Mikronadelsysteme und Microarray Patches
Die nächste Generation transdermaler therapeutischer Systeme für Arznei- und Impfstoffe
Originale
Key words Mikronadel/microneedle | Microarray Patch | Intradermale Injektion/intradermal injection
Abstract
Microneedle systems and microarray patches – the next generation of transdermal therapeutic systems for drugs and vaccines
The present article presents on the one hand a summary of both historical and currently used devices of microneedle systems and so-called microarray patches (MAP) as well, on the other hand dosage forms in the development of the LTS Lohmann Therapie-Systeme AG incl. experimental in vitro data experiments and also clinical data. These systems are regarded as the next generation of transdermal therapeutic systems for active pharmaceutical ingredients (API) and vaccines. Inactive ingredients, designs and functionality of the final drug products are described. Furthermore, analytical test methods for the assessment of their efficiency are presented. In the end of the article, an outlook of the currently most promising designs is discussed. Those devices are the high sophisticated so-called „dissolving microneedle systems“, equipped with self-dissolving microneedles made of bio-degradable polymers. Intentionally, regulatory requirements are not discussed, since those requirements do not differ in general from requirements for other dosage forms, which means efficacy, safety and quality throughout the lifecycle safety and quality throughout the lifecycle of the microneedle system must be confirmed by experimental data.
Korrespondenz:
Dr. Stefan Henke, LTS Lohmann Therapie-Systeme AG, Lohmannstraße 2, 56626 Andernach (Germany), E-Mail: Stefan.Henke@ltslohmann.de
Zusammenfassung
Der vorliegende Beitrag präsentiert zum einen eine Zusammenfassung der historischen und aktuell genutzten Ausführungsformen von Mikronadelsystemen und sog. Microarray Patches (MAP) inkl. Anwendungsbeispielen, zum anderen klinische und experimentelle In-vitro-Ergebnisse der LTS Lohmann-Therapie Systeme AG. Diese Systeme gelten als die nächste Generation von Transdermalen Therapeutischen Systemen für Arznei- und Impfstoffe. Der Artikel beschreibt
