基于自动3D打印的医疗系统药房环境下儿科皮质类固醇剂型非无菌配药技术

Automated 3D Printing-Based Non-Sterile Compounding Technology for Pediatric Corticosteroid Dosage Forms in a Health System Pharmacy Setting.

作者信息

Bernhardt M Brooke, Shokraneh Farnaz, Hrizanovska Ludmila, Lahtinen Julius, Brasher Cynthia A, Sandler Niklas

机构信息

Department of Pharmacy and Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, TN 38105, USA.

CurifyLabs Oy, Salmisaarenaukio 1, 00180 Helsinki, Finland.

出版信息

Pharmaceutics. 2025 Jun 9;17(6):762. doi: 10.3390/pharmaceutics17060762.

Abstract

Pharmaceutical compounding remains a predominantly manual process with limited innovation, particularly in non-sterile applications. This study explores the implementation of an automated compounding platform based on 3D printing to enhance precision, efficiency, and adaptability in pediatric corticosteroid formulations. Personalized hydrocortisone dosage forms were prepared in a hospital pharmacy setting using a proprietary excipient base and standardized procedures, including automated dosing and syringe heating when required. Three dosage forms-3.2 mg gel tablets, 2.8 mg water-free troches, and 1.2 mg orodispersible films (ODFs)-were selected to demonstrate the platform's versatility and to address pediatric needs for varying strengths and dosage types. All products were prepared using a reproducible semi-solid extrusion (SSE)-based workflow with the consistent API-excipient blending and automated deposition. Analytical testing confirmed that all formulations met pharmacopeial criteria for mass and content uniformity. The ODF and troche forms achieved rapid drug release, exceeding 75% within 5 min, while the gel tablet showed a slower release profile, reaching 86% by 60 min. Additionally, in-process homogeneity testing across syringe printing cycles confirmed the consistent API distribution. : The results support the feasibility of integrating automated compounding technologies into pharmacy workflows. Such systems can improve accuracy, minimize variability, and streamline the production of customized pediatric medications, particularly for drugs with poor palatability or narrow therapeutic windows. Overall, this study highlights the potential of automation to modernize non-sterile compounding, and to better support individualized therapy.

摘要

药物配制仍然主要是一个手工过程,创新有限,尤其是在非无菌应用方面。本研究探索了基于3D打印的自动化配制平台的实施,以提高儿科皮质类固醇制剂的精度、效率和适应性。在医院药房环境中,使用专有的辅料基质和标准化程序制备个性化氢化可的松剂型,包括自动给药和必要时的注射器加热。选择了三种剂型——3.2毫克凝胶片、2.8毫克无水含片和1.2毫克口腔崩解膜(ODF)——以展示该平台的多功能性,并满足儿科对不同强度和剂型的需求。所有产品均采用基于可重复的半固体挤出(SSE)工作流程制备,具有一致的原料药-辅料混合和自动沉积。分析测试证实,所有制剂均符合药典的质量和含量均匀度标准。ODF和含片剂型实现了快速药物释放,5分钟内超过75%,而凝胶片显示出较慢的释放曲线,60分钟时达到86%。此外,在注射器打印周期内进行的过程均匀性测试证实了原料药的分布一致。结果支持将自动化配制技术整合到药房工作流程中的可行性。这样的系统可以提高准确性,最大限度地减少变异性,并简化定制儿科药物的生产,特别是对于口感差或治疗窗窄的药物。总体而言,本研究强调了自动化使非无菌配制现代化以及更好地支持个体化治疗的潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba8c/12197057/a6d2b3b46aa0/pharmaceutics-17-00762-g001.jpg

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