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现成药物的变革:通过半固体挤出增材制造定制剂量的酒石酸美托洛尔片以及在医院环境中对该技术的认知。

Off-the-shelf medication transformed: Custom-dosed metoprolol tartrate tablets via semisolid extrusion additive manufacturing and the perception of this technique in a hospital context.

作者信息

Levine Valerie R, Paulsson Mattias, Strømme Maria, Quodbach Julian, Lindh Jonas

机构信息

Division of Nanotechnology and Functional Materials, Department of Material Science and Engineering, Uppsala University, Uppsala SE-751 03, Box 35, Sweden.

Department of Women's and Children's Health, Uppsala University, SE-751 05 Uppsala, Box 256, Sweden.

出版信息

Int J Pharm X. 2024 Aug 17;8:100277. doi: 10.1016/j.ijpx.2024.100277. eCollection 2024 Dec.

DOI:10.1016/j.ijpx.2024.100277
PMID:39263003
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11388020/
Abstract

Pharmacies are currently unable to stock proper oral dosage forms for pediatric populations. This leads to manipulation of medications or the need to compound specialized medications, which can be a time-consuming process. Using Semisolid Extrusion (SSE) additive manufacturing (AM), specialized medications can be produced in an expedited process from off-the shelf medication in a hospital or outpatient pharmacy setting. In this study, tablets with a desired dose of 5 mg of metoprolol tartrate derived from commercial Seloken™ 50 mg tablets were 3D printed in a hospital setting. Validation testing was done on five batches, highlighting tablets with a high uniformity in mass and dimension, drug content, acceptable microbial assays, and prolonged release during in-vitro analysis. The average drug content found for the tablets was within ±6% of 5 mg for all batches produced. Comparisons were done between the SSE tablets and capsules produced in an external compounding facility, highlighting several positive aspects of SSE-produced tablets beyond simply shortening the production timeline. The SSE tablets printed in this study are characterized by their smaller size, enhanced prolonged release properties, and more uniform drug content across the tested samples. Additionally, interviews with pharmaceutical professionals were conducted to determine the positive aspects of SSE and further improvements to bring this technique as seamlessly as possible into the pharmacy. This study underscores the feasibility of employing SSE in the production of specialized medications within a hospital environment. Furthermore, it highlights the methodological advantages SSE offers over existing production standards, demonstrating its potential to improve pharmaceutical manufacturing in healthcare settings.

摘要

目前,药房无法储备适合儿科人群的口服剂型。这导致需要对药物进行调配或配制特殊药物,而这可能是一个耗时的过程。使用半固体挤出(SSE)增材制造(AM)技术,可以在医院或门诊药房环境中利用现成的药物,通过快速流程生产特殊药物。在本研究中,在医院环境中对由市售的倍他乐克50毫克片剂制得的、目标剂量为5毫克酒石酸美托洛尔的片剂进行了3D打印。对五批产品进行了验证测试,结果表明片剂在质量、尺寸、药物含量、可接受的微生物检测以及体外分析中的缓释性能方面具有高度均匀性。所生产的所有批次片剂的平均药物含量均在5毫克的±6%范围内。对SSE片剂与外部配制机构生产的胶囊进行了比较,突出了SSE生产的片剂除了单纯缩短生产时间线之外的几个积极方面。本研究中打印的SSE片剂的特点是尺寸更小、缓释性能增强,并且在测试样品中的药物含量更加均匀。此外,还对药学专业人员进行了访谈,以确定SSE的积极方面以及进一步改进措施,以便尽可能无缝地将该技术引入药房。本研究强调了在医院环境中采用SSE生产特殊药物的可行性。此外,它突出了SSE相对于现有生产标准所具有的方法学优势,证明了其在改善医疗保健环境中药物制造方面的潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e9c0/11388020/bc43b6439660/gr7.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e9c0/11388020/439411d22679/gr5.jpg
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