Saker Ranim, Regdon Géza, Ludasi Krisztina, Sovány Tamás
Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös u 6, H-6720 Szeged, Hungary.
Pharmaceutics. 2025 Jan 1;17(1):47. doi: 10.3390/pharmaceutics17010047.
Nanotechnology has been the main area of focus for research in different disciplines, such as medicine, engineering, and applied sciences. Therefore, enormous efforts have been made to insert the use of nanoparticles into the daily routines of different platforms due to their impressive performance and the huge potential they could offer. Among numerous types of nanomaterials, titanate nanotubes have been widely recognised as some of the most promising nanocarriers due to their outstanding profile and brilliant design. Their implementation in pharmaceutical applications is of huge interest nowadays as it could be of fundamental importance in the development of the pharmaceutical industry and therapeutic systems.
In the present work, a risk assessment-based procedure was developed and completed using ANN-based modeling to enable the design and fabrication of titanate nanotube-based drug delivery systems with desired properties, based on the critical analysis and evaluation of data collected from published articles regarding titanate nanotube preparation using the hydrothermal treatment method.
This analysis is presented as an integrated pathway for titanate nanotube preparation and utilization in a proper way that meets the strict requirements of pharmaceutical systems (quality, safety, and efficacy). Furthermore, a reasonable estimation of the factors affecting titanate nanotube preparation and transformation from traditional uses to novel pharmaceutical ones was established with the aid of a quality by design approach and risk assessment tools, mainly an Ishikawa diagram, a risk estimation matrix, and Pareto analysis.
To the best of our knowledge, this is the first article using the QbD approach to suggest a systematic method for the purpose of upgrading TNT use to the pharmaceutical domain.
纳米技术一直是医学、工程学和应用科学等不同学科研究的主要焦点领域。因此，由于纳米颗粒令人印象深刻的性能及其巨大潜力，人们已做出巨大努力将其应用融入不同平台的日常应用中。在众多类型的纳米材料中，钛酸盐纳米管因其出色的特性和卓越的设计而被广泛认为是最有前景的纳米载体之一。如今，它们在药物应用中的应用备受关注，因为这可能对制药行业和治疗系统的发展至关重要。
在本研究中，基于对已发表文章中有关水热法制备钛酸盐纳米管所收集数据的批判性分析和评估，开发并完成了一种基于风险评估的程序，该程序使用基于人工神经网络的建模来设计和制造具有所需特性的基于钛酸盐纳米管的药物递送系统。
该分析呈现为一种以适当方式制备和利用钛酸盐纳米管的综合途径，以满足制药系统的严格要求（质量、安全性和有效性）。此外，借助质量源于设计方法和风险评估工具，主要是石川图、风险估计矩阵和帕累托分析，对影响钛酸盐纳米管制备以及从传统用途向新型药物用途转变的因素进行了合理估计。
据我们所知，这是第一篇使用质量源于设计方法提出将钛酸盐纳米管升级应用于制药领域的系统方法的文章。
