Spacer, Aerosoltherapie durch Raum und Zeit

Zusammenfassung

Ziel der Literaturübersicht In diesem Review werden die Ergebnisse einer Literaturanalyse zur Anwendung von Spacern mit Dosieraerosolen beschrieben und bewertet.

Methodik Neben einer umfangreichen Aufarbeitung der Spacereffekte werden die Auswirkungen aktueller Leitlinien und Rahmenbedingungen für Produktzulassungen auf die Spaceranwendung beschrieben, die sich aus der Interaktion der Eigenschaften von Dosieraerosolen mit einem Spacer ergeben.

Ergebnisse Zur Vermeidung von Koordinationsproblemen bei der Auslösung eines Dosieraerosols zu Beginn der Einatmung sind Spacer generell sinnvoll. Für alle Dosieraerosol-Spacer-Kombinationen gilt zudem, dass die Mund-Rachen-Deposition im Vergleich zur Dosieraerosolanwendung ohne Spacer reduziert wird. Einige neuere Dosieraerosole setzen allerdings das Aerosol in einer Qualität frei, die einen Spacer zur Vermeidung einer hohen Wirkstoffdeposition im Mund-Rachen-Raum nicht zwingend erforderlich macht, weil die Aerosolqualität über einen Spacer nicht mehr wesentlich verbessert werden kann. Die aus einem Spacer freigesetzte Wirkstoffmasse und die Aerosolqualität variieren aber erheblich bei Verwendung unterschiedlicher Spacer. Ein Spacerwechsel kann bei Verwendung des gleichen Dosieraerosols maximal zu einer Verdopplung oder Halbierung der applizierten Wirkstoffmenge führen. Diese Fakten werden inzwischen von der europäischen Zulassungsbehörde berücksichtigt.

Schlussfolgerung Die Fachinformationen der Dosieraerosole, die nach 2009 entwickelt und zugelassen wurden, sollten, sofern eine Spaceranwendung vorgesehen ist, mindestens eine konkrete Spacerempfehlung aussprechen, die auf entsprechenden In-vitro-Daten bzw. ergänzenden In-vivo-Daten beruht. Wird ein anderer Spacer als der empfohlene mit diesem Dosieraerosol eingesetzt, ist es nicht möglich, die applizierte Dosis vorherzusehen. Dies sollte bei der Spacerauswahl berücksichtigt werden.

Abstract

Aim of the literature review Within this review, results of a literature analysis on the application of spacers with pressurized metered dose inhalers (pMDI) are described and evaluated.

Methods Next to an extensive revision on effects of spacers, the impacts of current guidelines and the conditions for product authorisations on the use of spacers are described which result from the interplay of characteristics from dose inhalers with a spacer.

Results Spacers are generally useful to avoid coordination problems concerning the actuation of a pMDI at the beginning of an inhalation. Furthermore, in comparison to the pMDI application without a spacer a reduced mouth-throat deposition is applicable to all pMDI spacer combinations. However, some new pMDI release the aerosol in a quality that may not necessarily require a spacer to avoid a high drug deposition in the mouth-throat area as the aerosol quality will not be greatly improved with a spacer. The delivered mass of the active ingredient as well as the aerosol quality released from a spacer vary substantially with the use of different spacers. A change of spacer while using the same dose inhaler can maximally result in a doubling or halving of the quantity of the active ingredient applied. These facts are nowadays considered by the European regulatory agency.

Conclusion If a spacer application is intended for pMDIs that were developed and approved after 2009, the correspondent SMP (Summary of Product Characteristics) should at least make one specific recommendation for a spacer that should be based upon relevant in vitro data or additional in vivo data. If a different spacer than the recommended one is used, the effectively applied dose cannot be correctly anticipated. This should be considered when choosing a spacer.

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