Korakianiti E S, Rekkas D M, Dallas P P, Choulis N H
Division of Pharmaceutical Technology, School of Pharmacy, University of Athens, Panepistimiopolis, Zografou, Athens 157 71, Greece.
AAPS PharmSciTech. 2000 Dec 1;1(4):E35. 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 <.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.
本研究采用23析因设计和优化技术,考察了转子速度、喷水量和雾化气压对流化床转子制粒机所制颗粒的几何平均直径和几何标准差的影响。颗粒通过湿法制粒制备。等量的微晶纤维素、α-乳糖一水合物和蒸馏水用作制粒液。颗粒的大小和大小分布通过筛分分析确定。发现颗粒大小取决于加水量,而转子速度的增加会使其尺寸减小。这两个因素在统计学上均具有显著意义(P<.05)。雾化气压对颗粒大小的影响在统计学上不显著。这三个因素均未对颗粒的几何标准差产生显著影响。进一步选择转子速度和喷水量,以构建将这些因素与颗粒几何平均直径相关联的数学模型。为此,使用了优化技术3(2)。导出的方程描述了所选因素与颗粒大小之间的关系。结果表明,所应用的实验设计技术适用于优化流化床转子制粒机中的制粒过程。