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Volume 14
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Review

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

by
Srushti Tambe
1,†,
Divya Jain
1,†,
Sai Kishore Meruva
2,
Gopinath Rongala
3,
Abhishek Juluri
4,
Girish Nihalani
5,
Hemanth Kumar Mamidi
6,*,
Pavan Kumar Nukala
6,* and
Pradeep Kumar Bolla
7,*
1
Department of Pharmaceutical Science and Technology, Institute of Chemical Technology, Mumbai 400019, India
2
College of Pharmacy, University of Iowa, Iowa City, IA 52242, USA
3
Venatorx Pharmaceuticals, Inc., 74 E Swedesford Rd. Suite 100, Malvern, PA 19355, USA
4
Department of Pharmaceutics, The University of Mississippi, Oxford, MS 38677, USA
5
Teva Pharmaceuticals USA, Weston, FL 33331, USA
6
College of Pharmacy and Health Sciences, St. John’s University, Queens, NY 11439, USA
7
Department of Biomedical Engineering, College of Engineering, The University of Texas at El Paso, 500 W. University Ave., El Paso, TX 79968, USA
*
Authors to whom correspondence should be addressed.
†
These authors contributed equally to this work.
Pharmaceutics 2022, 14(10), 2203; https://doi.org/10.3390/pharmaceutics14102203
Submission received: 9 August 2022 / Revised: 27 September 2022 / Accepted: 13 October 2022 / Published: 16 October 2022
(This article belongs to the Special Issue Advances in Amorphous Drug Formulations, Volume II)
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Abstract

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
Keywords: amorphous solid dispersions; glass transition temperature; poorly soluble drugs; super saturation; recrystallization; surfactants; lipids; pill burden; spray drying; hot melt extrusion; Kinetisol®; 3D printing; characterization; polymers amorphous solid dispersions; glass transition temperature; poorly soluble drugs; super saturation; recrystallization; surfactants; lipids; pill burden; spray drying; hot melt extrusion; Kinetisol®; 3D printing; characterization; polymers
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MDPI and ACS Style

Tambe, S.; Jain, D.; Meruva, S.K.; Rongala, G.; Juluri, A.; Nihalani, G.; Mamidi, H.K.; Nukala, P.K.; Bolla, P.K. Recent Advances in Amorphous Solid Dispersions: Preformulation, Formulation Strategies, Technological Advancements and Characterization. Pharmaceutics 2022, 14, 2203. https://doi.org/10.3390/pharmaceutics14102203

AMA Style

Tambe S, Jain D, Meruva SK, Rongala G, Juluri A, Nihalani G, Mamidi HK, Nukala PK, Bolla PK. Recent Advances in Amorphous Solid Dispersions: Preformulation, Formulation Strategies, Technological Advancements and Characterization. Pharmaceutics. 2022; 14(10):2203. https://doi.org/10.3390/pharmaceutics14102203

Chicago/Turabian Style

Tambe, Srushti, Divya Jain, Sai Kishore Meruva, Gopinath Rongala, Abhishek Juluri, Girish Nihalani, Hemanth Kumar Mamidi, Pavan Kumar Nukala, and Pradeep Kumar Bolla. 2022. "Recent Advances in Amorphous Solid Dispersions: Preformulation, Formulation Strategies, Technological Advancements and Characterization" Pharmaceutics 14, no. 10: 2203. https://doi.org/10.3390/pharmaceutics14102203

APA Style

Tambe, S., Jain, D., Meruva, S. K., Rongala, G., Juluri, A., Nihalani, G., Mamidi, H. K., Nukala, P. K., & Bolla, P. K. (2022). Recent Advances in Amorphous Solid Dispersions: Preformulation, Formulation Strategies, Technological Advancements and Characterization. Pharmaceutics, 14(10), 2203. https://doi.org/10.3390/pharmaceutics14102203

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