Experimental and computational study of the effect of breath-actuated mechanism built in the NEXThaler® dry powder inhaler
[Display omitted] The breath-actuated mechanism (BAM) is a mechanical unit included in NEXThaler® with the role of delaying the emission of the drug until the inhalation flow rate of the patient is sufficiently high to detach the drug particles from their carriers. The main objective of this work wa...
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Published in | International journal of pharmaceutics Vol. 533; no. 1; pp. 225 - 235 |
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Main Authors | , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Netherlands
Elsevier B.V
25.11.2017
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Subjects | |
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Abstract | [Display omitted]
The breath-actuated mechanism (BAM) is a mechanical unit included in NEXThaler® with the role of delaying the emission of the drug until the inhalation flow rate of the patient is sufficiently high to detach the drug particles from their carriers.
The main objective of this work was to analyse the effect of the presence of BAM on the size distribution of the emitted drug and its airway deposition efficiency and distribution. Study of the hygroscopic growth of the emitted drug particles and its effect on the deposition was another goal of this study.
Size distributions of Foster® NEXThaler® drug particles emitted by dry powder inhalers with and without BAM have been measured by a Next Generation Impactor. Three characteristic inhalation profiles of asthmatic patients (low, moderate and high flow rates) were used for both experimental and modelling purposes. Particle hygroscopic growth was determined by a new method, where experimental measurements are combined with simulations. Upper airway and lung deposition fractions were computed assuming 5s and 10s breath-hold times.
By the inclusion of BAM the fine particle fraction of the steroid component increased from 24 to 30% to 47–51%, while that of bronchodilator from 25–34% to 52–55%. The predicted upper airway steroid and bronchodilator doses decreased from about 60% to 35–40% due to BAM. At the same time, predicted lung doses increased from about 20%–35% (steroid) and from 22% to 38% (bronchodilator) for the moderate flow profile and from about 25% to 40% (steroid) and from 29% to 47% (bronchodilator) for the high inhalation flow profile. Although BDP and FF upper airway doses decreased by a factor of about two when BAM was present, lung doses of both components were about the same in the BAM and no-BAM configurations at the weakest flow profile. However, lung dose increased by 2–3% even for this profile when hygroscopic growth was taken into account.
In conclusion, the NEXThaler® BAM mechanism is a unique feature enabling high emitted fine particle fraction and enhanced drug delivery to the lungs. |
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AbstractList | The breath-actuated mechanism (BAM) is a mechanical unit included in NEXThaler® with the role of delaying the emission of the drug until the inhalation flow rate of the patient is sufficiently high to detach the drug particles from their carriers. The main objective of this work was to analyse the effect of the presence of BAM on the size distribution of the emitted drug and its airway deposition efficiency and distribution. Study of the hygroscopic growth of the emitted drug particles and its effect on the deposition was another goal of this study. Size distributions of Foster® NEXThaler® drug particles emitted by dry powder inhalers with and without BAM have been measured by a Next Generation Impactor. Three characteristic inhalation profiles of asthmatic patients (low, moderate and high flow rates) were used for both experimental and modelling purposes. Particle hygroscopic growth was determined by a new method, where experimental measurements are combined with simulations. Upper airway and lung deposition fractions were computed assuming 5s and 10s breath-hold times. By the inclusion of BAM the fine particle fraction of the steroid component increased from 24 to 30% to 47-51%, while that of bronchodilator from 25-34% to 52-55%. The predicted upper airway steroid and bronchodilator doses decreased from about 60% to 35-40% due to BAM. At the same time, predicted lung doses increased from about 20%-35% (steroid) and from 22% to 38% (bronchodilator) for the moderate flow profile and from about 25% to 40% (steroid) and from 29% to 47% (bronchodilator) for the high inhalation flow profile. Although BDP and FF upper airway doses decreased by a factor of about two when BAM was present, lung doses of both components were about the same in the BAM and no-BAM configurations at the weakest flow profile. However, lung dose increased by 2-3% even for this profile when hygroscopic growth was taken into account. In conclusion, the NEXThaler® BAM mechanism is a unique feature enabling high emitted fine particle fraction and enhanced drug delivery to the lungs. The breath-actuated mechanism (BAM) is a mechanical unit included in NEXThaler with the role of delaying the emission of the drug until the inhalation flow rate of the patient is sufficiently high to detach the drug particles from their carriers. The main objective of this work was to analyse the effect of the presence of BAM on the size distribution of the emitted drug and its airway deposition efficiency and distribution. Study of the hygroscopic growth of the emitted drug particles and its effect on the deposition was another goal of this study. Size distributions of Foster NEXThaler drug particles emitted by dry powder inhalers with and without BAM have been measured by a Next Generation Impactor. Three characteristic inhalation profiles of asthmatic patients (low, moderate and high flow rates) were used for both experimental and modelling purposes. Particle hygroscopic growth was determined by a new method, where experimental measurements are combined with simulations. Upper airway and lung deposition fractions were computed assuming 5s and 10s breath-hold times. By the inclusion of BAM the fine particle fraction of the steroid component increased from 24 to 30% to 47-51%, while that of bronchodilator from 25-34% to 52-55%. The predicted upper airway steroid and bronchodilator doses decreased from about 60% to 35-40% due to BAM. At the same time, predicted lung doses increased from about 20%-35% (steroid) and from 22% to 38% (bronchodilator) for the moderate flow profile and from about 25% to 40% (steroid) and from 29% to 47% (bronchodilator) for the high inhalation flow profile. Although BDP and FF upper airway doses decreased by a factor of about two when BAM was present, lung doses of both components were about the same in the BAM and no-BAM configurations at the weakest flow profile. However, lung dose increased by 2-3% even for this profile when hygroscopic growth was taken into account. In conclusion, the NEXThaler BAM mechanism is a unique feature enabling high emitted fine particle fraction and enhanced drug delivery to the lungs. [Display omitted] The breath-actuated mechanism (BAM) is a mechanical unit included in NEXThaler® with the role of delaying the emission of the drug until the inhalation flow rate of the patient is sufficiently high to detach the drug particles from their carriers. The main objective of this work was to analyse the effect of the presence of BAM on the size distribution of the emitted drug and its airway deposition efficiency and distribution. Study of the hygroscopic growth of the emitted drug particles and its effect on the deposition was another goal of this study. Size distributions of Foster® NEXThaler® drug particles emitted by dry powder inhalers with and without BAM have been measured by a Next Generation Impactor. Three characteristic inhalation profiles of asthmatic patients (low, moderate and high flow rates) were used for both experimental and modelling purposes. Particle hygroscopic growth was determined by a new method, where experimental measurements are combined with simulations. Upper airway and lung deposition fractions were computed assuming 5s and 10s breath-hold times. By the inclusion of BAM the fine particle fraction of the steroid component increased from 24 to 30% to 47–51%, while that of bronchodilator from 25–34% to 52–55%. The predicted upper airway steroid and bronchodilator doses decreased from about 60% to 35–40% due to BAM. At the same time, predicted lung doses increased from about 20%–35% (steroid) and from 22% to 38% (bronchodilator) for the moderate flow profile and from about 25% to 40% (steroid) and from 29% to 47% (bronchodilator) for the high inhalation flow profile. Although BDP and FF upper airway doses decreased by a factor of about two when BAM was present, lung doses of both components were about the same in the BAM and no-BAM configurations at the weakest flow profile. However, lung dose increased by 2–3% even for this profile when hygroscopic growth was taken into account. In conclusion, the NEXThaler® BAM mechanism is a unique feature enabling high emitted fine particle fraction and enhanced drug delivery to the lungs. |
Author | Tweedie, Alan Haddrell, Allen E. Reid, Jonathan P. Mason, Francesca Lewis, David Church, Tanya Balásházy, Imre Horváth, Alpár Farkas, Árpád |
Author_xml | – sequence: 1 givenname: Árpád surname: Farkas fullname: Farkas, Árpád email: farkas.arpad@energia.mta.hu organization: Centre for Energy Research, Hungarian Academy of Sciences, Konkoly-Thege Miklós út 29-33, 1121, Budapest, Hungary – sequence: 2 givenname: David surname: Lewis fullname: Lewis, David organization: Chippenham Research Centre, Chiesi Limited, Chippenham, Wiltshire, SN14 0AB, UK – sequence: 3 givenname: Tanya surname: Church fullname: Church, Tanya organization: Chippenham Research Centre, Chiesi Limited, Chippenham, Wiltshire, SN14 0AB, UK – sequence: 4 givenname: Alan surname: Tweedie fullname: Tweedie, Alan organization: Chippenham Research Centre, Chiesi Limited, Chippenham, Wiltshire, SN14 0AB, UK – sequence: 5 givenname: Francesca surname: Mason fullname: Mason, Francesca organization: Chippenham Research Centre, Chiesi Limited, Chippenham, Wiltshire, SN14 0AB, UK – sequence: 6 givenname: Allen E. surname: Haddrell fullname: Haddrell, Allen E. organization: School of Chemistry, University of Bristol, Bristol, BS8 1TS, UK – sequence: 7 givenname: Jonathan P. surname: Reid fullname: Reid, Jonathan P. organization: School of Chemistry, University of Bristol, Bristol, BS8 1TS, UK – sequence: 8 givenname: Alpár surname: Horváth fullname: Horváth, Alpár organization: Chiesi Hungary Ltd., Dunavirág u. 2, 1138, Budapest, Hungary – sequence: 9 givenname: Imre surname: Balásházy fullname: Balásházy, Imre organization: Centre for Energy Research, Hungarian Academy of Sciences, Konkoly-Thege Miklós út 29-33, 1121, Budapest, Hungary |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/28941830$$D View this record in MEDLINE/PubMed |
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Keywords | DD FF BH SPC Formoterol fumarate Airway deposition modelling p10 BDP CK-EDB LABA Breath-actuated mechanism GF MOC Aerosol drug targeting ACI MMAD ACN PIF BAM Hygroscopic growth NGI PIL Particle size distribution UPLC RH ICS Beclomethasone dipropionate EPF DPI FPF DUSA |
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The breath-actuated mechanism (BAM) is a mechanical unit included in NEXThaler® with the role of delaying the emission of the drug until the... The breath-actuated mechanism (BAM) is a mechanical unit included in NEXThaler with the role of delaying the emission of the drug until the inhalation flow... The breath-actuated mechanism (BAM) is a mechanical unit included in NEXThaler® with the role of delaying the emission of the drug until the inhalation flow... |
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SubjectTerms | Adrenal Cortex Hormones - administration & dosage Adrenal Cortex Hormones - chemistry Aerosol drug targeting Airway deposition modelling Anti-Asthmatic Agents - administration & dosage Anti-Asthmatic Agents - chemistry Asthma - drug therapy Asthma - metabolism Beclomethasone - administration & dosage Beclomethasone - chemistry Beclomethasone dipropionate Breath-actuated mechanism Bronchodilator Agents - administration & dosage Bronchodilator Agents - chemistry Dry Powder Inhalers Formoterol fumarate Formoterol Fumarate - administration & dosage Formoterol Fumarate - chemistry Humans Hygroscopic growth Lung - metabolism Models, Biological Particle Size Particle size distribution Respiration |
Title | Experimental and computational study of the effect of breath-actuated mechanism built in the NEXThaler® dry powder inhaler |
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