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

Abstract

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.

Preparation and Evaluation of Highly Drug-Loaded Fine Globular Granules Using a Multi-functional Rotor Processor

“…Korakianiti et al demonstrated that the final product properties of the granules could be affected by the rotating speed used for fluid bed rotogranulation, although the precise nature of the properties would be dependent on the formulation and manufacturing methods used during the granulation process. 13) Taken together, the results of our current and previous studies of the GX system demonstrate that the final product properties could be affected by the rotating speed, although the extent of these effects would be dependent on the formulation and the manufacturing methods used during the granulation process. As shown in Table 4, the water content increased as the liquid binder flow rate (X 1 ) (p<0.001) increased or the atomization pressure (X 2 ) (p=0.006) or rotating speed (X 3 ) (p=0.002) decreased.…”

Response surface methodology for optimization and characterization of limonene-based coenzyme Q10 self-nanoemulsified capsule dosage form

“…Different types of screening designs, such as fractional factorial and Plackett-Burman screening designs, have been used for preformulation evaluations. [7][8][9][10] Response surface methodology (RSM) is used when only a few significant factors are involved in optimization. Different types of RSM designs include 3-level factorial design, central composite design (CCD), 11,12 BoxBehnken design, 13 and D-optimal design.…”

Preparation and evaluation of enteric-coated delayed-release pellets of duloxetine hydrochloride using a fluidized bed coater

“…The type of coating technique strongly affects the film microstructure and thus affects the release mechanism and rate from pellets coated with polymer blends (Lecomte et al 2004). Pellets have increased in importance over the years due to their distinctive advantages in both technological and therapeutic aspects (Korakianiti et al 2000). When administered orally, therapeutic advantages include modification of drug release, division of dose strength, and free dispersion in the gastro intestinal tract (Abdul et al 2010).…”