The costs of pharmaceutical 3D printing using Semi-solid extrusion 3D printing (SSE)A case study with hydrocortisone for adrenal insufficiency

Abstract

The traditional pharmaceutical manufacturing of small molecule drugs in large quantities does not always address patient-specific requirements, thus necessitating personalized medicine. To take care of this, Semi-Solid Extrusion (SSE) 3D printing would offer a problem-solving approach by allowing drug formulation customization to achieve ideal therapeutic results. The scope of this study is to apply and modify an existing costing framework to the manufacture of 3D printed direct release hydrocortisone tablets using SSE at a detailed level, with the specific target group being patients with adrenal insufficiency. A detailed adjusted costing model was developed, breaking the process of 3DP down into three distinct phases: pre-printing, printing, and post-printing. Specific cost categories were identified for all the phases which include the costs of materials, equipment, personnel, QA, and facility costs. The analysis used a micro-costing approach, and it was conducted from the Erasmus MC academic hospital pharmacy. The total cost per tablet was calculated over a range of scenarios – base-case, best- and worst-case, and scaling manufacturer scenarios – and different types of input costs were assumed. The cost per tablet was €5.11, €6.62, and €2.91 for base, worst- and best-case scenarios, respectively. Costs for scaling scenarios ranged in cost from €1.27 to €1.45 per tablet. These were compared to standard commercially available compounded hydrocortisone capsules that cost €9.00 per capsule, demonstrating the economic potential of SSE, albeit that it required further development at industrial scale up. Even though SSE has higher overall costs and material waste in the beginning, a full comparison with FDM in detail suggests that SSE can achieve cost-effectiveness through upscaling and better resource allocation leading to large-scale cost savings. Future strategic investments and continued research to optimize SSE-related processes will lead to large-scale cost efficiencies that could unblock the true potential of this technology, directly improving patient outcomes and advancing precision medicine while reducing the costs of healthcare delivery.