of Athens, Panepistimiopolis, Zografou, Athens 157 71, Greece.
Rekkas
D M
DM
Dallas
P P
PP
Choulis
N H
NH
D004339:Drug Compounding / Q000295:instrumentation* / Q000379:methods* / Q000706:statistics & numerical data; D004343:Drug Implants / Q000737:chemistry / Q000378:metabolism*; D004867:Equipment Design / Q000706:statistics & numerical data / Q000639:trends; D015203:Reproducibility of Results; D012107:Research Design / Q000706:statistics & numerical data; D013678:Technology, Pharmaceutical / Q000295:instrumentation* / Q000379:methods* / Q000706:statistics & numerical data
D004343:Drug Implants