Pyteraf Jolanta, Pacławski Adam, Jamróz Witold, Mendyk Aleksander, Paluch Marian, Jachowicz Renata
Department of Pharmaceutical Technology and Biopharmaceutics, Jagiellonian University Medical College, Medyczna 9, 30-688 Krakow, Poland.
A. Chełkowski Institute of Physics, University of Silesia in Katowice, ul. 75 Pułku Piechoty 1, 41-500 Chorzów, Poland.
Pharmaceutics. 2022 Apr 12;14(4):843. doi: 10.3390/pharmaceutics14040843.
Additive technologies have undoubtedly become one of the most intensively developing manufacturing methods in recent years. Among the numerous applications, the interest in 3D printing also includes its application in pharmacy for production of small batches of personalized drugs. For this reason, we conducted multi-stage pre-formulation studies to optimize the process of manufacturing solid dosage forms by photopolymerization with visible light. Based on tests planned and executed according to the design of the experiment (DoE), we selected the optimal quantitative composition of photocurable resin made of PEG 400, PEGDA MW 575, water, and riboflavin, a non-toxic photoinitiator. In subsequent stages, we adjusted the printer set-up and process parameters. Moreover, we assessed the influence of the co-initiators ascorbic acid or triethanolamine on the resin's polymerization process. Next, based on an optimized formulation, we printed and analyzed drug-loaded tablets containing mebeverine hydrochloride, characterized by a gradual release of active pharmaceutical ingredient (API), reaching 80% after 6 h. We proved the possibility of reusing the drug-loaded resin that was not hardened during printing and determined the linear correlation between the volume of the designed tablets and the amount of API, confirming the possibility of printing personalized modified-release tablets.
增材制造技术无疑已成为近年来发展最为迅猛的制造方法之一。在众多应用中,对3D打印的兴趣还包括其在制药领域用于小批量生产个性化药物。因此,我们进行了多阶段的处方前研究,以优化通过可见光光聚合制造固体剂型的工艺。基于根据实验设计(DoE)规划和执行的测试,我们选择了由聚乙二醇400(PEG 400)、分子量575的聚乙二醇二丙烯酸酯(PEGDA MW 575)、水和无毒光引发剂核黄素制成的光固化树脂的最佳定量组成。在后续阶段,我们调整了打印机设置和工艺参数。此外,我们评估了共引发剂抗坏血酸或三乙醇胺对树脂聚合过程的影响。接下来,基于优化后的配方,我们打印并分析了含有盐酸美贝维林的载药片剂,其特点是活性药物成分(API)逐渐释放,6小时后达到80%。我们证明了重复使用打印过程中未硬化的载药树脂的可能性,并确定了设计片剂的体积与API量之间的线性相关性,证实了打印个性化缓释片剂的可能性。