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儿科巧克力剂型的质量控制评价:3D 打印与模铸法。

Quality control evaluation of paediatric chocolate-based dosage forms: 3D printing vs mold-casting method.

机构信息

Department of Pharmacy, Division of Pharmaceutical Technology, Faculty of Health Sciences, Aristotle University of Thessaloniki 54124, Greece.

Department of Pharmacy, Division of Pharmaceutical Technology, Faculty of Health Sciences, Aristotle University of Thessaloniki 54124, Greece.

出版信息

Int J Pharm. 2022 Aug 25;624:121991. doi: 10.1016/j.ijpharm.2022.121991. Epub 2022 Jul 7.

DOI:10.1016/j.ijpharm.2022.121991
PMID:35809833
Abstract

Pharmaceutical compounding is a core activity in the preparation of patient-specific dosage forms. In the current study we aimed to investigate whether 3D printing could be employed for the preparation of pediatric-friendly personalized dosage forms that fulfil the acceptance criteria specified in the pharmacopoeias for conventional dosage forms. We then compared the 3D printed dosage forms with the same formulations prepared with mold-casting, a method frequently applied during pharmaceutical compounding. The molded dosage forms failed to pass most of the quality control tests, including the mass uniformity and content uniformity tests, as well as dose accuracy, contrary to the 3D printed, which not only passed all tests but also enabled precision overdose adjustment. Hence, 3D printing of chocolate-based dosage forms may effectively serve as an acceptable alternative method to mold casting in compounding patient-specific medication at the point-of-care.

摘要

药物配制是制备患者专用剂型的核心活动。在本研究中,我们旨在探讨 3D 打印是否可用于制备符合药典中常规剂型规定的可接受标准的儿科友好型个性化剂型。然后,我们将 3D 打印的剂型与通过模铸制备的相同配方的剂型进行了比较,模铸是药物配制中经常使用的一种方法。与 3D 打印的剂型相反,模铸的剂型未能通过大多数质量控制测试,包括质量均匀性和含量均匀性测试以及剂量准确性测试,而 3D 打印的剂型不仅通过了所有测试,还能够进行精确的过量调整。因此,巧克力基剂型的 3D 打印可有效作为在床边配制患者专用药物时替代模铸的可接受方法。

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