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Investigation to Identify the Influence of Mannitol as a Carrier on the Ex-Vivo Dose Emission and the In-Vitro Aerodynamic Dose Emission Characteristics of Dry Powder Inhalers of Budesonide

Aloum, Fatima
Publication Date
2020
End of Embargo
Supervisor
Assi, Khaled H.
Paluch, Krzysztof J.
Keywords
Surface energy, Ex-vivo, In-vitro, Aerodynamic characteristics, Crystallisation, Mannitol, Budesonide, Dry powder inhalers, Dose emission, Carrier
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Creative Commons License
The University of Bradford theses are licenced under a Creative Commons Licence.
Peer-Reviewed
Open Access status
Accepted for publication
Institution
University of Bradford
Department
School of Pharmacy, Faculty of Life Sciences
Awarded
2020
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PhD Thesis
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Abstract
This study provides, for the first time, an ex vivo comparative evaluation of formulations of budesonide with crystallised β-form mannitol, commercial DPI grade mannitol and lactose. The lactose-budesonide was the marketed Easyhaler® 200 g formulation. Ex vivo assessment of deposition using the Easyhaler® multi-dose high resistance inhaler with reservoir was compared with the RS01® single dose capsule low resistance inhaler at two different inhalation rates. Aerodynamic characteristics, flow and surface energies were investigated together with in vitro and ex vivo assessment of drug deposition. Dose emission was greater for all formulations with higher inhalation flow, indicating greater detachment of drug from carrier, and greater with the Easyhaler®, highlighting the importance of correct device for formulation. Emission was lowest at both inhalation rates for crystallised mannitol due to poor flowability associated with elongated particle shape which resulted in interception deposition. Surface energies were also implicated; closely matched polar surface energy of carrier and drug may be an important inhibiting factor. The promising aerodynamic characteristics of crystallised mannitol with the RS01® inhaler and lactose-budesonide from in vitro assessment were not supported by ex vivo results, highlighting the need for careful selection of device.
URI
http://hdl.handle.net/10454/19078
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Type
Thesis
Qualification name
PhD
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