Faculty of Engineering and Science, School of Science, University of Greenwich, Medway Campus, Chatham Maritime, Kent, ME4 4TB, UK.
Pharm Res. 2018 Jan 16;35(2):34. doi: 10.1007/s11095-017-2284-2.
Three- dimensional (3D) printing has received significant attention as a manufacturing process for pharmaceutical dosage forms. In this study, we used Fusion Deposition Modelling (FDM) in order to print "candy - like" formulations by imitating Starmix® sweets to prepare paediatric medicines with enhanced palatability.
Hot melt extrusion processing (HME) was coupled with FDM to prepare extruded filaments of indomethacin (IND), hypromellose acetate succinate (HPMCAS) and polyethylene glycol (PEG) formulations and subsequently feed them in the 3D printer. The shapes of the Starmix® objects were printed in the form of a heart, ring, bottle, ring, bear and lion. Differential scanning calorimetry (DSC), X-ray powder diffraction (XRPD), Fourier Transform Infra-red Spectroscopy (FT-IR) and confocal Raman analysis were used to assess the drug - excipient interactions and the content uniformity.
Physicochemical analysis showed the presence of molecularly dispersed IND in the printed tablets. In vivo taste masking evaluation demonstrated excellent masking of the drug bitterness. The printed forms were evaluated for drug dissolution and showed immediate IND release independently of the printed shape, within 60 min.
3D printing was used successfully to process drug loaded filaments for the development of paediatric printed tablets in the form of Starmix® designs.
三维（3D）打印作为一种制药剂型的制造工艺受到了广泛关注。在本研究中，我们使用熔融沉积成型（FDM）通过模仿 StarMix®糖果来打印“糖果状”制剂，从而制备具有增强口感的儿科药物。
热熔挤出加工（HME）与 FDM 相结合，用于制备吲哚美辛（IND）、醋酸羟丙甲纤维素琥珀酸酯（HPMCAS）和聚乙二醇（PEG）制剂的挤出长丝，然后将其送入 3D 打印机。StarMix®物体的形状以心形、环、瓶、环、熊和狮子的形式打印。差示扫描量热法（DSC）、X 射线粉末衍射（XRPD）、傅里叶变换红外光谱（FT-IR）和共聚焦拉曼分析用于评估药物-赋形剂相互作用和含量均匀性。
物理化学分析表明，打印片剂中存在分子分散的 IND。体内味觉掩蔽评估表明药物苦味得到了极好的掩蔽。对打印形式进行了药物溶出度评估，结果表明，无论打印形状如何，60 分钟内均可迅速释放 IND。
成功地使用 3D 打印处理载药长丝，以 StarMix®设计的形式开发儿科打印片剂。
