期刊
AAPS PHARMSCITECH
卷 22, 期 5, 页码 -出版社
SPRINGER
DOI: 10.1208/s12249-021-02017-7
关键词
hot-melt extrusion; amorphous solid dispersions; solubility enhancement; polymers; quality by design
资金
- Bluepharma, Coimbra, Portugal
- Fundacao para a Ciencia e Tecnologia (FCT), Portugal [PD/BDE/135149/2017]
- Fundação para a Ciência e a Tecnologia [PD/BDE/135149/2017] Funding Source: FCT
Hot-melt extrusion technology is widely used in pharmaceutical formulations to prepare solid dispersions for enhancing drug solubility. By applying the Quality by Design philosophy and process analytical technologies, the quality and process of hot-melt extrusion can be effectively monitored and controlled.
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.
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