热熔共挤技术作为抗高血压固定剂量联合用药的生产平台

Gareth C. Gilvary, A. Almajaan, Shu Li, Zoe Senta Loys, Yiwei Tian, Jeremiah Kelleher, A. Madi, A. Healy, David S. Jones, G. Andrews
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引用次数: 2

摘要

本工作的重点是通过先进的制造技术,热熔共挤出,同心多层固定剂量组合的发展。剂型设计提供不同的释放行为;分别从外壳和核心立即和持续释放。联合使用氢氯噻嗪和氯沙坦钾作为降压药。固态表征表明,两者都转化为无定形。体外溶出度测试显示出良好的释放性能,具有立即释放和缓释的双重效果。
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Hot-melt co-extrusion technology as a manufacturing platform for anti-hypertensive fixed-dose combinations
This work focused on the development of a concentric multi-layered fixed-dose combination via an advanced manufacturing technique, hot-melt co-extrusion. The dosage form was designed to offer differing release behaviour; immediate and sustained release from the coat and core, respectively. Hydrochlorothiazide and losartan potassium were incorporated as anti-hypertensive drugs. Solid-state characterisation revealed that both were transformed into their amorphous forms. In-vitro dissolution testing showed desired release performances offering both immediate and modified release.
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