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.
| Identifer | oai:union.ndltd.org:BRADFORD/oai:bradscholars.brad.ac.uk:10454/19078 |
| Date | January 2020 |
| Creators | Aloum, Fatima |
| Contributors | Assi, Khaled H., Paluch, Krzysztof J. |
| Publisher | University of Bradford, School of Pharmacy, Faculty of Life Sciences |
| Source Sets | Bradford Scholars |
| Language | English |
| Detected Language | English |
| Type | Thesis, doctoral, PhD |
| Rights | <a rel="license" href="http://creativecommons.org/licenses/by-nc-nd/3.0/"><img alt="Creative Commons License" style="border-width:0" src="http://i.creativecommons.org/l/by-nc-nd/3.0/88x31.png" /></a><br />The University of Bradford theses are licenced under a <a rel="license" href="http://creativecommons.org/licenses/by-nc-nd/3.0/">Creative Commons Licence</a>. |
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