Hot-Melt Extrusion: a Roadmap for Product Development

Hot-melt extrusion has found extensive application as a feasible pharmaceutical technological option over recent years. HME applications include solubility enhancement, taste masking, and sustained drug release. As bioavailability enhancement is a hot topic of today’s science, one of the main applic...

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Bibliographic Details
Published inAAPS PharmSciTech Vol. 22; no. 5
Main Authors Simões, Marta F., Pinto, Rui M. A., Simões, Sérgio
Format Journal Article
LanguageEnglish
Published Cham Springer International Publishing 17.06.2021
Subjects
Biochemistry
Biomedical and Life Sciences
Biomedicine
Biotechnology
Pharmacology/Toxicology
Pharmacy
Review Article
quality by design
solubility enhancement
polymers
hot-melt extrusion
amorphous solid dispersions
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Summary:Hot-melt extrusion has found extensive application as a feasible pharmaceutical technological option over recent years. HME applications include solubility enhancement, taste masking, and sustained drug release. As bioavailability enhancement is a hot topic of today’s science, one of the main applications of HME is centered on amorphous solid dispersions. This review describes the most significant aspects of HME technology and its use to prepare solid dispersions as a drug formulation strategy to enhance the solubility of poorly soluble drugs. It also addresses molecular and thermodynamic features critical for the physicochemical properties of these systems, mainly in what concerns miscibility and physical stability. Moreover, the importance of applying the Quality by Design philosophy in drug development is also discussed, as well as process analytical technologies in pharmaceutical HME monitoring, under the current standards of product development and regulatory guidance. Graphical Abstract
ISSN:1530-9932
DOI:10.1208/s12249-021-02017-7