改变现成药物:通过半固态挤压快速成型技术定制酒石酸美托洛尔片剂以及医院对该技术的认识

IF 5.2 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Valerie R. Levine , Mattias Paulsson , Maria Strømme , Julian Quodbach , Jonas Lindh
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引用次数: 0

摘要

目前,药房无法为儿童储备适当的口服剂型。这就导致了药物的篡改或需要配制专用药物,而这可能是一个耗时的过程。利用半固态挤压(SSE)添加剂制造(AM)技术,可以在医院或门诊药房环境中以现成药物为原料快速生产出专用药物。在这项研究中,在医院环境中对来自商用 Seloken™ 50 毫克片剂的 5 毫克酒石酸美托洛尔片剂进行了 3D 打印。对五个批次的药片进行了验证测试,结果表明,这些药片在质量和尺寸、药物含量、可接受的微生物检测以及体外分析中的延长释放等方面具有高度的一致性。所有批次药片的平均药物含量均在 5 毫克的 ±6% 范围内。在 SSE 片剂和外部复合工厂生产的胶囊之间进行了比较,突出了 SSE 生产片剂的几个积极方面,而不仅仅是缩短了生产时间。本研究中印制的 SSE 片剂的特点是尺寸更小、缓释性能更强、测试样品的药物含量更均匀。此外,研究人员还对制药专业人士进行了采访,以确定 SSE 的积极方面以及进一步的改进措施,从而使这项技术尽可能无缝地进入药房。这项研究强调了在医院环境中使用 SSE 生产特殊药物的可行性。此外,它还强调了 SSE 与现有生产标准相比所具有的方法优势,展示了其改善医疗机构药品生产的潜力。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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

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

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.

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来源期刊
International Journal of Pharmaceutics: X
International Journal of Pharmaceutics: X Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
6.60
自引率
0.00%
发文量
32
审稿时长
24 days
期刊介绍: International Journal of Pharmaceutics: X offers authors with high-quality research who want to publish in a gold open access journal the opportunity to make their work immediately, permanently, and freely accessible. International Journal of Pharmaceutics: X authors will pay an article publishing charge (APC), have a choice of license options, and retain copyright. Please check the APC here. The journal is indexed in SCOPUS, PUBMED, PMC and DOAJ. The International Journal of Pharmaceutics is the second most cited journal in the "Pharmacy & Pharmacology" category out of 358 journals, being the true home for pharmaceutical scientists concerned with the physical, chemical and biological properties of devices and delivery systems for drugs, vaccines and biologicals, including their design, manufacture and evaluation. This includes evaluation of the properties of drugs, excipients such as surfactants and polymers and novel materials. The journal has special sections on pharmaceutical nanotechnology and personalized medicines, and publishes research papers, reviews, commentaries and letters to the editor as well as special issues.
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