In vitro Evaluation of Dry Powder Inhaler Devices of Corticosteroid Preparations

Abstract

Background: Although investigations of the drug aerosols generated from inhaled corticosteroid (ICS) preparations and combined drug preparations provide basic information about inhalation therapy, many clinicians have one-sided data about the precision of drug aerosols from the manufacturer. The present study was conducted to analyze and compare the performances of dry powder inhaler (DPI) devices of ICS and combined drug preparations. Methods: The particle size of individual aerosols was measured according to the time-of-flight principle in terms of their aerodynamic diameter by using the aerodynamic particle sizer spectrometer Model 3321. Percent aerosolization was measured using only stage #0 and backup filters of the Andersen non-viable sampler model AN-200. Results: The particle size distribution of aerosols generated from a Turbuhaler™ and Twisthaler™ showed a mono-modal distribution of less than 5 ^m. In contrast, Diskus™ showed a polydisperse distribution, ranging from 0.5 to 20 ^m. The percentages of DPI preparations converted into aerosols with a particle size less than 11 ^m at a suction flow rate of 28.3 L/min were 5.7-6.2% for Diskus, 37.5-47.0% for Turbuhaler, and 19.8% for Twisthaler. At a suction flow rate of 60 L/min, the conversion percentages for DPI preparations into aerosols with a particle size less than 7.6 ^m were 5.9-7.5%, 78.2-86.7%, and 43.5%, respectively. Conclusions: Because in vitro differences in the aerosolization among different DPI devices containing ICS and combined drug preparations were observed, prescribers of these preparations should consider whether the patients will benefit more from the treatment of the central airways versus the peripheral airways.

Keywords

• aerosolization
• devices
• dry powder inhaler (DPI)
• inhaled corticosteroid (ICS)
• particle size