Sjöholm Erica, Mathiyalagan Rathna, Wang Xiaoju, Sandler Niklas
Pharmaceutical Sciences Laboratory, Faculty of Science and Engineering, Åbo Akademi University, Tykistökatu 6A, 20520 Turku, Finland.
Nanoform Finland Oyj, Viikinkaari 4, 00790 Helsinki, Finland.
Pharmaceutics. 2022 Jun 24;14(7):1339. doi: 10.3390/pharmaceutics14071339.
Certain patient populations receive insufficient medicinal treatment due to a lack of commercially available products. The number of approved veterinary products is limited, making animals a patient population with suboptimal medicinal treatments available. To answer to this unmet need, compounding and off-label use of human-marketed products are practiced. Both of which have a significant risk of preparation errors. Hence, there is a dire demand to find and implement a more automated approach to the accurate, precise, and rapid production of veterinary dosage forms close to the point-of-care. This study aimed to assess the use of semi-solid extrusion-based 3D printing for the preparation of tailored doses of theophylline in the form of a chewable dosage form suitable for veterinary use. This study proved that semi-solid extrusion-based 3D printing could successfully be utilized to manufacture pet-friendly, chewable theophylline-loaded tablets. The prepared dosage forms showed a high correlation (R = 0.9973) between the designed size and obtained drug amount and met the USP and Ph. Eur. content uniformity criteria. Furthermore, the stability study showed the dosage form being stable and able to be used for up to three months after printing.
由于缺乏市售产品,某些患者群体得不到充分的药物治疗。获批的兽用产品数量有限,这使得动物成为药物治疗欠佳的患者群体。为满足这一未被满足的需求,人们采用了配制和使用人用产品的超适应症用法。这两种方法都存在制备错误的重大风险。因此,迫切需要找到并实施一种更自动化的方法,以便在接近护理点的地方准确、精确且快速地生产兽用剂型。本研究旨在评估基于半固体挤出的3D打印技术在制备适合兽用的可咀嚼剂型的定制剂量茶碱方面的应用。该研究证明,基于半固体挤出的3D打印技术可成功用于制造对宠物友好的、含茶碱的可咀嚼片剂。所制备的剂型在设计尺寸与获得的药物量之间显示出高度相关性(R = 0.9973),并符合美国药典和欧洲药典的含量均匀度标准。此外,稳定性研究表明该剂型稳定,打印后可使用长达三个月。