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使用自制直接粉末挤出打印机制造具有BCS II类分子速释功能的印刷片剂的可行性研究。

Feasibility study of the use of a homemade direct powder extrusion printer to manufacture printed tablets with an immediate release of a BCS II molecule.

作者信息

Jennotte O, Koch N, Lechanteur A, Rosoux F, Emmerechts C, Beeckman E, Evrard Brigitte

机构信息

Laboratory of Pharmaceutical Technology and Biopharmacy, Department of Pharmacy, Center for Interdisciplinary Research on Medicines (CIRM), University of Liege, 4000 Liege, Belgium.

Laboratory of Pharmaceutical Technology and Biopharmacy, Department of Pharmacy, Center for Interdisciplinary Research on Medicines (CIRM), University of Liege, 4000 Liege, Belgium.

出版信息

Int J Pharm. 2023 Nov 5;646:123506. doi: 10.1016/j.ijpharm.2023.123506. Epub 2023 Oct 11.

Abstract

Among the various 3D printing techniques, FDM is the most studied in pharmaceutical research. However, it requires the fabrication of filaments with suitable mechanical properties using HME, which can be laborious and time-consuming. DPE has emerged as a single-step printing technique that can overcome FDM limits as it enables the direct printing of powder blends without the need of filaments. This study demonstrated the manufacturing of cylindrical-shaped printed tablets containing CBD, a BCS II molecule, with an immediate release. Different blends of PEO/E100 and PEO/SOL, each with 10 % of CBD, were printed and tested according to the Eur. Ph. for uncoated tablets. Each printed cylinder met the Eur. Ph. specifications for friability, mass variation and mass uniformity. However, only the E100-based formulations enabled a CBD immediate release, as formulations containing SOL formed a gel once in contact with the dissolution medium, reducing the drug dissolution rate.

摘要

在各种3D打印技术中,熔融沉积成型(FDM)在药物研究中研究得最多。然而,它需要使用热熔挤出(HME)制造具有合适机械性能的长丝,这可能既费力又耗时。直接粉末挤出(DPE)已成为一种单步打印技术,它可以克服FDM的局限性,因为它能够直接打印粉末混合物,而无需长丝。本研究展示了含BCS II类分子大麻二酚(CBD)的速释圆柱形打印片剂的制造。按照欧洲药典对未包衣片剂的要求,打印并测试了含10% CBD的不同聚环氧乙烷/乙基纤维素(PEO/E100)和聚环氧乙烷/聚乙烯醇(PEO/SOL)混合物。每个打印圆柱体均符合欧洲药典关于脆碎度、质量变化和质量均匀性的规格要求。然而,只有基于E100的配方能够实现CBD速释,因为含SOL的配方一旦与溶出介质接触就会形成凝胶,降低药物溶出速率。

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