In vitro comparison of dose accuracy of two budesonide/formoterol dry powder inhalers
Jussi Haikarainen (Espoo, Finland), Jussi Haikarainen, Anita Happonen, Tero Löytänä
Source: International Congress 2015 – New data on established treatments for asthma, COPD and bronchiectasis
Disease area: Airway diseases
Abstract Background To obtain the desired clinical effect consistently it is essential that dry powder inhalers (DPIs) perform reliably.Aim To compare in vitro dose accuracy of two budesonide/formoterol fumarate dihydrate (formoterol) 160/4.5 µg per inhalation DPIs, Bufomix Easyhaler® (Orion, Finland) and Symbicort® Turbuhaler® (AstraZeneca, UK).Method Dose deliveries were measured using flow rates achievable by the target patient population, asthmatic and COPD patients. The minimum (10th ), median (50th ) and maximum (90th percentile) flow rates were applied as instructed in the guidance (CPMP/EWP/4151/00 Rev1). 36 inhalers representing 2 batches of both products were measured. 10 doses were analysed: 3 from the beginning, 4 from the middle and 3 from the end of labelled number of doses.Results The dose accuracy of the inhalers for budesonide and formoterol are illustrated in the Figure 1. The differences in dose accuracy at the three different flow rates were statistically significant. The variability of delivered dose from Easyhaler is statistically significantly smaller than from Turbuhaler (p<0.001). Figure 1. Budesonide and formoterol delivered dose results from 160/4.5µg per inhalation Bufomix Easyhaler® and Symbicort® Turbuhaler® DPIs applying air flows of 10th , 50th and 90th percentiles target patient populations.Conclusion The Bufomix Easyhaler® dose accuracy is significantly better than Symbicort® Turbuhaler®.
Rating:
You must login to grade this presentation.
Share or cite this content
Citations should be made in the following way:
Jussi Haikarainen (Espoo, Finland), Jussi Haikarainen, Anita Happonen, Tero Löytänä. In vitro comparison of dose accuracy of two budesonide/formoterol dry powder inhalers. Eur Respir J 2015; 46: Suppl. 59, 2953
You must login to share this Presentation/Article on Twitter, Facebook, LinkedIn or by email.
Member's Comments
Related content which might interest you:
Related content which might interest you:
Impact of critical handling errors on delivered budesonide/formoterol dose in dry powder inhalers – An in vitro study Source: International Congress 2016 – Pulmonary drug delivery Year: 2016
Once-daily budesonide: clinical equivalence of two dry powder inhalers (DPIs) Source: Eur Respir J 2005; 26: Suppl. 49, 339s Year: 2005
Aerodynamic characteristics of dry powder inhaler (DPI) single-dose combination of budesonide with formoterol in vitro study validation Source: Annual Congress 2012 - The best of pharmacology treatments of airway diseases: new devices and drugs Year: 2012
Clinical equivalence of budesonide delivered via two dry powder inhalers Source: Eur Respir J 2005; 26: Suppl. 49, 339s Year: 2005
A study to evaluate the therapeutic equivalence of a new multidose budesonide dry powder inhaler with a conventional budesonide dry powder inhaler Source: Eur Respir J 2001; 18: Suppl. 33, 156s Year: 2001
Pharmaceutical performances of formoterol delivered from a novel multidose dry powder inhaler Source: Eur Respir J 2001; 18: Suppl. 33, 134s Year: 2001
Efficacy and safety of salbutamol delivered via a novel multidose dry powder inhaler in comparison with two conventional dry powder inhalers and a pMDI in asthmatic subjects Source: Eur Respir J 2001; 18: Suppl. 33, 50s Year: 2001
Ex-vivo emitted dose characteristics for combination formulations in dry powder inhalers (DPI) Source: Eur Respir J 2003; 22: Suppl. 45, 472s Year: 2003
Formoterol: a new pMDI CFC free formulation. cumulative dose safety versus a dry powder Source: Eur Respir J 2003; 22: Suppl. 45, 473s Year: 2003
Comparative in vitro performance of the new drug aclidinium in a novel multidose dry powder inhaler Source: Annual Congress 2013 –New clinical trials of asthma and COPD drugs Year: 2013
In vitro validation of the use of a spacer with an extrafine beclomethasone/formoterol formulation Source: International Congress 2016 – Pulmonary drug delivery Year: 2016
Do asthma patients achieve effective dosing from dry powder inhalers (DPIs)? Source: Eur Respir J 2005; 26: Suppl. 49, 338s Year: 2005
Formoterol: a new pMDI CFC free formulation. Efficacy of the 12µg dosage versus a dry powder inhaler in moderate to severe asthmatic patients Source: Eur Respir J 2003; 22: Suppl. 45, 284s Year: 2003
Equivalence testing of salbutamol dry powder inhalers by in vitro impaction Source: Eur Respir J 2001; 18: Suppl. 33, 100s Year: 2001
In vitro testing of two budesonide dry powder inhalers at different flow ratesSource: Eur Respir J 2001; 18: Suppl. 33, 101s Year: 2001
Comparison of a formoterol multiple dose dry powder inhaler (MDPI) with a formoterol single dose dry powder inhaler (SDPI) in patients with moderate to severe asthma Source: Eur Respir J 2004; 24: Suppl. 48, 260s Year: 2004
Use of a new dry powder inhaler to deliver umeclidinium/vilanterol in the treatment of COPD Source: Annual Congress 2013 –COPD drugs: new findings Year: 2013
Bronchodilator effect of formoterol delivered by two different dry powder inhalers (DPI) Source: Eur Respir J 2004; 24: Suppl. 48, 310s Year: 2004
Pharmacokinetic studies for the estimation of bioequivalence of two DPIs containing budesonide and formoterol Source: International Congress 2015 – New data on established treatments for asthma, COPD and bronchiectasis Year: 2015
Equivalence of an innovative multidose salmeterol/fluticasone dry powder inhaler vs comparator in paediatric asthma Source: Annual Congress 2013 –Asthma treatment and management in children Year: 2013