Sandler Topelius Niklas, Shokraneh Farnaz, Bahman Mahsa, Lahtinen Julius, Hassinen Niko, Airaksinen Sari, Verma Soumya, Hrizanovska Ludmila, Lass Jana, Paaver Urve, Tähnas Janika, Kern Catharina, Lagarce Frederic, Fenske Dominic, Malik Julia, Scherliess Holger, Cruz Sara P, Paulsson Mattias, Dekker Jan, Kammonen Katja, Rautamo Maria, Lück Hendrik, Pierrot Antoine, Stareprawo Stephanie, Tubic-Grozdanis Marija, Zibolka Stefanie, Lösch Uli, Jeske Martina, Griesser Ulrich, Hummer Karin, Thalmeier Andreas, Harjans Anna, Kruse Alexander, Heimke-Brinck Ralph, Khoukh Karim, Bruno Fabien
CurifyLabs Oy, Salmisaarenaukio 1, 00180 Helsinki, Finland.
Pharmaceutical Sciences Laboratory, Åbo Akademi University, Artillerigatan 6A, 02520 Turku, Finland.
Pharmaceutics. 2024 May 17;16(5):678. doi: 10.3390/pharmaceutics16050678.
Pharmacy compounding, the art and science of preparing customized medications to meet individual patient needs, is on the verge of transformation. Traditional methods of compounding often involve manual and time-consuming processes, presenting challenges in terms of consistency, dosage accuracy, quality control, contamination, and scalability. However, the emergence of cutting-edge technologies has paved a way for a new era for pharmacy compounding, promising to redefine the way medications are prepared and delivered as pharmacy-tailored personalized medicines. In this multi-site study, more than 30 hospitals and community pharmacies from eight countries in Europe utilized a novel automated dosing approach inspired by 3D printing for the compounding of non-sterile propranolol hydrochloride tablets. CuraBlend excipient base, a GMP-manufactured excipient base (pharma-ink) intended for automated compounding applications, was used. A standardized study protocol to test the automated dosing of tablets with variable weights was performed in all participating pharmacies in four different iterative phases. Integrated quality control was performed with an in-process scale and NIR spectroscopy supported by HPLC content uniformity measurements. In total, 6088 propranolol tablets were produced at different locations during this study. It was shown that the dosing accuracy of the process increased from about 90% to 100% from Phase 1 to Phase 4 by making improvements to the formulation and the hardware solutions. The results indicate that through this automated and quality controlled compounding approach, extemporaneous pharmacy manufacturing can take a giant leap forward towards automation and digital manufacture of dosage forms in hospital pharmacies and compounding pharmacies.
药学配制，即制备定制化药物以满足个体患者需求的艺术与科学，正处于变革的边缘。传统的配制方法通常涉及手工且耗时的过程，在一致性、剂量准确性、质量控制、污染和可扩展性方面存在挑战。然而，前沿技术的出现为药学配制的新时代铺平了道路，有望重新定义药物的制备和交付方式，使其成为药学定制的个性化药物。在这项多中心研究中，来自欧洲八个国家的30多家医院和社区药房采用了一种受3D打印启发的新型自动给药方法来配制非无菌盐酸普萘洛尔片。使用了CuraBlend辅料基质，这是一种用于自动配制应用的符合药品生产质量管理规范（GMP）生产的辅料基质（药物墨水）。在四个不同的迭代阶段，所有参与的药房都执行了一项标准化研究方案，以测试不同重量片剂的自动给药。通过在线秤和近红外光谱进行综合质量控制，并辅以高效液相色谱法含量均匀度测量。在这项研究期间，不同地点共生产了6088片普萘洛尔片。结果表明，通过改进配方和硬件解决方案，该过程的给药准确性从第1阶段到第4阶段从约90%提高到了100%。结果表明，通过这种自动化且质量可控的配制方法，医院药房和配制药房的临时药学制造在剂型的自动化和数字化制造方面可以向前迈出一大步。
