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使用选择性激光烧结技术制造 3D 打印口腔崩解打印片。

Fabricating 3D printed orally disintegrating printlets using selective laser sintering.

机构信息

Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK.

FabRx Ltd., 3 Romney Road, Ashford, Kent TN24 0RW, UK.

出版信息

Int J Pharm. 2018 Apr 25;541(1-2):101-107. doi: 10.1016/j.ijpharm.2018.02.015. Epub 2018 Feb 14.

DOI:10.1016/j.ijpharm.2018.02.015
PMID:29454028
Abstract

Selective laser sintering (SLS) is a three-dimensional printing (3DP) technology employed to manufacture plastic, metallic or ceramic objects. The aim of this study was to demonstrate the feasibility of using SLS to fabricate novel solid dosage forms with accelerated drug release properties, and with a view to create orally disintegrating formulations. Two polymers (hydroxypropyl methylcellulose (HPMC E5) and vinylpyrrolidone-vinyl acetate copolymer (Kollidon VA 64)) were separately mixed with 5% paracetamol (used as a model drug) and 3% Candurin Gold Sheen colorant; the powder mixes were subjected to SLS printing, resulting in the manufacture of printlets (3DP tablets). Modulating the SLS printing parameters altered the release characteristics of the printlets, with faster laser scanning speeds accelerating drug release from the HPMC formulations. The same trend was observed for the Kollidon based printlets. At a laser scanning speed of 300 mm/s, the Kollidon printlets exhibited orally disintegrating characteristics by completely dispersing in <4 s in a small volume of water. X-ray micro-CT analysis of these printlets indicated a reduction in their density and an increase in open porosity, therefore, confirming the unique disintegration behaviour of these formulations. The work reported here is the first to demonstrate the feasibility of SLS 3DP to fabricate printlets with accelerated drug release and orally disintegrating properties. This investigation has confirmed that SLS is amenable to the pharmaceutical research of modern medicine manufacture.

摘要

选择性激光烧结(SLS)是一种三维打印(3DP)技术,用于制造塑料、金属或陶瓷物体。本研究的目的是展示使用 SLS 制造具有加速药物释放特性的新型固体制剂的可行性,并旨在创建可口服崩解的制剂。两种聚合物(羟丙基甲基纤维素(HPMC E5)和乙烯基吡咯烷酮-乙酸乙烯酯共聚物(Kollidon VA 64))分别与 5%对乙酰氨基酚(用作模型药物)和 3%坎迪林金光泽色料混合;将粉末混合物进行 SLS 打印,从而制造出印片(3DP 片剂)。调节 SLS 打印参数改变了印片的释放特性,更快的激光扫描速度加速了 HPMC 制剂的药物释放。基于 Kollidon 的印片也观察到了相同的趋势。在激光扫描速度为 300mm/s 时,Kollidon 印片在少量水中完全分散在<4s 内,具有可口服崩解的特性。这些印片的 X 射线微计算机断层扫描(micro-CT)分析表明,其密度降低,开放孔隙率增加,因此证实了这些制剂独特的崩解行为。这里报道的工作首次证明了 SLS 3DP 制造具有加速药物释放和可口服崩解特性的印片的可行性。这项研究证实,SLS 适用于现代医学制造的药物研究。

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