Pharmaceutics Research Laboratory, School of Life Sciences, University of Sussex, Brighton BN1 9QJ, UK.
Pharmaceutics Research Laboratory, School of Life Sciences, University of Sussex, Brighton BN1 9QJ, UK.
Int J Pharm. 2021 Mar 1;596:120237. doi: 10.1016/j.ijpharm.2021.120237. Epub 2021 Jan 21.
Oral dosage formulations are considered to be the most convenient pharmaceutical dosage forms for almost all ages because of their simplicity and non-invasive administration compared to other dosage forms. To improve therapeutic efficacy and avoid frequent daily doses, extending drug release profile is of great interest in pharmaceutical industry. Hot-Melt Extrusion (HME) has gained great attention in pharmaceutical industry since it is one of the continuous manufacturing processes, which can cut down production steps and human errors as opposed to batch to batch process. This controlled and continuous process can improve product quality and reproducibility. HME is a versatile technology, where controlled/sustained oral dosage forms have been one of its important production lines. With the emergence of 3D printing, the future of personalized medicine has become more applicable. Recently, there is a great orientation towards the combination of HME and Fused Deposition Modelling (FDM), in an aim to be a continuous process for personalized and telemedicine. Several extended-release formulations have been manufactured successfully through HME coupled with FDM. This review will shed light on pharmaceutical approaches used to control and sustain drug release in oral formulations by HME and its combination with FDM 3D printing. Quality by design approaches and critical process- and formulation-related factors that affect the release profiles in both HME and FDM will be also discussed clearly in this review.
口服剂型被认为是最方便的药物剂型，几乎适用于所有年龄段，因为与其他剂型相比，它具有简单、非侵入性的给药方式。为了提高治疗效果并避免频繁的每日剂量，延长药物释放曲线成为制药行业的一大关注点。热熔挤出（HME）在制药行业中受到了极大的关注，因为它是连续制造工艺之一，可以减少生产步骤和人为错误，而不是批处理过程。这种可控的连续工艺可以提高产品质量和重现性。HME 是一种多功能技术，其中控释/持续口服剂型是其重要的生产线之一。随着 3D 打印的出现，个性化医疗的未来变得更加适用。最近，人们非常关注 HME 和熔丝制造（FDM）的结合，旨在为个性化医疗和远程医疗提供一种连续的工艺。已经成功地通过 HME 结合 FDM 制造了几种控释制剂。本文综述了通过 HME 控制和维持口服制剂中药物释放的制药方法及其与 FDM 3D 打印的结合。本文还将清楚地讨论设计质量方法以及影响 HME 和 FDM 中释放曲线的关键工艺和配方相关因素。
