Santamaría Karla J, Anaya Brayan J, Lalatsa Aikaterini, González-Barranco Patricia, Cantú-Cárdenas Lucía, Serrano Dolores R
Pharmaceutics and Food Technology Department, Faculty of Pharmacy, Complutense University of Madrid, 28040 Madrid, Spain.
School of Chemistry, Autonomous University of Nuevo León Monterrey, Monterrey 66455, Mexico.
Gels. 2024 Sep 26;10(10):620. doi: 10.3390/gels10100620.
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.
在当今的制药领域,迫切需要开发新的药物递送系统,这些系统在确保治疗依从性方面具有吸引力且有效,尤其是在儿科患者中。医学领域3D打印技术的出现正在彻底改变这一领域,它能够制造出精确、可定制且外观吸引人的剂型。在本研究中,我们基于半固体挤出(SSE)3D打印技术生产了250毫克的二甲双胍儿科软糖。一种含有二甲双胍的药用油墨被成功配制,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3D打印和浇铸方法进行了比较。3D打印的软糖表现出更好的硬度,并在早期实现持续释放,以避免二甲双胍在口腔中释放并确保口感。其质地和外观与市售软糖相匹配。总之,SSE使得成功制造用于治疗儿科糖尿病患者的3D打印无糖软糖成为可能,并且是一种易于转化应用于临床实践的方法。