通过基于半固体挤压的3D打印个性化医疗:双重药物加载的软糖,以提高患者的依从性。

IF 3.5 3区 医学 Q2 CHEMISTRY, MULTIDISCIPLINARY Pharmaceutical Research Pub Date : 2025-01-01 Epub Date: 2025-01-17 DOI:10.1007/s11095-024-03813-z
Aditi Holkunde, Indrajeet Karnik, Prateek Uttreja, Nagarjuna Narala, Honghe Wang, Rasha M Elkanayati, Sateesh Kumar Vemula, Michael A Repka
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引用次数: 0

摘要

目的:本研究的目的是利用半固体挤出(SSE) 3D打印技术开发和表征双药异烟肼-吡哆醇胶粘剂,旨在为从儿童到老年人的广泛患者群体提供个性化剂量。这项研究利用SSE 3D打印,这是一种个性化医疗的创新方法,可以实现精确的剂量定制并提高患者的依从性。通过配制双重药物负载口香糖,该研究解决了与传统结核病方案相关的药丸负担和不良适口性的挑战,最终提高了不同年龄组患者的治疗体验和有效性。方法:使用不同比例的明胶、卡拉胶和木糖醇配制胶粘剂,并使用BIO X 3D打印机打印。流变特性进行了评估,以确认印刷性,剪切减薄行为和粘度恢复。在冷藏(5±3°C)和常温(25±2°C)条件下评估体外药物释放和稳定性。利用傅里叶变换红外光谱分析药物-赋形剂相互作用。结果:优化后的F3配方含有900 mg异烟肼和30 mg吡哆醇,具有良好的印刷性和结构完整性。超过80%的两种药物在30分钟内释放。流变学测试证实了挤出打印的理想剪切减薄和粘弹性性能。观察到适合儿科患者依从性的纹理特性。稳定性研究表明,药物含量和释放谱在冷藏储存30天内保持一致。结论:本研究确定了SSE 3D打印在制造个性化异烟肼-吡哆醇负载口香糖方面的潜力,为结核病治疗提供了一种新颖的、对患者友好的剂型。优化后的配方表现出优异的可打印性、稳定性和快速药物释放,将3d打印的软糖定位为传统口服剂型的有希望的替代品,可以提高患者的依从性。
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Personalized Medicine Through Semisolid-Extrusion Based 3D Printing: Dual-Drug Loaded Gummies for Enhanced Patient Compliance.

Purpose: The purpose of this research was to develop and characterize dual-drug Isoniazid-Pyridoxine gummies using Semisolid Extrusion (SSE) 3D printing technology, aimed at personalized dosing for a broad patient demographic, from pediatric to geriatric. This study leverages SSE 3D printing, an innovative approach in personalized medicine, to enable precise dose customization and improve patient adherence. By formulating dual drug-loaded gummies, the research addresses the challenges of pill burden and poor palatability associated with traditional tuberculosis regimens, ultimately enhancing the therapeutic experience and effectiveness for patients across various age groups.

Methods: Gummies were formulated using varying ratios of gelatin, carrageenan, and xylitol, and printed using the BIO X 3D printer. Rheological properties were evaluated to confirm printability, shear-thinning behavior, and viscosity recovery. In vitro drug release and stability were assessed under refrigerated (5 ± 3°C) and ambient (25 ± 2°C) storage conditions. FT-IR spectroscopy was used to examine drug-excipient interactions.

Results: The optimized F3 formulation, containing 900 mg Isoniazid and 30 mg Pyridoxine, demonstrated successful printability and structural integrity. Over 80% of both drugs were released within 30 min. Rheological testing confirmed ideal shear-thinning and viscoelastic properties for extrusion-based printing. Suitable textural properties for pediatric patient compliance were observed. Stability studies showed that both drug content and release profiles remained consistent for 30 days under refrigerated storage.

Conclusions: This study determines the potential of SSE 3D printing in fabricating personalized Isoniazid-Pyridoxine-loaded gummies, offering a novel, patient-friendly dosage form for tuberculosis treatment. The optimized formulation exhibited excellent printability, stability, and rapid drug release, positioning 3D-printed gummies as a promising alternative to conventional oral dosage forms in enhancing patient adherence.

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来源期刊
Pharmaceutical Research
Pharmaceutical Research 医学-化学综合
CiteScore
6.60
自引率
5.40%
发文量
276
审稿时长
3.4 months
期刊介绍: Pharmaceutical Research, an official journal of the American Association of Pharmaceutical Scientists, is committed to publishing novel research that is mechanism-based, hypothesis-driven and addresses significant issues in drug discovery, development and regulation. Current areas of interest include, but are not limited to: -(pre)formulation engineering and processing- computational biopharmaceutics- drug delivery and targeting- molecular biopharmaceutics and drug disposition (including cellular and molecular pharmacology)- pharmacokinetics, pharmacodynamics and pharmacogenetics. Research may involve nonclinical and clinical studies, and utilize both in vitro and in vivo approaches. Studies on small drug molecules, pharmaceutical solid materials (including biomaterials, polymers and nanoparticles) biotechnology products (including genes, peptides, proteins and vaccines), and genetically engineered cells are welcome.
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