Purpose: To predict the crystallization time of amorphous solid dispersions by controlling the combined effect of temperature and moisture content.
Methods: The authors exposed amorphous samples of spray-dried API and Hydroxypropylmethylcellulose Phtalate to various temperature and humidity conditions below and above the glass transition temperature (Tg) until crystallization of the API was observed. The crystallization of API was detected by XRPD, while the T ( g ) and the water absorption by the amorphous dispersion are quantified by mDSC and water sorption analysis.