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Determining the critical relative humidity for moisture-induced phase transitions.
International Journal of Pharmaceutics 2004 December 10
A new method to determine the onset relative humidity for a glass transition and crystallization processes in amorphous or partially amorphous materials was developed using dynamic gravimetric vapor sorption (DVS). Water vapor can act as a plasticizing agent in amorphous materials, thus lowering the glass transition temperature below room temperatures. Additional water sorption can lead to a crystallization event below the glass transition temperature. On spray-dried lactose the glass transition RH and crystallization RH values were 30 and 58% at 25 degrees C, respectively. Glass transition and crystallization RH values were also measured at 5, 15, 25, 35, and 45 degrees C on a spray-dried salbutamol sulfate sample. The glass transition RH values for the salbutamol sulfate sample ranged from 64.5% RH (5 degrees C) to 32.8% RH (45 degrees C) while the crystallization RH values ranged from 81.0% RH (5 degrees C) to 50.4% RH (45 degrees C). The results clearly show that the glass transition and crystallization humidity values decrease as the sample temperature increases.
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