Optimization of the pelletization process in a fluid-bed rotor granulator using experimental design

• Published in: AAPS PharmSciTech 2000-12, Vol.1 (4), p.E35-75
• Main Authors: Korakianiti, E S, Rekkas, D M, Dallas, P P, Choulis, N H
• Format: Article
• Language: English
• Subjects: Drug Compounding - instrumentation; Drug Compounding - methods; Drug Compounding - statistics & numerical data; Drug Implants - chemistry; Drug Implants - metabolism; Equipment Design - statistics & numerical data; Equipment Design - trends; Reproducibility of Results; Research Design - statistics & numerical data; Technology, Pharmaceutical - instrumentation; Technology, Pharmaceutical - methods; Technology, Pharmaceutical - statistics & numerical data
• ISSN: 1530-9932; 1530-9932
• DOI: 10.1208/pt010435

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