Okwuosa Tochukwu C, Pereira Beatriz C, Arafat Basel, Cieszynska Milena, Isreb Abdullah, Alhnan Mohamed A
School of Pharmacy and Biomedical Sciences, University of Central Lancashire, Preston, Lancashire, UK.
Pharm Res. 2017 Feb;34(2):427-437. doi: 10.1007/s11095-016-2073-3. Epub 2016 Dec 9.
Individualizing gastric-resistant tablets is associated with major challenges for clinical staff in hospitals and healthcare centres. This work aims to fabricate gastric-resistant 3D printed tablets using dual FDM 3D printing.
The gastric-resistant tablets were engineered by employing a range of shell-core designs using polyvinylpyrrolidone (PVP) and methacrylic acid co-polymer for core and shell structures respectively. Filaments for both core and shell were compounded using a twin-screw hot-melt extruder (HME). CAD software was utilized to design a capsule-shaped core with a complementary shell of increasing thicknesses (0.17, 0.35, 0.52, 0.70 or 0.87 mm). The physical form of the drug and its integrity following an FDM 3D printing were assessed using x-ray powder diffractometry (XRPD), thermal analysis and HPLC.
A shell thickness ≥0.52 mm was deemed necessary in order to achieve sufficient core protection in the acid medium. The technology proved viable for incorporating different drug candidates; theophylline, budesonide and diclofenac sodium. XRPD indicated the presence of theophylline crystals whilst budesonide and diclofenac sodium remained amorphous in the PVP matrix of the filaments and 3D printed tablets. Fabricated tablets demonstrated gastric resistant properties and a pH responsive drug release pattern in both phosphate and bicarbonate buffers.
Despite its relatively limited resolution, FDM 3D printing proved to be a suitable platform for a single-process fabrication of delayed release tablets. This work reveals the potential of dual FDM 3D printing as a unique platform for personalising delayed release tablets to suit an individual patient's needs.
为医院和医疗保健中心的临床工作人员定制耐胃酸片剂面临重大挑战。这项工作旨在使用双FDM 3D打印技术制造耐胃酸的3D打印片剂。
通过采用一系列壳-核设计来制造耐胃酸片剂，分别使用聚乙烯吡咯烷酮（PVP）和甲基丙烯酸共聚物作为核结构和壳结构。核和壳的长丝均使用双螺杆热熔挤出机（HME）进行复合。利用CAD软件设计了一种胶囊形状的核，并带有厚度逐渐增加（0.17、0.35、0.52、0.70或0.87毫米）的互补壳。使用X射线粉末衍射仪（XRPD）、热分析和高效液相色谱法评估了药物的物理形态及其在FDM 3D打印后的完整性。
为了在酸性介质中实现对核心的充分保护，壳厚度≥0.52毫米被认为是必要的。该技术被证明可用于掺入不同的候选药物；茶碱、布地奈德和双氯芬酸钠。XRPD表明存在茶碱晶体，而布地奈德和双氯芬酸钠在长丝和3D打印片剂的PVP基质中保持无定形。制造的片剂在磷酸盐和碳酸氢盐缓冲液中均表现出耐胃酸特性和pH响应药物释放模式。
尽管其分辨率相对有限，但FDM 3D打印被证明是一种适合单步制造缓释片剂的平台。这项工作揭示了双FDM 3D打印作为一个独特平台的潜力，可用于定制缓释片剂以满足个体患者的需求。
