Clinical equivalence of budesonide dry powder inhaler and pressurized metered dose inhaler

Abstract

Introduction: A delivery device is the most important factor that determines the local/systemic bioavailability of inhaled corticosteroids. Dry powder inhalers (DPIs) and pressurized metered dose inhalers (pMDIs) are the most commonly used delivery devices for localized drug delivery to the airways. Objective: This study was to compare the clinical equivalence of budesonide delivered by the Pulmicort Turbuhaler TM (DPI) and the Aeronide TM inhaler (pMDI). Materials and Methods: The two inhalers were compared for their pharmaceutical equivalence and clinical equivalence. The in vitro test included the uniformity of the delivered dose and determination of the aerodynamic particle size of budesonide. The in vivo test was carried out in 36 patients with mild to moderate asthma. This was a randomized, single-blinded study conducted for a period of 3 months. This included assessment of the spirometric parameters [forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), peak expiratory flow rate (PEFR), forced expiratory flow 25-75% (FEF25-75)], the severity of asthma symptoms, adverse events, frequency of short-acting inhaled bronchodilator usage and measurement of urinary cortisol levels. Results: The aerodynamic particle size was slightly different between the two inhalers (2.3 ± 0.2 µm for Pulmicort Turbuhaler TM and 2.2 ± 0.2 µm for Aeronide TM inhaler). Both inhalers passed the uniformity of delivered dose (95.4% and 97.4%) specified in the British Pharmacopoeia. There was no statistically significant difference observed between the two inhalers in terms of the spirometric parameters, symptom-free days, frequency of bronchodilator usage and the level of urinary cortisol. Conclusion: In addition to pharmaceutical equivalence, no clinical difference observed between the two budesonide inhalers.Please cite this paper as: Srichana T, Juthong S, Thawithong E, Supaiboonpipat S and Soorapan S. Clinical equivalence of budesonide dry powder inhaler and pressurized metered dose inhaler. Clin Respir J 2014; ••: ••-••.

Deposition Pattern of Polydisperse Dry Powders in Andersen Cascade Impactor - Aerodynamic Assessment for Inhalation Experimentally and <i>In Silico</i>

“…where K e is the particle's kinetic energy Mass p is the mass of the particle in kilograms ν p is the particle's velocity in meters per second Volume of sphhere = 4 πr 3 , Equation 4 3…”

“…1 The Andersen cascade impactor (ACI) is a conventional cascade impactor that has been used in various aerosol studies. [2][3][4] The ACI has been developed to characterize aerodynamic particle size distribution (PSD) and particle deposition, by using an inertial impactor so that the aerodynamic size affects the inertial forces, and different sizes are collected on individual collection plates. 5 The standard ACI has eight stages.…”

Deposition Pattern of Polydisperse Dry Powders in Andersen Cascade Impactor – Aerodynamic Assessment for Inhalation Experimentally and in Silico

“…Even if the impactor does not perfectly represent a realistic respiratory tract, it provides data for comparing formulations and products 1 . The Andersen cascade impactor (ACI) is a conventional cascade impactor that has been used in various aerosol studies [2][3][4] . The ACI has been developed to characterize an aerodynamic particle size distribution and particle deposition, by using inertial impactor so that the aerodynamic size affects the inertial forces, and different sizes are collected on individual collection plate 5 .…”