Process analytical technology based quality assurance of API concentration and fiber diameter of electrospun amorphous solid dispersions

IF 4.4 2区 医学 Q1 PHARMACOLOGY & PHARMACY European Journal of Pharmaceutics and Biopharmaceutics Pub Date : 2024-10-09 DOI:10.1016/j.ejpb.2024.114529
Bettina Fazekas, Orsolya Péterfi, Dorián László Galata, Zsombor Kristóf Nagy, Edit Hirsch
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Abstract

In this study, a novel quality assurance system was developed utilizing Process analytical technology (PAT) tools and artificial intelligence (AI). Our goal was to monitor the critical quality attributes (CQAs) like drug concentration, morphology and fiber diameter of electrospun amorphous solid dispersion (ASD) formulations with fast at-line techniques. Doxycycline-hyclate (DOX), a tetracycline-type antibiotic was used as a model drug with 2-hydroxypropyl-β-cyclodextrin (HP-β-CD) as the matrix excipient. The water-based formulations were electrospun with high-speed electrospinning (HSES). Raman and NIR sensors and machine vision-based color measurement techniques were employed to accurately determine the drug concentration. Given that morphology can influence the solubility of the drug, a convolutional neural network (CNN)-based AI model was developed to examine this property and detect manufacturing defects. Additionally, the diameter of electrospun fibrous samples was measured using camera images and a trained AI model, enabling rapid analysis of fiber diameter with results similar to that of scanning electron microscopy (SEM). These methods and models demonstrate potential in-line analytical tools, offering rapid, cheap and non-destructive analysis of ASD formulations.

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基于过程分析技术的电纺无定形固体分散体原料药浓度和纤维直径质量保证。
本研究利用过程分析技术(PAT)工具和人工智能(AI)开发了一种新型质量保证系统。我们的目标是利用快速在线技术监测电纺无定形固体分散体(ASD)制剂的药物浓度、形态和纤维直径等关键质量属性(CQAs)。以四环素类抗生素 DOX 为模型药物,2-羟丙基-β-环糊精(HP-β-CD)为基质赋形剂。水基制剂采用高速电纺丝(HSES)技术进行电纺丝。采用拉曼和近红外传感器以及基于机器视觉的颜色测量技术来准确测定药物浓度。鉴于形态会影响药物的溶解度,我们开发了一个基于卷积神经网络(CNN)的人工智能模型来检查这一特性并检测制造缺陷。此外,还利用相机图像和训练有素的人工智能模型测量了电纺纤维样品的直径,从而实现了纤维直径的快速分析,其结果与扫描电子显微镜(SEM)类似。这些方法和模型展示了潜在的在线分析工具,可对 ASD 配方进行快速、廉价和无损分析。
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来源期刊
CiteScore
8.80
自引率
4.10%
发文量
211
审稿时长
36 days
期刊介绍: The European Journal of Pharmaceutics and Biopharmaceutics provides a medium for the publication of novel, innovative and hypothesis-driven research from the areas of Pharmaceutics and Biopharmaceutics. Topics covered include for example: Design and development of drug delivery systems for pharmaceuticals and biopharmaceuticals (small molecules, proteins, nucleic acids) Aspects of manufacturing process design Biomedical aspects of drug product design Strategies and formulations for controlled drug transport across biological barriers Physicochemical aspects of drug product development Novel excipients for drug product design Drug delivery and controlled release systems for systemic and local applications Nanomaterials for therapeutic and diagnostic purposes Advanced therapy medicinal products Medical devices supporting a distinct pharmacological effect.
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