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 200 μg budesonide plus 6 μg formoterol Turbuhaler®. To isolate each inhalation parameter some profiles were modified to provide a further 9 profiles to study the influence of Vin and 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 Vin had 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.
| Original language | English |
|---|---|
| Pages (from-to) | 137-146 |
| Number of pages | 10 |
| Journal | International Journal of Pharmaceutics |
| Volume | 522 |
| Issue number | 1-2 |
| DOIs | |
| Publication status | Published - 30 Apr 2017 |
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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®. / Bagherisadeghi, Golshan; Larhrib, El Hassane; Chrystyn, Henry.
In: International Journal of Pharmaceutics, Vol. 522, No. 1-2, 30.04.2017, p. 137-146.Research output: Contribution to journal › Article
TY - JOUR
T1 - 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®
AU - Bagherisadeghi, Golshan
AU - Larhrib, El Hassane
AU - Chrystyn, Henry
PY - 2017/4/30
Y1 - 2017/4/30
N2 - 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 200 μg budesonide plus 6 μg formoterol Turbuhaler®. To isolate each inhalation parameter some profiles were modified to provide a further 9 profiles to study the influence of Vin and 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 Vin had 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.
AB - 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 200 μg budesonide plus 6 μg formoterol Turbuhaler®. To isolate each inhalation parameter some profiles were modified to provide a further 9 profiles to study the influence of Vin and 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 Vin had 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.
KW - Fine particle dose
KW - Inhalation profiles
KW - Mass median aerodynamic diameter
KW - Peak inhalation flow
KW - Total emitted dose
KW - Turbuhaler
UR - http://www.scopus.com/inward/record.url?scp=85015630452&partnerID=8YFLogxK
U2 - 10.1016/j.ijpharm.2017.02.057
DO - 10.1016/j.ijpharm.2017.02.057
M3 - Article
C2 - 28254655
AN - SCOPUS:85015630452
VL - 522
SP - 137
EP - 146
JO - International Journal of Pharmaceutics
JF - International Journal of Pharmaceutics
SN - 0378-5173
IS - 1-2
ER -