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3D打印在口服药物递送中的应用:精准医学中的技术、临床应用及未来展望

3D Printing in Oral Drug Delivery: Technologies, Clinical Applications and Future Perspectives in Precision Medicine.

作者信息

Saleh-Bey-Kinj Zeena, Heller Yael, Socratous Giannis, Christodoulou Panayiota

机构信息

School of Medicine, European University Cyprus, 2404 Nicosia, Cyprus.

出版信息

Pharmaceuticals (Basel). 2025 Jun 28;18(7):973. doi: 10.3390/ph18070973.

Abstract

The recent advancement of 3D-printed drugs is an emerging technology that has the potential for effective and safe oral delivery of personalized treatment regimens to patients, replacing the current "one size fits all" philosophy. The objective of this literature review is to highlight the importance of 3D-printing technology in the development of personalized treatments, focusing on Levetiracetam, the first FDA-approved 3D-printed drug, for the treatment of epilepsy. Levetiracetam serves as an ideal paradigm for exploring how precision medicine and 3D printing can be applied to improve treatment outcomes for other complex diseases such as diabetes, cardiovascular diseases, and cancer. 3D printing enables precise dosage and time-release profiles by modifying factors such as shape and size, and the combination of active pharmaceutical ingredients (APIs) and excipients, ensuring consistent therapeutic levels over the treatment period. Design of oral tablets with multiple compartments allows for simultaneous treatment with multiple APIs, each one with a different release profile, minimizing drug-drug interactions and side effects. This technology also supports on-demand production, making it particularly beneficial in resource-limited or urgent situations, and offers the flexibility to customize dosage forms. Additive manufacturing could be an important tool for developing personalized treatments to address the diverse medical needs of patients with complex diseases. Therefore, there is a need for more 3D-printed FDA-approved drugs in the biopharmaceutical industry to enable personalized treatment, improved patient compliance, and precise drug release control.

摘要

3D打印药物的最新进展是一项新兴技术,有潜力向患者有效且安全地口服递送个性化治疗方案,取代当前“一刀切”的理念。这篇文献综述的目的是强调3D打印技术在个性化治疗开发中的重要性,重点关注左乙拉西坦,这是首个获美国食品药品监督管理局(FDA)批准的3D打印药物,用于治疗癫痫。左乙拉西坦是探索精准医学和3D打印如何应用于改善糖尿病、心血管疾病和癌症等其他复杂疾病治疗效果的理想范例。3D打印通过改变形状、尺寸等因素以及活性药物成分(API)与辅料的组合,实现精确的剂量和控释曲线,确保在治疗期间维持一致的治疗水平。具有多个隔室的口服片剂设计允许同时使用多种API进行治疗,每种API具有不同的释放曲线,从而将药物相互作用和副作用降至最低。这项技术还支持按需生产,在资源有限或紧急情况下尤其有益,并提供定制剂型的灵活性。增材制造可能是开发个性化治疗以满足复杂疾病患者多样化医疗需求的重要工具。因此,生物制药行业需要更多获FDA批准的3D打印药物,以实现个性化治疗、提高患者依从性并精确控制药物释放。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/08a4/12299587/eb010473fedc/pharmaceuticals-18-00973-g001.jpg

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