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Challenges and opportunities in the design of age-appropriate drug products

Herausforderungen und Chancen in der Gestaltung altersgerechter Arzneimittel

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Abstract

The age appropriateness of a pharmaceutical product for older patient populations is most important in achieving ease of use, administration, and adherence as well as the therapeutic benefit of the drug. Drug development is a lengthy and risky investment accompanied by extensive regulatory requirements to meet all the safety, efficacy, and quality criteria of a pharmaceutical product. Older adults represent a very heterogeneous patient population with different needs compared to younger adults. Major areas that should be considered in the design of age-appropriate products (AAP) are age- and disease-related aspects such as (a) different dose strengths, (b) issues in handling, administering, and managing the drug product, (c) and complex medication regimens. The application of different technologies can meet these specific needs and should be considered at the very beginning of product development when setting the targeted quality product profile (TQPP) or later on during the product life-cycle management.

Zusammenfassung

Der einfache Gebrauch und Anwendung von Arzneimitteln ist eine Grundvoraussetzung für Adhärenz und das Erreichen der therapeutischen Ziele. Die altersgerechte Gestaltung von Arzneimitteln spielt dabei für ältere Menschen eine entscheidende Rolle. Die Entwicklung von Arzneimitteln ist eine langfristige und risikoreiche Investition, die begleitet wird von regulatorischen Vorgaben, um die Sicherheit, Wirksamkeit und Qualität des Arzneimittels zu belegen. Ältere Patienten stellen ein sehr heterogenes Patientenkollektiv dar, deren Bedürfnisse sich von denen jüngerer Menschen unterscheiden. Altersgerechte Arzneimittel berücksichtigen die alters- und krankheitsbedingten Veränderungen wie Dosierungen, Probleme der Applikation und Umgang mit Arzneimitteln auch in komplexen therapeutischen Schemata. Durch die Anwendung verschiedener pharmazeutischer Technologien kann diesen Aspekten entsprechend Rechnung getragen werden. Altersgerechte Arzneimittel sollten deshalb bereits am Anfang der Entwicklung im Targeted Quality Product Profile (TQPP) berücksichtigt oder im Zuge des Life Cycle Managements eingeführt werden.

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  1. Capsugel, Rijksweg 11, 2880, Bornem, Belgium

    S. Stegemann

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Stegemann, S. Challenges and opportunities in the design of age-appropriate drug products. Z Gerontol Geriat 45, 479–484 (2012). https://doi.org/10.1007/s00391-012-0361-z

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