Rodríguez-Maciñeiras Xela, Bendicho-Lavilla Carlos, Rial Carlos, Garba-Mohammed Khalid, Worsley Anna, Díaz-Torres Eduardo, Orive-Martínez Celia, Orive-Mayor Ángel, Basit Abdul W, Alvarez-Lorenzo Carmen, Goyanes Alvaro
Departamento de Farmacología, Farmacia y Tecnología Farmacéutica, I+D Farma (GI-1645), Facultad de Farmacia, Instituto de Materiales (iMATUS) and Health Research Institute of Santiago de Compostela (IDIS), Universidade de Santiago de Compostela, 15782 Santiago de Compostela, Spain; FABRX Artificial Intelligence, Carretera de Escairón, 14, Currelos (O Saviñao) CP 27543, Spain.
FABRX Artificial Intelligence, Carretera de Escairón, 14, Currelos (O Saviñao) CP 27543, Spain; FABRX Ltd., Henwood House, Henwood, Ashford, Kent TN24 8DH, UK.
Int J Pharm. 2025 Feb 25;671:125251. doi: 10.1016/j.ijpharm.2025.125251. Epub 2025 Jan 23.
Compounding medications in pharmacies is a common practice for patients with prescriptions that are not available commercially, but it is a laborious and error-prone task. The incorporation of emerging technologies to prepare personalised medication, such as 3D printing, has been delayed in smaller pharmacies due to concerns about potential workflow disruptions and learning curves associated with novel technologies. This study examines the use in a community pharmacy of a pharmaceutical 3D printer to auto-fill capsules and blisters using semisolid extrusion, incorporating an integrated quality control system. This retains the customisation and automation advantages of 3D printing, speeding up the manufacturing process while increasing familiarity for pharmacists. Minoxidil capsules (2.5 mg and 5 mg doses) were prepared using a pharmaceutical 3D printer and dispensed to 9 patients in a community compounding pharmacy setting in Spain. This innovative production method was compared to the conventional manual capsule filling. All capsules met the European Pharmacopeia standards for mass uniformity, drug content and dissolution, and demonstrated stability at 25 °C and 65 % relative humidity for three months, matching the typical treatment duration. The 3D printer offers greater precision and efficiency and reduced operator involvement by more than half compared to manual capsule filling, making the process faster and more cost-effective. This study offers for the first time a clear roadmap for implementing a pharmaceutical 3D printer in a community pharmacy for automated compounding to prepare reliable and precise personalised medication for patients, marking a valuable step forward in precision medicine.
对于那些需要使用市面上没有的处方药的患者来说，在药房配制药物是一种常见的做法，但这是一项费力且容易出错的任务。由于担心新技术可能会扰乱工作流程以及存在与新技术相关的学习曲线，在较小的药房中，将新兴技术（如3D打印）用于制备个性化药物的进程一直被推迟。本研究考察了在一家社区药房中使用一台制药3D打印机，通过半固体挤出法自动填充胶囊和水泡眼包装，并集成了质量控制系统。这保留了3D打印的定制化和自动化优势，加快了生产过程，同时增加了药剂师对其的熟悉程度。使用一台制药3D打印机制备了米诺地尔胶囊（2.5毫克和5毫克剂量），并在西班牙一家社区配制药房环境中配发给了9名患者。将这种创新的生产方法与传统的手动胶囊填充方法进行了比较。所有胶囊均符合欧洲药典关于质量均匀性、药物含量和溶出度的标准，并在25℃和65%相对湿度条件下稳定保存了三个月，这与典型的治疗持续时间相符。与手动胶囊填充相比，3D打印机具有更高的精度和效率，且操作人员的参与度降低了一半以上，使得这个过程更快且更具成本效益。本研究首次为在社区药房中实施制药3D打印机以进行自动化配制从而为患者制备可靠且精确的个性化药物提供了清晰的路线图，这标志着精准医学向前迈出了宝贵的一步。
