Centro de Innovación en Química Avanzada (ORFEO-CINQA), Instituto Universitario de Química Organometálica "Enrique Moles", Departamento de Química Orgánica e Inorgánica, Universidad de Oviedo, C/ Julián Clavería, 8, 33006 Oviedo, Asturias, Spain; Fundación Idonial, Parque Científico y Tecnológico de Gijón, Avda. Jardín Botánico, 1345, 33203 Gijón, Asturias, Spain.
Centro de Innovación en Química Avanzada (ORFEO-CINQA), Instituto Universitario de Química Organometálica "Enrique Moles", Departamento de Química Orgánica e Inorgánica, Universidad de Oviedo, C/ Julián Clavería, 8, 33006 Oviedo, Asturias, Spain; Fundación Idonial, Parque Científico y Tecnológico de Gijón, Avda. Jardín Botánico, 1345, 33203 Gijón, Asturias, Spain.
Int J Pharm. 2020 Sep 25;587:119687. doi: 10.1016/j.ijpharm.2020.119687. Epub 2020 Jul 27.
Obtention of customized dosage forms is one of the main attractions of 3D printing in pharmaceuticals. In this sense, children are one of the groups within the population with a greater need for drug doses adapted to their requirements (age, weight, pathological state…), but most 3D printed oral dosages are solid forms and, therefore, not suitable for them. This work developed patient-tailored medicinal gummies, an alternative oral dosage form with eye-catching appearance and appropriate organoleptic characteristics. Four inks were formulated, characterised and 3D printed by means of syringe-based extrusion mechanism. Different tests were performed to ensure reproducibility of the process and validate work methodology for dosage unit fabrication applying basic manufacturing standards. Rheological test helped in evaluating inks printability. Visual characterization concluded that drugmies, apart from a high fidelity in the 3D model shape reproduction, had a bright and uniformly coloured appearance and a pleasant aroma, which made them highly appetising and attractive. The printed gummy oral dosages complied comfortably with the mass uniformity assay regardless of the formulated ink used or the 3D model selected for printing. Ranitidine hydrochloride individual contents were determined using uv-vis spectrophotometry, showing successful results both in dose accuracy, uniformity of drug content and dissolution.
获得定制剂量形式是 3D 打印在制药中的主要吸引力之一。从这个意义上说，儿童是人群中对适应其需求的药物剂量（年龄、体重、病理状态等）有更大需求的群体之一，但大多数 3D 打印的口服剂量都是固体形式，因此不适合他们。这项工作开发了适合患者的药用软糖，这是一种具有吸引力外观和适当感官特性的替代口服剂型。通过基于注射器的挤压机制，配制、表征和 3D 打印了四种油墨。进行了不同的测试，以确保该过程的可重复性，并应用基本制造标准验证用于剂量单位制造的工作方法。流变学测试有助于评估油墨的可印刷性。视觉特征分析表明，除了对 3D 模型形状的高保真度再现外，药物微丸还具有明亮且均匀着色的外观和宜人的香气，使它们非常开胃和吸引人。无论使用哪种配方油墨或为打印选择的 3D 模型，所打印的盐酸雷尼替丁口服 gummy 剂量都能轻松满足质量均匀性测定。使用紫外可见分光光度法测定盐酸雷尼替丁的个体含量，结果表明剂量准确性、药物含量均匀性和溶出度均取得了成功。
