逐层生产药品的新方法:增材制造

Lakshmi Usha Ayalasomayajula, Kishore Pathivada, Radha Rani Earle, A. Bhavani
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摘要

摘要:3D打印是一种从数字设计中逐层生产药物的新方法。它被认为是一种颠覆性的技术,有可能使传统制药产品的制造发生范式转变,这涉及到各种单元操作,如碾磨、混合、造粒、干燥和压缩。它导致最终产品的质量不同。药物的载药量、药物的释放度、药物的稳定性和药物剂型的稳定性影响产品的质量。美国食品和药物管理局批准3D打印药物正在创造一个制药制造的新时代。为了克服与传统制药设备操作相关的一些挑战,3D打印在未来的制药制造中越来越受到关注。3D打印能够克服多肽、强效药物、水溶性药物的药物递送和多种药物的释放等困难。另一方面,我们可以根据患者的需求准备患者特定或量身定制的药物,从而使药物安全管理,没有任何副作用或药物不良反应。然而,在监管方面存在一定的限制,阻碍了3d打印产品进入市场。©2020全球研究与出版基金会。
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Novel Approach for Producing Pharmaceuticals in Layer by Layer Fashion: Additive Manufacturing
drug three ABSTRACT: A novel approach for producing pharmaceuticals from digital designs, in a layer-by-layer fashion is 3D printing. It has been acclaimed as a disruptive technology having the potential to make a paradigm shift in the conventional manufacturing of pharmaceuticals products which involves various unit operations like milling, mixing, granulation, drying and compression. It results in final products of different qualities. The quality of the product is influenced by loading of the drug, release of the drug, stability of the drug and stability of pharmaceutical dosage form. FDA approved 3D printed drug is creating a novel era in pharmaceutical manufacturing. To overcome some of the challenges associated with conventional pharmaceutical unit operations, 3D printing is gaining more attention in the manufacture of pharmaceuticals in the future. 3D printing is capable of overcoming the difficulties relating to the drug delivery of peptides, potent drugs, water-soluble drugs, and the release of multi-drugs. On the other hand we can prepare patient specific or patient tailored medications on patient demand thus making safe administration of drug without any side effects or adverse drug effects. Nevertheless,certain limitations are there in terms of regulatory aspects hindering the launch of 3DP products into the market. © 2020 iGlobal Research and Publishing Foundation.
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