TY - JOUR
T1 - Gaining an insight into the importance of each inhalation manoeuvre parameter using altered patients’ inhalation profiles
AU - Abadelah, Mohamad
AU - Abdalla, Gaballa
AU - Chrystyn, Henry
AU - Larhrib, Hassan
N1 - Funding Information:
Henry Chrystyn has no shares in any pharmaceutical companies. He has received sponsorship to carry out studies, together with Board Membership, consultant agreements and honoraria for presentation, from several pharmaceutical companies that market inhaled products. These include Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Innovata Biomed, Meda, Napp.Pharmaceuticals, Mundipharma, NorPharma, Norvartis, Orion, Sanofi, Teva, Truddell Medical International, UCB and Zentiva. Research sponsorship has also been received from grant awarding bodies ( EPSRC and MRC ). He is the owner of Inhalation Consultancy Ltd. He is also a consultant of Research in Real Life, which is subcontracted by Observational and Pragmatic Research Institute Pte Ltd.
Publisher Copyright:
© 2020
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/2/1
Y1 - 2021/2/1
N2 - The aerodynamic particle size distribution (APSD) and dose emission characteristics of indacaterol Breezhaler have been measured using ex-vivo methodology and altering original COPD inhalation manoeuvre profiles to investigate the influence of inspiratory parameters namely, the peak inhalation flow (PIF), inhalation acceleration rate (ACIM) and inhaled volume (Vin) by keeping two parameters fixed and varying the other one. All inhalation parameters had an impact on the dose emission, dose emptying from the capsule/device in the order of PIF > Vin > ACIM. ACIM and Vin have almost an equal effect on the delivered dose (DD) and the fine particle dose (FPD) but the impact of the PIF was the most pronounced. PIF also had the greatest impact on the mass median aerodynamic diameter (MMAD). Producing an optimal inhalation manoeuvre combining the highest PIF, ACIM and Vin in one single inhalation would improve both the quantity and the quality of the aerosol. Making two separate inhalation from each prepared dose would also be useful. This ex-vivo methodology replaying altered COPD profiles with the breath simulator allows an insight on the importance of each inhalation manoeuvre parameter which would have not been possible using conventional in-vitro Pharmacopoeial methodology.
AB - The aerodynamic particle size distribution (APSD) and dose emission characteristics of indacaterol Breezhaler have been measured using ex-vivo methodology and altering original COPD inhalation manoeuvre profiles to investigate the influence of inspiratory parameters namely, the peak inhalation flow (PIF), inhalation acceleration rate (ACIM) and inhaled volume (Vin) by keeping two parameters fixed and varying the other one. All inhalation parameters had an impact on the dose emission, dose emptying from the capsule/device in the order of PIF > Vin > ACIM. ACIM and Vin have almost an equal effect on the delivered dose (DD) and the fine particle dose (FPD) but the impact of the PIF was the most pronounced. PIF also had the greatest impact on the mass median aerodynamic diameter (MMAD). Producing an optimal inhalation manoeuvre combining the highest PIF, ACIM and Vin in one single inhalation would improve both the quantity and the quality of the aerosol. Making two separate inhalation from each prepared dose would also be useful. This ex-vivo methodology replaying altered COPD profiles with the breath simulator allows an insight on the importance of each inhalation manoeuvre parameter which would have not been possible using conventional in-vitro Pharmacopoeial methodology.
KW - Andersen cascade impactor (ACI)
KW - Peak inhalation flow (PIF)
KW - Inhalation volume (Vin)
KW - Acceleration rate (ACIM)
KW - Breath simulator (BRS)
KW - Onbrez Breezhaler®
KW - Inhalation volume (vin)
KW - Breath simulator (BRS) and onbrez Breezhaler®
UR - http://www.scopus.com/inward/record.url?scp=85096384469&partnerID=8YFLogxK
U2 - 10.1016/j.jddst.2020.102181
DO - 10.1016/j.jddst.2020.102181
M3 - Article
VL - 61
JO - Journal of Drug Delivery Science and Technology
JF - Journal of Drug Delivery Science and Technology
SN - 1773-2247
M1 - 102181
ER -
