The effect of inspiratory parameters after two separate inhalations on the dose emission of theophylline from low and high resistance dry powder inhalers

The dose emission from DPIs can be affected by the inspiratory parameters achieved by the patient as well as the device in-use. Conventional in-vitro dose emission methodology was used, but instead of using inhalation volume (Vin) of 2 or 4 L and peak inhalation flow (PIF) corresponding to 4 kPa, a...

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Main Authors: Mohamad Abadelah, Jumannah Al-Assadi, James Rooney, Hassane Larhrib
Format: Article
Language:English
Published: Elsevier 2020-01-01
Series:Saudi Pharmaceutical Journal
Online Access:http://www.sciencedirect.com/science/article/pii/S1319016419301410
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author Mohamad Abadelah
Jumannah Al-Assadi
James Rooney
Hassane Larhrib
author_facet Mohamad Abadelah
Jumannah Al-Assadi
James Rooney
Hassane Larhrib
author_sort Mohamad Abadelah
collection DOAJ
description The dose emission from DPIs can be affected by the inspiratory parameters achieved by the patient as well as the device in-use. Conventional in-vitro dose emission methodology was used, but instead of using inhalation volume (Vin) of 2 or 4 L and peak inhalation flow (PIF) corresponding to 4 kPa, a range of PIFs (28.3, 60, 90 and 120 L min−1) and Vins (0.5, 0.75, 1, 1.5, 2, and 4 L) were used. The formulation was composed of spray dried Theophylline as a model drug with Lactohale® α lactose monohydrate carrier. The formulation was aerosolised using two DPIs; a low resistance Breezhaler® and high resistance Handihaler®. The formulation showed a consistent dose content uniformity with a Coefficient of Variation (CV) of 1.70%. The drug distribution on the surface of the carrier was obvious from the SE micrographs with some drug particles lodged into lactose crevices. The dose emission after the first inhalation (ED1) and total emitted dose (TED) of theophylline increased with PIF and Vin, irrespective of the inhaler device. However, the dose delivered was superior for the Handihaler® compared to Breezhaler®. Drug retention in the capsule and device was high at low PIFs and Vins and reduced after the second inhalation. Therefore, our study supports the recommendations for patients who cannot achieve sufficient PIF and Vin to inhale twice for each dose to ensure the better clinical outcome. Keywords: Peak inhalation flow, Inhalation volume, Theophylline, Handihaler®, Onbrez Breezhaler®
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spelling doaj.art-f392e1286d724fba90cc27120d0a01a42022-12-21T19:30:44ZengElsevierSaudi Pharmaceutical Journal1319-01642020-01-012817486The effect of inspiratory parameters after two separate inhalations on the dose emission of theophylline from low and high resistance dry powder inhalersMohamad Abadelah0Jumannah Al-Assadi1James Rooney2Hassane Larhrib3Department of Pharmacy and Pharmaceutical Sciences, University of Huddersfield, Huddersfield HD1 3DH, United Kingdom; Department of Pharmacy and Pharmaceutical Sciences, University of Tobruk, LibyaDepartment of Pharmacy and Pharmaceutical Sciences, University of Huddersfield, Huddersfield HD1 3DH, United KingdomDepartment of Pharmacy and Pharmaceutical Sciences, University of Huddersfield, Huddersfield HD1 3DH, United KingdomDepartment of Pharmacy and Pharmaceutical Sciences, University of Huddersfield, Huddersfield HD1 3DH, United Kingdom; Corresponding author at: Department of Pharmacy and Pharmaceutical Sciences, University of Huddersfield, Queensgate, Huddersfield HD1 3DH, United Kingdom.The dose emission from DPIs can be affected by the inspiratory parameters achieved by the patient as well as the device in-use. Conventional in-vitro dose emission methodology was used, but instead of using inhalation volume (Vin) of 2 or 4 L and peak inhalation flow (PIF) corresponding to 4 kPa, a range of PIFs (28.3, 60, 90 and 120 L min−1) and Vins (0.5, 0.75, 1, 1.5, 2, and 4 L) were used. The formulation was composed of spray dried Theophylline as a model drug with Lactohale® α lactose monohydrate carrier. The formulation was aerosolised using two DPIs; a low resistance Breezhaler® and high resistance Handihaler®. The formulation showed a consistent dose content uniformity with a Coefficient of Variation (CV) of 1.70%. The drug distribution on the surface of the carrier was obvious from the SE micrographs with some drug particles lodged into lactose crevices. The dose emission after the first inhalation (ED1) and total emitted dose (TED) of theophylline increased with PIF and Vin, irrespective of the inhaler device. However, the dose delivered was superior for the Handihaler® compared to Breezhaler®. Drug retention in the capsule and device was high at low PIFs and Vins and reduced after the second inhalation. Therefore, our study supports the recommendations for patients who cannot achieve sufficient PIF and Vin to inhale twice for each dose to ensure the better clinical outcome. Keywords: Peak inhalation flow, Inhalation volume, Theophylline, Handihaler®, Onbrez Breezhaler®http://www.sciencedirect.com/science/article/pii/S1319016419301410
spellingShingle Mohamad Abadelah
Jumannah Al-Assadi
James Rooney
Hassane Larhrib
The effect of inspiratory parameters after two separate inhalations on the dose emission of theophylline from low and high resistance dry powder inhalers
Saudi Pharmaceutical Journal
title The effect of inspiratory parameters after two separate inhalations on the dose emission of theophylline from low and high resistance dry powder inhalers
title_full The effect of inspiratory parameters after two separate inhalations on the dose emission of theophylline from low and high resistance dry powder inhalers
title_fullStr The effect of inspiratory parameters after two separate inhalations on the dose emission of theophylline from low and high resistance dry powder inhalers
title_full_unstemmed The effect of inspiratory parameters after two separate inhalations on the dose emission of theophylline from low and high resistance dry powder inhalers
title_short The effect of inspiratory parameters after two separate inhalations on the dose emission of theophylline from low and high resistance dry powder inhalers
title_sort effect of inspiratory parameters after two separate inhalations on the dose emission of theophylline from low and high resistance dry powder inhalers
url http://www.sciencedirect.com/science/article/pii/S1319016419301410
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