Heinrich Heine University Düsseldorf, Institute of Pharmaceutics and Biopharmaceutics, Universitätsstr. 1, 40225 Düsseldorf, Germany.
Int J Pharm. 2019 Apr 20;561:314-323. doi: 10.1016/j.ijpharm.2019.03.019. Epub 2019 Mar 13.
Individualized medicine is relevant to ensure safe and efficient pharmacotherapy. It requires a suitable dosage form and a matching dosing device to enable flexible dosing serving the needs of individual dose requirements. For oral films no flexible dosing option is available until today. This study covers the development of a dosing device that enables flexible dosing of films within the pharmacopoeial requirements. The prototype was produced with the 3D-printing technique fused filament fabrication. The developed and produced prototype of the device was tested for the uniformity of doses according to Ph.Eur. 2.9.27 and 2.9.40. A ribbon as model film and an oral film with HPMC as polymer matrix met the specifications for both tests for three different lengths dispensed with the prototype of the dosing device (HPMC film: AV = 11.30 (1 cm), 12.04 (2 cm) and 10.19 (5 cm)). A second oral film with a polymer matrix from PVA and HPMC exceeded the threshold for the shortest piece of 1 cm (AV = 26.54) because of slight splintering during the cutting process, likely due to too little plasticizer in the formulation. A successful device development and a use within the specifications of the European Pharmacopoeia is demonstrated.
个体化医学对于确保安全有效的药物治疗至关重要。它需要合适的剂型和匹配的给药装置，以实现灵活的剂量调整，满足个体剂量需求。迄今为止，口服薄膜剂还没有灵活的剂量调整选择。本研究涵盖了开发一种给药装置的工作，该装置能够根据药典要求灵活调整薄膜剂的剂量。该原型是使用 3D 打印技术熔融丝制造生产的。根据欧洲药典 2.9.27 和 2.9.40，对设备的开发和生产原型进行了剂量均匀性测试。一条作为模型薄膜的带状物和一种以 HPMC 为聚合物基质的口服薄膜，满足了这两种测试的规格要求，这两种测试使用了该剂量给药装置的原型（HPMC 薄膜：AV=11.30（1cm）、12.04（2cm）和 10.19（5cm））。第二种以 PVA 和 HPMC 为聚合物基质的口服薄膜，由于在切割过程中出现轻微的碎片，导致最短 1cm 长度的片超出了阈值（AV=26.54），这可能是由于配方中增塑剂太少。成功开发了一种给药装置，并在欧洲药典的规范内使用。
