药物3D打印:从实验规模到商业开发的方法

IF 3.4 Q2 PHARMACOLOGY & PHARMACY Future Journal of Pharmaceutical Sciences Pub Date : 2022-11-26 DOI:10.1186/s43094-022-00439-z
Ranjitsinh Pawar, Atmaram Pawar
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引用次数: 2

摘要

三维(3D)打印是医疗保健领域的范式转变。3D打印是一种平台技术,可以使用较少的添加剂开发复杂的产品。简单的开发过程使其优于传统方法。每个人都需要特定剂量的治疗。“一刀切”是目前的传统方法,在3D打印中可以转变为更个性化的方法。本综述旨在涵盖3D打印的药物选择、聚合物和技术方面的不同观点。在临床实践方面,本文还讨论了监管问题和工业潜力。在不久的将来,以患者为中心的个体化用药将成为现实。它通过考虑遗传谱、生理和疾病状况来提供个体所需的剂量。具有不同几何形状和大小的独特载药和释药轮廓的定制剂量可以方便地递送治疗剂量。该技术既能满足儿科、老年等以患者为导向的行业对剂量准确性的效率要求,又易于符合规范市场的cGMP要求。临床实践可侧重于处方每个人的剂量的必要性。2015年,美国FDA批准了首个3D打印药品,这是药品生产新阶段的开端。量身定制的配方可以在未来的个性化药物。获得监管机构的批准后,3d打印产品才能进入市场。未来,配方师可以通过3d打印医药产品带来不同行业的个性化需求产品。图形抽象
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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3D printing of pharmaceuticals: approach from bench scale to commercial development

Background

The three-dimensional (3D) printing is paradigm shift in the healthcare sector. 3D printing is platform technologies in which complex products are developed with less number of additives. The easy development process gives edge over the conventional methods. Every individual needs specific dose treatment. ‘One size fits all’ is the current traditional approach that can shift to more individual specific in 3D printing. The present review aims to cover different perspectives regarding selection of drug, polymer and technological aspects for 3D printing. With respect to clinical practice, regulatory issue and industrial potential are also discussed in this paper.

Main body

The individualization of medicines with patient centric dosage form will become reality in upcoming future. It provides individual’s need of dose by considering genetic profile, physiology and diseased condition. The tailormade dosages with unique drug loading and release profile of different geometrical shapes and sizes can easily deliver therapeutic dose. The technology can fulfill growing demand of efficiency in the dose accuracy for the patient oriented sectors like pediatric, geriatric and also easy to comply with cGMP requirements of regulated market. The clinical practice can focus on prescribing each individual’s necessity of dose.

Conclusion

In the year 2015, FDA approved first 3D printed drug product, which is initiator in the new phase of manufacturing of pharmaceuticals. The tailormade formulations can be made in future for personalized medications. Regulatory approval from agencies can bring the 3DP product into the market. In the future, formulators can bring different sector-specific products for personalized need through 3DP pharmaceutical product.

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来源期刊
自引率
0.00%
发文量
44
审稿时长
23 weeks
期刊介绍: Future Journal of Pharmaceutical Sciences (FJPS) is the official journal of the Future University in Egypt. It is a peer-reviewed, open access journal which publishes original research articles, review articles and case studies on all aspects of pharmaceutical sciences and technologies, pharmacy practice and related clinical aspects, and pharmacy education. The journal publishes articles covering developments in drug absorption and metabolism, pharmacokinetics and dynamics, drug delivery systems, drug targeting and nano-technology. It also covers development of new systems, methods and techniques in pharmacy education and practice. The scope of the journal also extends to cover advancements in toxicology, cell and molecular biology, biomedical research, clinical and pharmaceutical microbiology, pharmaceutical biotechnology, medicinal chemistry, phytochemistry and nutraceuticals.
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