Department of Pharmaceutical Sciences, School of Pharmacy, Texas Tech University Health Sciences Center, 1300 Coulter Dr., Amarillo, TX 79106, United States of America; Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Al-Azhar University, Cairo 11651, Egypt.
Department of Industrial, Manufacturing, and Systems Engineering, Texas Tech University, Lubbock, TX 79409-3061, United States of America.
Eur J Pharm Sci. 2019 Jul 1;135:60-67. doi: 10.1016/j.ejps.2019.05.008. Epub 2019 May 17.
In this study, we assessed the feasibility of using digital light processing (DLP) 3D printers (3DP) in fabrication of solid oral dosage forms. The DLP technology uses a digital micromirror device (DMD) that reflects and focuses ultraviolet (UV) light on the surfaces of photoreactive materials that polymerize in a layer-by-layer fashion. Using poly(ethylene glycol) diacrylate (PEGDA) and poly(ethylene glycol) dimethacrylate (PEGDMA) as photoreactive polymers and theophylline as a model drug, we deployed a DLP printer to fabricate tablets. After optimizing various printing parameters including UV intensity and exposure time, layer thickness, and polymer concentration, we printed various types of tablets with and without perforation. We then assessed the tablets for drug content, mechanical strengths, swellability, weight variation, microscopic features, drug-polymer interactions and drug release profiles. The loading of theophylline was 1%, which was independent of tablet weights. The drug content and weight variation were within the acceptable range, as recommended by the United States Pharmacopeia (USP). Scanning electronic microscopic (SEM) pictures showed tablets with distinct layers and smooth outer surfaces. The spectral scans, obtained using Fourier Transform Infrared Spectroscopy (FTIR), showed no chemical interactions between the drug and polymers. Similarly, drug content determined using a UV spectrophotometer was the same as that determined by a high performance liquid chromatography (UPLC). The extent of drug release increased with the increase in the number of perforations in the tablets. Overall, this study demonstrates that DLP 3DP can be used as a platform for fabricating oral tablets with well-defined shapes and different release profiles.
在这项研究中,我们评估了使用数字光处理(DLP)3D 打印机(3DP)制造固体口服剂型的可行性。DLP 技术使用数字微镜器件(DMD),该器件反射和聚焦紫外(UV)光在逐层聚合的光反应材料的表面上。我们使用聚乙二醇二丙烯酸酯(PEGDA)和聚乙二醇二甲基丙烯酸酯(PEGDMA)作为光反应聚合物,以茶碱作为模型药物,使用 DLP 打印机制造片剂。在优化了各种打印参数(包括 UV 强度和曝光时间、层厚和聚合物浓度)之后,我们打印了具有和不具有穿孔的各种类型的片剂。然后,我们评估了片剂的药物含量、机械强度、溶胀性、重量变化、微观特征、药物-聚合物相互作用和药物释放曲线。茶碱的负载量为 1%,与片剂重量无关。药物含量和重量变化均在可接受范围内,符合美国药典(USP)的建议。扫描电子显微镜(SEM)照片显示片剂具有明显的层状结构和光滑的外表面。使用傅里叶变换红外光谱(FTIR)获得的光谱扫描显示药物与聚合物之间没有化学相互作用。同样,使用紫外分光光度计测定的药物含量与使用高效液相色谱(UPLC)测定的药物含量相同。随着片剂穿孔数量的增加,药物释放的程度也随之增加。总体而言,这项研究表明,DLP 3DP 可作为制造具有明确形状和不同释放曲线的口服片剂的平台。