A systematic and robust assessment of hot-melt extrusion-based amorphous solid dispersions: Theoretical prediction to practical implementation

[Display omitted] Amorphous solid dispersions (ASDs) have gained attention as a formulation strategy in recent years, with the potential to improve the apparent solubility and, hence, the oral bioavailability of poorly soluble drugs. The process of formulating ASDs is commonly faced with challenges...

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Bibliographic Details
Published in:International journal of pharmaceutics 2022-08, Vol.624, p.121951-121951, Article 121951
Main Authors: Alzahrani, Abdullah, Nyavanandi, Dinesh, Mandati, Preethi, Youssef, Ahmed Adel Ali, Narala, Sagar, Bandari, Suresh, Repka, Michael
Format: Article
Language:English
Subjects:
Amorphous solid dispersion
Drug-polymer miscibility
Flory-Huggins
Hansen solubility parameter
Hot-melt extrusion
Phase diagram
Thermal prediction
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Summary:[Display omitted] Amorphous solid dispersions (ASDs) have gained attention as a formulation strategy in recent years, with the potential to improve the apparent solubility and, hence, the oral bioavailability of poorly soluble drugs. The process of formulating ASDs is commonly faced with challenges owing to the intrinsic physical and chemical instability of the initial amorphous form and the long-term physical stability of drug formulations. Numerous research publications on hot-melt extrusion (HME) technology have demonstrated that it is the most efficient approach for manufacturing reasonably stable ASDs. The HME technique has been established as a faster scale-up production strategy for formulation evaluation and has the potential to minimize the time to market. Thermodynamic evaluation and theoretical predictions of drug-polymer solubility and miscibility may assist to reduce the product development cost by HME. This review article highlights robust and established prediction theories and experimental approaches for the selection of polymeric carriers for the development of hot melt extrusion based stable amorphous solid dispersions (ASDs). In addition, this review makes a significant contribution to the literature as a pilot guide for ASD assessment, as well as to confirm the drug-polymer compatibility and physical stability of HME-based formulations.
ISSN:0378-5173
1873-3476
DOI:10.1016/j.ijpharm.2022.121951