Recent Advances in Amorphous Solid Dispersions: Preformulation, Formulation Strategies, Technological Advancements and Characterization

被引:60
作者
Tambe, Srushti [1 ]
Jain, Divya [1 ]
Meruva, Sai Kishore [2 ]
Rongala, Gopinath [3 ]
Juluri, Abhishek [4 ]
Nihalani, Girish [5 ]
Mamidi, Hemanth Kumar [6 ]
Nukala, Pavan Kumar [6 ]
Bolla, Pradeep Kumar [7 ]
机构
[1] Inst Chem Technol, Dept Pharmaceut Sci & Technol, Mumbai 400019, Maharashtra, India
[2] Univ Iowa, Coll Pharm, Iowa City, IA 52242 USA
[3] Venatorx Pharmaceut Inc, 74 E Swedesford Rd Suite 100, Malvern, PA 19355 USA
[4] Univ Mississippi, Dept Pharmaceut, Oxford, MS 38677 USA
[5] Teva Pharmaceut USA, Weston, FL 33331 USA
[6] St Johns Univ, Coll Pharm & Hlth Sci, Queens, NY 11439 USA
[7] Univ Texas El Paso, Coll Engn, Dept Biomed Engn, 500 W Univ Ave, El Paso, TX 79968 USA
关键词
amorphous solid dispersions; glass transition temperature; poorly soluble drugs; super saturation; recrystallization; surfactants; lipids; pill burden; spray drying; hot melt extrusion; Kinetisol (R); 3D printing; characterization; polymers; HOT-MELT EXTRUSION; STATE CHARACTERIZATION; CLASSIFICATION-SYSTEM; PROCESS OPTIMIZATION; POLYMER SOLUBILITY; PHYSICAL STABILITY; THERMAL-ANALYSIS; PHASE-BEHAVIOR; DISSOLUTION; CRYSTALLIZATION;
D O I
10.3390/pharmaceutics14102203
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
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 (R). 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
引用
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页数:33
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