Karla J Santamaría, Brayan J Anaya, Aikaterini Lalatsa, Patricia González-Barranco, Lucía Cantú-Cárdenas, Dolores R Serrano
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引用次数: 0
摘要
在当今的制药领域,迫切需要开发出既吸引人又能有效确保治疗依从性的新型给药系统,尤其是在儿科患者中。3D打印技术在医药领域的出现为这一领域带来了革命性的变化,它可以制造出精确、可定制且外观精美的剂型。在这项研究中,我们采用半固态挤压(SSE)3D 打印技术制作了 250 毫克二甲双胍儿科软糖。含有二甲双胍的药用油墨配制成功,具有适合室温打印的最佳流动特性。采用质量源于设计的方法,对三维打印和铸造方法进行了比较。三维打印软糖具有更好的硬度,并能在更早的时间内持续释放二甲双胍,从而避免二甲双胍在口腔中释放,并确保其适口性。其质地和物理外观与市面上销售的软糖一致。总之,SSE 成功制造出用于治疗儿科糖尿病的 3D 打印无糖软糖,是一种易于转化为临床实践的方法。
Engineering 3D Printed Gummies Loaded with Metformin for Paediatric Use.
In today's pharmaceutical landscape, there's an urgent need to develop new drug delivery systems that are appealing and effective in ensuring therapeutic adherence, particularly among paediatric patients. The advent of 3D printing in medicine is revolutionizing this space by enabling the creation of precise, customizable, and visually appealing dosage forms. In this study, we produced 250 mg metformin paediatric gummies based on the semi-solid extrusion (SSE) 3D printing technique. A pharmaceutical ink containing metformin was successfully formulated with optimal flow properties suitable for room-temperature printing. Using a quality by design approach, 3D printing and casting methodologies were compared. The 3D-printed gummies exhibited better firmness and sustained release at earlier times to avoid metformin release in the oral cavity and ensure palatability. The texture and physical appearance match those of gummies commercially available. In conclusion, SSE allowed for the successful manufacture of 3D-printed sugar-free gummies for the treatment of diabetes mellitus for paediatric patients and is an easily translatable approach to clinical practice.