title: Real life dose emission characterization using COPD patient inhalation profiles when they inhaled using a fixed dose combination (FDC) of the medium strength Symbicort®Turbuhaler®.
abstract: The dose emitted from dry powder inhalers (DPI) is inhalation flow dependent and so varies with the peak inhalation flow (PIF) of a patient's inhalation maneuver (IM). Dose emission could also be affected by other IM parameters-the inhaled volume (Vin) and the initial acceleration rate of the IM (ACIM). We have adapted the compendial method for in-vitro DPI determinations so that inhalation profiles replace the inhalation square profile generated by a vacuum pump. These real-life patient inhalation profiles were measured when 18 COPD patients inhaled through an empty placebo Symbicort®Turbuhaler®. They have been used to identify the dose emission characteristics from a fixed dosed combination of 200μg budesonide plus 6μg formoterol Turbuhaler®. To isolate each inhalation parameter some profiles were modified to provide a further 9 profiles to study the influence of Vinand 27 to identify the effect of ACIM. The fine particle dose, total emitted dose and mass median aerodynamic diameter were significantly (p<0.05) influenced by PIF (p<0.05) whereas ACIM and Vinhad only a small effect. The results show the value of this ex-vivo methodology to provide an insight into the dose that each patient would have inhaled during real-life use.
authors.affiliation: Department of Pharmacy, University of Huddersfield, Queensgate, Huddersfield, HD1 3DH, UK.
authors.forename: Golshan
authors.initials: G
authors.lastname: Bagherisadeghi
authors.affiliation: Department of Pharmacy, University of Huddersfield, Queensgate, Huddersfield, HD1 3DH, UK. Electronic address: e.Larhrib@hud.ac.uk.
authors.forename: El Hassane
authors.initials: EH
authors.lastname: Larhrib
authors.affiliation: Inhalation Consultancy Ltd, Tarn House, 77 High Street, Yeadon, Leeds, LS19 7SP, UK.
authors.forename: Henry
authors.initials: H
authors.lastname: Chrystyn
mesh_terms: D000280:Administration, Inhalation; D000336:Aerosols; D000368:Aged; D000465:Algorithms; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D000069502:Budesonide, Formoterol Fumarate Drug Combination / Q000008:administration & dosage* / Q000627:therapeutic use*; D004338:Drug Combinations; D058995:Dry Powder Inhalers; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010316:Particle Size; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology*
chemical_list: D000336:Aerosols; D001993:Bronchodilator Agents; D000069502:Budesonide, Formoterol Fumarate Drug Combination; D004338:Drug Combinations
keywords: Fine particle dose; Inhalation profiles; Mass median aerodynamic diameter; Peak inhalation flow; Total emitted dose; Turbuhaler(®)