Study growth kinetics in fluidized bed granulation with at-line FBRM

被引:73
作者
Hu, Xinhui [1 ]
Cunningham, John C. [1 ]
Winstead, Denita [1 ]
机构
[1] Johnson & Johnson Pharmaceut Res & Dev, Pharmaceut Dev, Spring House, PA 19477 USA
关键词
fluidized bed granulation; FBRM; granule growth; particle size distribution;
D O I
10.1016/j.ijpharm.2007.06.043
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
In this study, a novel at-line focused beam reflectance measurement (FBRM) technique was developed to investigate granule growth in a fluidized bed granulation (FBG). The chord length distribution (CLD) measured by the FBRM was used to represent granule particle size distribution (PSD). Through a systematic study, it was proved that the trends of the chord length measured by the at-line FBRM technique were identical to those measured by a laser diffraction instrument and sieve analysis in spite of different measurement mechanisms. The portable at-line FBRM technique was successfully applied to a granule growth kinetics study for a fluidized bed granulation performed in a Glatt GPCG-1 granulator. Granule size evolution was clearly exhibited by the at-line FBRM. Spray rate was found to be the most significant factor on the granule growth compared with the other two factors: binder solution concentration and intra- to extra-granular microcrystalline cellulose (MCC) ratio for the formulation studied in this work. The CLD evolution measured by the FBRM confirmed that the granule agglomeration was mainly dominated by the binder on the aranule surface. The at-line FBRM enables us to select appropriate process parameters and effectively control the fluid bed granulation process. (C) 2007 Elsevier B.V. All rights reserved.
引用
收藏
页码:54 / 61
页数:8
相关论文
共 34 条
[11]   Nucleation regime map for liquid bound granules [J].
Hapgood, KP ;
Litster, JD ;
Smith, R .
AICHE JOURNAL, 2003, 49 (02) :350-361
[12]  
Heath AR, 2002, PART PART SYST CHAR, V19, P84, DOI 10.1002/1521-4117(200205)19:2<84::AID-PPSC84>3.0.CO
[13]  
2-1
[14]  
Hemati A, 2003, POWDER TECHNOL, V130, P18
[15]  
JUSTIN L, 1996, STP PHARM, V6, P328
[16]   Use of focused beam reflectance measurement (FBRM) and process video imaging (PVI) in a modified mixed suspension mixed product removal (MSMPR) cooling crystallizer [J].
Kougoulos, E ;
Jones, AG ;
Jennings, KH ;
Wood-Kaczmar, MW .
JOURNAL OF CRYSTAL GROWTH, 2005, 273 (3-4) :529-534
[17]  
LAITINEN N, 2003, AAPS PHARMSCITECH, V4, P383, DOI DOI 10.1208/PT040449
[18]   CHARACTERIZATION OF WET GRANULATION PROCESS PARAMETERS USING RESPONSE-SURFACE METHODOLOGY .1. TOP-SPRAY FLUIDIZED-BED [J].
LIPPS, DM ;
SAKR, AM .
JOURNAL OF PHARMACEUTICAL SCIENCES, 1994, 83 (07) :937-947
[19]   Scaleup of wet granulation processes: science not art [J].
Litster, JD .
POWDER TECHNOLOGY, 2003, 130 (1-3) :35-40
[20]  
LIU CH, 1994, DRUG DEV IND PHARM, V20, P1911