Aerosolcharakteristika ausgewählter Druckluftvernebler für Erwachsene in Simulationsmodellen und Verneblung von Salbutamol^[*]

Zusammenfassung

Ziel Der Erfolg einer Inhalationstherapie wird durch Menge und Qualität des inhalierten Aerosols bestimmt. Die Auswahl eines Verneblers bedarf der Kenntnis der entsprechenden Aerosolcharakteristika.

Methoden Die Aerosolperformance von 9 marktüblichen Druckluftverneblern wurde in vitro in 2 Simulationsmodellen geprüft. Salbutamol (Sultanol forte^® Fertiginhalat 2,5 mg/2,5 ml; GSK) wurde über 4 Minuten vernebelt. Die Outputparameter wurden mit dem Atemzugsimulator PARI Compas II (Erwachsenenmanöver nach Ph.Eur.9.0; n = 5/6 Verneblungen) und die aerodynamische Partikelgrößenverteilung mit dem Next Generation Impaktor (Ph.Eur.9.0, Copley Scientific; n = 3 Verneblungen) per HPLC bestimmt.

Ergebnisse Die Vernebler generierten deutlich unterschiedliche Abgaberaten und Aerosolspektren. Die Drug Delivery Rate (DDR) variierte zwischen 196 µg/min (PARI LC Sprint (blau)) und 67 µg/min (MIDINEB). Die aus DDR und Feinpartikelanteil ≤ 5 µm berechnete intrapulmonal deponierte Aerosolmenge (Respirable Drug Delivery Rate, RDDR) variierte um den Faktor 3,5.

Schlussfolgerungen Die Ergebnisse der In-vitro-Untersuchungen können unterstützend zur Auswahl eines geeigneten Druckluftverneblers genutzt werden. Für eine effektive Therapie und gute Compliance sollte ein Vernebler mit einer hohen RDDR gewählt werden.

Abstract

Aim Successful inhalation therapy with nebulisers depends on the amount and quality of the aerosol. Choosing a nebuliser requires knowledge of relevant aerosol characteristics.

Methods We analysed the aerosol performance of 9 commercially available jet nebulisers in 2 in vitro simulation models by assessing the aerosol delivery of albuterol (Sultanol forte^® Inhalation Solution 2.5 mg/2.5 ml; GSK) over 4 minutes. The output parameters were analysed with PARI Compas II breath simulator mimicking an adult breathing pattern (Ph.Eur.9.0; n = 5/6 nebulisation), and the aerodynamic particle size distribution was determined by the Next Generation Impactor (Ph.Eur.9.0, Copley Scientific; n = 3 nebulisation).

Results The aerosol performance of the devices differed considerably. The DDR varied from 196 µg/min (PARI LC Sprint (blue)) to 67 µg/min (MIDINEB). The Respirable Drug Delivery Rate (RDDR), calculated from the DDR and the Fine Particle Fraction ≤ 5 µm, varied by a factor of 3.5 between the nebulisers tested.

Conclusion The results of the in vitro simulation studies can be utilised to select an appropriate nebuliser for the individual patient. In order to enhance therapeutic efficacy and patient compliance, a nebuliser with a high RDDR should be selected.

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