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Published on: August 9, 2022
Physical stability of amorphous pharmaceutical solids: Nucleation, crystal growth, phase separation and effects of
Qin Shi1, Fang Li2, Stacy Yeh3
1School of Pharmacy, Jiangsu Vocational College of Medicine, Yancheng 224005, China; Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University, Nanjing 210009, China.
Abstract:
Compared to their crystalline forms, amorphous pharmaceutical solids present marvelous potential and advantages for effectively improving the oral bioavailability of poorly water-soluble drugs. A central issue in developing amorphous pharmaceutical solids is the stability against crystallization, which is particularly important for maintaining their advantages in solubility and dissolution rate. This review provides a comprehensive overview of recent studies focusing on the physical stability of amorphous pharmaceutical solids affected by nucleation, crystal growth, phase separation and the addition of polymers. Moreover, we highlight the novel technologies and theories in the field of amorphous pharmaceutical solids. Meanwhile, the challenges and strategies in maintaining the physical stability of amorphous pharmaceutical solids are also discussed. With a better understanding of physical stability, the more robust amorphous pharmaceutical formulations with desired pharmaceutical performance would be easier to achieve.
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