Díaz-Torres Eduardo, Suárez-González Javier, Monzón-Rodríguez Cecilia N, Santoveña-Estévez Ana, Fariña José B
Departamento de Ingeniería Química y Tecnología Farmacéutica, Campus de Anchieta, Universidad de La Laguna (ULL), 38200 La Laguna, Tenerife, Spain.
Instituto Universitario de Enfermedades Tropicales y Salud Pública de Canarias, Universidad de La Laguna (ULL), Avenida Astrofísico Francisco Sánchez, s/n., 38200 La Laguna, Tenerife, Spain.
Pharmaceutics. 2023 Jun 2;15(6):1642. doi: 10.3390/pharmaceutics15061642.
3D printing technology can be used to develop individualized medicines in hospitals and pharmacies, allowing a high degree of personalization and the possibility to adjust the dose of the API based on the quantity of material extruded. The main goal of incorporating this technology is to have a stock of API-load print cartridges that could be used at different storage times and for different patients. However, it is necessary to study the extrudability, stability, and buildability of these print cartridges during storage time. A paste-like formulation containing hydrochlorothiazide as a model drug was prepared and distributed in five print cartridges, each of which was studied for different storage times (0 h-72 h) and conditions, for repeated use on different days. For each print cartridge, an extrudability analysis was performed, and subsequently, 100 unit forms of 10 mg hydrochlorothiazide were printed. Finally, various dosage units containing different doses were printed, taking into account the optimized printing parameters based on the results of the extrudability analysis carried out previously. An appropriate methodology for the rapid development of appropriate SSE 3DP inks for pediatrics was established and evaluated. The extrudability analysis and several parameters allowed the detection of changes in the mechanical behavior of the printing inks, the pressure interval of the steady flow, and the selection of the volume of ink to be extruded to obtain each of the required doses. The print cartridges were stable for up to 72 h after processing, and orodispersible printlets containing 6 mg to 24 mg of hydrochlorothiazide can be produced using the same print cartridge and during the same printing process with guaranteed content and chemical stability. The proposed workflow for the development of new printing inks containing APIs will allow the optimization of feedstock material and human resources in pharmacy or hospital pharmacy services, thus speeding up their development and reducing costs.
3D打印技术可用于医院和药房开发个性化药物，实现高度个性化，并可根据挤出材料的量调整活性药物成分（API）的剂量。采用这项技术的主要目的是储备可在不同储存时间供不同患者使用的含API打印墨盒。然而，有必要研究这些打印墨盒在储存期间的挤出性、稳定性和可制造性。制备了一种含氢氯噻嗪作为模型药物的膏状制剂，并分装在五个打印墨盒中，每个墨盒针对不同的储存时间（0小时至72小时）和条件进行研究，以便在不同日期重复使用。对每个打印墨盒进行挤出性分析，随后打印出100个10毫克氢氯噻嗪的单位剂型。最后，根据先前挤出性分析的结果，考虑优化的打印参数，打印出含有不同剂量的各种剂型。建立并评估了一种用于快速开发适合儿科的固态挤出3D打印油墨的适当方法。挤出性分析和几个参数能够检测打印油墨机械性能的变化、稳定流动的压力区间，以及选择要挤出的油墨体积以获得每种所需剂量。打印墨盒在加工后长达72小时内保持稳定，使用同一个打印墨盒并在同一打印过程中可生产出含6毫克至24毫克氢氯噻嗪的口腔崩解打印片，且含量和化学稳定性有保证。所提出的含API新型打印油墨开发工作流程将优化药房或医院药房服务中的原料和人力资源，从而加快其开发并降低成本。
