Schwarz Nicolle, Enke Marcel, Gruschwitz Franka V, Winkler Daniela, Franzmann Susanne, Jescheck Lisa, Hanf Felix, Schneeberger Achim
Laxxon Medical GmbH, Hans-Knöll-Street 6, 07745 Jena, Germany.
Pharmaceutics. 2024 Mar 5;16(3):368. doi: 10.3390/pharmaceutics16030368.
A threat to human health in developed and, in particular, in developing countries, counterfeit medicines represent the largest identified fraud market worldwide. 3D screen printing (3DSP), an additive manufacturing technology that enables large-scale production, offers unique opportunities to combat counterfeit drugs. One such possibility is the generation of oral dosage forms with a distinct colored inner structure that becomes visible upon breakage and cannot be copied with conventional manufacturing methods. To illustrate this, we designed tablets containing a blue cross. Owing to paste properties and the limited dimensions of the cross, the production process was chosen to be continuous, involving two screen and paste changes. The two pastes (tablet body, cross) were identical except for the blue color of the latter. This ensured the build-up and mechanical stability of the resulting tablets in a mass production environment. The ensuing tablets were found to be uniform in weight and size and to comply with regulatory requirements for hardness, friability, and disintegration time (immediate release). Moreover, all tablets exhibited the covert anticounterfeit feature. The study delivers a proof-of-concept for incorporating complex structures into tablets using 3DSP and showcases the power of the technology offering new avenues for combating counterfeit drugs.
假药对发达国家尤其是发展中国家的人类健康构成威胁，是全球已查明的最大欺诈市场。三维丝网印刷（3DSP）作为一种能够实现大规模生产的增材制造技术，为打击假药提供了独特机遇。其中一种可能性是生产具有独特彩色内部结构的口服剂型，这种结构在片剂破损时可见，且无法用传统制造方法复制。为说明这一点，我们设计了带有蓝色十字的片剂。由于糊剂特性和十字的尺寸限制，生产过程选择为连续式，涉及两次丝网和糊剂更换。除了后者的蓝色外，两种糊剂（片剂主体、十字）完全相同。这确保了在大规模生产环境下所得片剂的成型和机械稳定性。结果发现，后续片剂在重量和尺寸上均匀一致，并且符合硬度、脆碎度和崩解时间（速释）的监管要求。此外，所有片剂都具有隐蔽的防伪特征。该研究为使用3DSP将复杂结构纳入片剂提供了概念验证，并展示了该技术的力量，为打击假药开辟了新途径。
