Investigating the moisture-induced crystallization kinetics of spray-dried lactose

被引:47
作者
Burnett, DJ
Thielmann, F
Sokoloski, T
Brum, J
机构
[1] Surface Measurement Syst Ltd, Allentown, PA 18103 USA
[2] Surface Measurement Syst Ltd, Alperton HA0 4PE, Middx, England
[3] GlaxoSmithKline, Collegeville, PA 19426 USA
关键词
vapor sorption; phase transition; humidity; amorphous; crystallization kinetics; spray-drying;
D O I
10.1016/j.ijpharm.2006.01.012
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Gravimetric water sorption experiments were performed to study the crystallization behavior of amorphous spray-dried lactose over a wide range of temperature and humidity conditions. Experiments performed at 25 degrees C between 48 and 60% relative humidity (RH) showed that the onset time to crystallization increased dramatically with decreasing humidity. At 55% RH and above, crystallization occurred in a single detectible step, while below a two-step process was observed. Experiments performed at 51% RH between 22 and 32 degrees C indicated the induction time to crystallization onset increased with decreasing temperature. Above 25 degrees C at 51% RH, crystallization occurred in one measurable step, while below crystallization occurred in two steps. The constant RH with varying temperature results were modeled to determine the crystallization mechanism. Above 25 degrees C a mechanism consisting of two competing reaction sequences fit the data with a 0.9997 correlation coefficient. Both reaction sequences have two steps: an auto-catalytic first step is followed by a three-dimensional diffusion controlled water loss step. (c) 2006 Elsevier B.V. All rights reserved.
引用
收藏
页码:23 / 28
页数:6
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