Arany Petra, Papp Ildikó, Zichar Marianna, Regdon Géza, Béres Mónika, Szalóki Melinda, Kovács Renátó, Fehér Pálma, Ujhelyi Zoltán, Vecsernyés Miklós, Bácskay Ildikó
Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Debrecen, Nagyerdei Körút 98, H-4032 Debrecen, Hungary.
Doctoral School of Pharmaceutical Sciences, University of Debrecen, Nagyerdei Körút 98, H-4032 Debrecen, Hungary.
Pharmaceutics. 2021 Oct 16;13(10):1714. doi: 10.3390/pharmaceutics13101714.
Vaginal drug delivery systems can provide a long-term and constant liberation of the active pharmaceutical ingredient even for months. For our experiment, FDM 3D printing was used to manufacture the vaginal ring samples from thermoplastic polyurethane filament, which enables fast manufacturing of complex, personalized medications. 3D printing can be an excellent alternative instead of industrial manufacturing, which is complicated and time-consuming. In our work, the 3D printed vaginal rings were filled manually with jellified metronidazole or chloramphenicol for the treatment of bacterial vaginosis. The need for manual filling was certified by the thermogravimetric and heatflow assay results. The manufactured samples were analyzed by an Erweka USP type II Dissolution Apparatus, and the dissolution profile can be distinguished based on the applied jellifying agents and the API's. All samples were considered non-similar based on the pairwise comparison. The biocompatibility properties were determined by prolonged MTT assay on HeLa cells, and the polymer could be considered non-toxic. Based on the microbiological assay on metronidazole and chitosan containing samples had bactericidal effects while just metronidazole or just chitosan containing samples bacteriostatic effect. None of these samples showed a fungistatic or fungicide effect against Based on our results, we successfully manufactured 3D printed vaginal rings filled with jellified metronidazole.
阴道给药系统能够使活性药物成分长期持续释放,甚至长达数月。在我们的实验中,采用熔融沉积成型(FDM)3D打印技术,用热塑性聚氨酯长丝制造阴道环样品,这能够快速制造复杂的个性化药物。3D打印可以成为替代复杂且耗时的工业制造的绝佳选择。在我们的工作中,3D打印的阴道环通过手动填充凝胶化的甲硝唑或氯霉素来治疗细菌性阴道病。热重分析和热流分析结果证实了手动填充的必要性。用Erweka USP II型溶出度测定仪对制造的样品进行分析,根据所使用的凝胶化剂和活性药物成分,可以区分溶出曲线。基于成对比较,所有样品均被认为不相似。通过对HeLa细胞进行延长的MTT试验来测定生物相容性,该聚合物可被认为无毒。基于对含甲硝唑和壳聚糖样品的微生物学分析,含甲硝唑和壳聚糖的样品具有杀菌作用,而仅含甲硝唑或仅含壳聚糖的样品具有抑菌作用。这些样品均未显示出对……的抑真菌或杀真菌作用。基于我们的结果,我们成功制造出了填充有凝胶化甲硝唑的3D打印阴道环。