Ayyoubi Sejad, Ruijgrok Liesbeth, van der Kuy Hugo, Ten Ham Renske, Thielen Frederick
Department of Hospital Pharmacy, Erasmus University Medical Center, Dr Molewaterplein 40, Room Number: na-219, 3015 GD, Rotterdam, The Netherlands.
Department of Epidemiology & Health Economics, Julius Center, University Medical Center Utrecht, Universiteitsweg 100, 3584 CX, Utrecht, The Netherlands.
Pharmacoecon Open. 2025 Mar;9(2):207-215. doi: 10.1007/s41669-024-00551-1. Epub 2024 Dec 30.
Pharmaceutical three-dimensional printing (3DP) technology offers an automated platform that can be utilized to manufacture personalized medicine, improving pharmacotherapy. Although 3D-printed products have entered clinical trials, no costing studies have been performed yet. Cost insights can aid researchers and industry in making informed decisions about the feasibility and scalability of 3DP.
The aim of this research was therefore to develop a framework that can be utilized to estimate the manufacturing cost of one 3D tablet in a hospital pharmacy setting.
To develop the costing framework, general manufacturing phases were identified, consisting of (i) pre-printing, (ii) printing, and (iii) post-printing. For each phase, cost categories were defined, including personnel, materials, equipment, facility, and quality assurance. The three phases combined with the categories formed the base of the costing framework. An earlier developed 3D-printed hydrocortisone formulation (M3DICORT) was used as a case study. Costs were expressed in 2022 euros (€). The framework was applied to M3DICORT in four scenarios: a base case scenario, worst-case scenario, best-case scenario, and a scaling scenario. In the scaling scenario, we assumed that 3D inks were mass produced.
Costs of manufacturing a single M3DICORT tablet were €1.97-3.11 (best-case-worst-case) and €1.58-2.26 for the scaling scenario.
Manufacturing costs of 3D-printed pharmaceuticals were thus far unknown. The framework is translated into an open-access costing tool to facilitate adoption by other parties, and is also applicable for other pharmaceutical 3DP techniques.
药物三维打印（3DP）技术提供了一个自动化平台，可用于制造个性化药物，改善药物治疗。尽管3D打印产品已进入临床试验阶段，但尚未进行成本研究。成本分析有助于研究人员和行业就3DP的可行性和可扩展性做出明智决策。
因此，本研究的目的是开发一个框架，用于估算医院药房环境中一片3D片剂的制造成本。
为了开发成本核算框架，确定了一般制造阶段，包括（i）打印前、（ii）打印和（iii）打印后。对于每个阶段，定义了成本类别，包括人员、材料、设备、设施和质量保证。这三个阶段与成本类别共同构成了成本核算框架的基础。以先前开发的3D打印氢化可的松制剂（M3DICORT）作为案例研究。成本以2022年欧元（€）表示。该框架在四种情况下应用于M3DICORT：基础案例、最坏情况、最佳情况和规模扩大情况。在规模扩大情况下，我们假设3D油墨进行大规模生产。
制造一片M3DICORT片剂的成本在1.97 - 3.11欧元（最佳情况 - 最坏情况）之间，规模扩大情况下为1.58 - 2.26欧元。
迄今为止，3D打印药物的制造成本尚不清楚。该框架已转化为一个开放获取的成本核算工具，以方便其他方采用，并且也适用于其他药物3DP技术。
