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热熔挤出技术在掩味中的应用

Hot Melt Extrusion Technology in Taste Masking.

作者信息

Nayak Geetha, Nayak Usha Y

机构信息

Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, 576104, Karnataka, India.

出版信息

AAPS PharmSciTech. 2025 Jul 22;26(7):196. doi: 10.1208/s12249-025-03174-9.

Abstract

Hot melt extrusion (HME) is a widely used method of taste masking in medication formulations, notably for bitter Active Pharmaceutical Ingredients (APIs). This continuous, solvent-free technique successfully wraps APIs within a polymer matrix, forming a barrier that considerably decreases bitterness perception. These advantageous properties of HME in taste masking are especially important for pediatric, geriatric, and veterinary formulations, where palatability is critical. The technique entails melting a polymer matrix and combining it with the medicine, followed by extrusion to make granules or dosage forms. The efficacy of taste masking is dependent on selecting acceptable excipients and ensuring their compatibility with the medicine. Temperature, screw speed, and drug-to-polymer ratio are critical process parameters that must be tuned. Various screw configurations can influence the physical condition of the API during extrusion, increasing taste-masking efficacy. Future advances in HME technology are expected, with a focus on enhancing taste masking for a broader range of APIs. Innovations in the study of polymers and the combination of process analytical technology (PAT) will significantly enhance the effectiveness and reliability of flavor-masked formulations, resolving the important need for patient-friendly drugs that are taken orally.

摘要

热熔挤出(HME)是药物制剂中广泛使用的一种掩味方法,尤其适用于苦味活性药物成分(API)。这种连续的、无溶剂技术成功地将API包裹在聚合物基质中,形成一道屏障,大大降低了苦味感知。HME在掩味方面的这些有利特性对于儿科、老年科和兽用制剂尤为重要,因为适口性至关重要。该技术需要将聚合物基质熔化并与药物混合,然后挤出制成颗粒或剂型。掩味效果取决于选择合适的辅料并确保它们与药物的相容性。温度、螺杆速度和药物与聚合物的比例是必须调整的关键工艺参数。各种螺杆配置会影响挤出过程中API的物理状态,提高掩味效果。预计HME技术未来会取得进展,重点是增强对更广泛API的掩味效果。聚合物研究方面的创新以及过程分析技术(PAT)的结合将显著提高掩味制剂的有效性和可靠性,满足对口服的患者友好型药物的重要需求。

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