title: Difference in resistance to humidity between commonly used dry powder inhalers: an in vitro study.
abstract: Multi-dose dry powder inhalers (DPIs) are commonly used in asthma and chronic obstructive lung disease (COPD) treatment. A disadvantage is their sensitivity to humidity. In real life, DPIs are periodically exposed to humid conditions, which may affect aerosol characteristics and lung deposition. This study compared DPI aerosol performance after exposure to humidity. Budesonide (BUD) inhalers (Turbuhaler; Novolizer; Easyhaler) and budesonide/formoterol (BUD/FORM) inhalers (Turbuhaler; Spiromax; Easyhaler) were stored in 75% relative humidity (RH) at both ambient temperature and at -0 °C. Delivered dose (DD) and fine-particle dose (FPD) were tested in vitro before and after storage. BUD inhalers: Turbuhaler and Novolizer showed only small decreases (<15%) in FPD in 40 °C/75% RH, whereas FPD for Easyhaler decreased by >60% (P=0.01) after 1.5 months of storage. Easyhaler also decreased significantly after 6 months of storage in ambient/75%RH by 25% and 54% for DD and FPD, respectively, whereas only small decreases were seen for Turbuhaler and Novolizer (<15%). BUD/FORM inhalers: Turbuhaler and Spiromax DD were unchanged in 40 °C/75% RH, whereas Easyhaler showed a small decrease. FPD (budesonide) decreased for Turbuhaler, Spiromax and Easyhaler by 18%, 10% and 68% (all significant), respectively, at 40 °C/75% RH. In ambient/75%RH, DD was unchanged for all inhalers, whereas FPD (budesonide) decreased for Spiromax (7%, P=0.02) and Easyhaler (34%, (P<0.01)). There are significant differences in device performance after exposure to humid conditions. A clinically relevant decrease of more than half FPD was seen for one of the inhalers, a decrease that may affect patients' clinical outcomes. Prescriber and patient knowledge on device attributes are essential to ensure optimal drug delivery to the lungs.
authors.affiliation: Department of Medical Sciences: Respiratory, Allergy and Sleep Research, Uppsala University, Uppsala, Sweden.
authors.forename: Christer
authors.initials: C
authors.lastname: Janson
authors.affiliation: AstraZeneca R&D, Mölndal, Sweden.
authors.forename: Thomas
authors.initials: T
authors.lastname: Lööf
authors.affiliation: AstraZeneca Nordic-Baltic, Södertälje, Sweden.
authors.forename: Gunilla
authors.initials: G
authors.lastname: Telg
authors.affiliation: Department of Medical Sciences: Respiratory, Allergy and Sleep Research, Uppsala University, Uppsala, Sweden.|AstraZeneca Nordic-Baltic, Södertälje, Sweden.
authors.forename: Georgios
authors.initials: G
authors.lastname: Stratelis
authors.affiliation: Närhälsan Primary care, Kungshamn, Sweden.
authors.forename: Folke
authors.initials: F
authors.lastname: Nilsson
mesh_terms: D000280:Administration, Inhalation; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy; D019819:Budesonide / Q000008:administration & dosage*; D000069502:Budesonide, Formoterol Fumarate Drug Combination / Q000008:administration & dosage*; D058995:Dry Powder Inhalers; D006801:Humans; D006813:Humidity; D066298:In Vitro Techniques; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy
chemical_list: D018927:Anti-Asthmatic Agents; D000069502:Budesonide, Formoterol Fumarate Drug Combination; D019819:Budesonide