3D printed tacrolimus suppositories for the treatment of ulcerative colitis  

作　　者：Iria Seoane-Viano Jun Jie Ong Asteria Luzardo-Alvarez Miguel Gonzalez-Barcia Abdul W.Basit Francisco J.Otero-Espinar Alvaro Goyanes 

机构地区：[1]Department of Pharmacology,Pharmacy and Pharmaceutical Technology,Faculty of Pharmacy,University of Santiago de Compostela,Santiago de Compostela 15782,Spain [2]Department of Pharmaceutics,UCL School of Pharmacy,University College London,London WC1N 1AX,UK [3]Pharmacy Department,University Clinical Hospital Santiago de Compostela(SERGAS)(CHUS),Santiago de Compostela 15706,Spain [4]FabRx Ltd.,Ashford,Kent TN240RW,UK [5]Departamento de Farmacologia,Farmacia y Tecnologia Farmaceutica,I+D Farma Group(GI-1645),Universidade de Santiago de Compostela,Santiago de Compostela 15782,Spain

出　　处：《Asian Journal of Pharmaceutical Sciences》2021年第1期110-119,共10页亚洲药物制剂科学（英文）

基　　金：funded by Xunta de Galicia grant number GRC2013/015 and GPC2017/015.

摘　　要：Ulcerative colitis is a global health problem,affecting millions of individuals worldwide.As an inflammatory condition localised in the large intestine,rectal delivery of immunosuppressive therapies such as tacrolimus is a promising strategy to maximise drug concentration at the site of action whilst minimising systemic side effects.Here,for the first time,self-supporting 3D-printed tacrolimus suppositories were prepared without the aid of moulds using a pharmaceutical semi-solid extrusion(SSE)3D printer.The suppositories were printed vertically in three different sizes using combinations of two lipid pharmaceutical excipients(Gelucire 44/14 or Gelucire 48/16)and coconut oil.Although both suppository formulations had the appropriate viscosity characteristics for printing,the Gel 44 formulation required less energy and force for extrusion compared to the Gel 48 system.The Gel 44 disintegrated more rapidly but released tacrolimus more slowly than the Gel 48 suppositories.Although the tacrolimus release profiles were significantly different,both suppository systems released more than 80% drug within 120 min.DSC and XRD analysis was inconclusive in determining the solid-state properties of the drug in the suppositories.In summary,this article reports on the fabrication of 3D printed selfsupporting suppositories to deliver personalised doses of a narrow therapeutic index drug,with potential benefits for patients with ulcerative colitis.

关 键 词：3D printed drug products Semi-solid extrusion 3D printing Inflammatory bowel disease Suppository drug delivery Pressure assisted syringe M3dimaker 

分 类 号：R57[医药卫生—消化系统]