Tambe Srushti, Jain Divya, Meruva Sai Kishore, Rongala Gopinath, Juluri Abhishek, Nihalani Girish, Mamidi Hemanth Kumar, Nukala Pavan Kumar, Bolla Pradeep Kumar
Department of Pharmaceutical Science and Technology, Institute of Chemical Technology, Mumbai 400019, India.
College of Pharmacy, University of Iowa, Iowa City, IA 52242, USA.
Pharmaceutics. 2022 Oct 16;14(10):2203. doi: 10.3390/pharmaceutics14102203.
Amorphous solid dispersions (ASDs) are among the most popular and widely studied solubility enhancement techniques. Since their inception in the early 1960s, the formulation development of ASDs has undergone tremendous progress. For instance, the method of preparing ASDs evolved from solvent-based approaches to solvent-free methods such as hot melt extrusion and Kinetisol. The formulation approaches have advanced from employing a single polymeric carrier to multiple carriers with plasticizers to improve the stability and performance of ASDs. Major excipient manufacturers recognized the potential of ASDs and began introducing specialty excipients ideal for formulating ASDs. In addition to traditional techniques such as differential scanning calorimeter (DSC) and X-ray crystallography, recent innovations such as nano-tomography, transmission electron microscopy (TEM), atomic force microscopy (AFM), and X-ray microscopy support a better understanding of the microstructure of ASDs. The purpose of this review is to highlight the recent advancements in the field of ASDs with respect to formulation approaches, methods of preparation, and advanced characterization techniques.
无定形固体分散体（ASDs）是最受欢迎且研究最广泛的溶解度增强技术之一。自20世纪60年代初问世以来，ASDs的制剂开发取得了巨大进展。例如，制备ASDs的方法从基于溶剂的方法发展到无溶剂方法，如热熔挤出和Kinetisol。制剂方法也从使用单一聚合物载体发展到使用多种带有增塑剂的载体，以提高ASDs的稳定性和性能。主要辅料制造商认识到ASDs的潜力，并开始推出适合配制ASDs的特种辅料。除了差示扫描量热法（DSC）和X射线晶体学等传统技术外，诸如纳米断层扫描、透射电子显微镜（TEM）、原子力显微镜（AFM）和X射线显微镜等最新创新技术有助于更好地理解ASDs的微观结构。本综述的目的是突出ASDs领域在制剂方法、制备方法和先进表征技术方面的最新进展。
