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The match between adhesive mixture powder formulations for inhalation and the inhaler device

Thalberg, Kyrre LU ; Ahmadi, Rasia ; Stuckel, Jackie ; Elfman, Peter and Svensson, Mårten (2023) In European Journal of Pharmaceutical Sciences 186.
Abstract

The device or the formulation? Which one governs drug dispersibility from the inhaler? To address this question, three budesonide-containing reservoir DPIs: Novopulmon Novolizer®, Giona Easyhaler® and DuoResp Spiromax®, were analyzed using the Next Generation Impactor, NGI. Thereafter, the devices were carefully opened, emptied, and formulations were switched between devices. Finally, three ‘prototype’ formulations with carriers of different particle size were produced and tested in the Novolizer and Easyhaler devices. Among the DPI products, the two devices which have a flow path with a cyclone-type geometry, i.e., the Novolizer and the Spiromax, yielded a fine particle fraction, FPF, above 40%. The Easyhaler, which has a straight... (More)

The device or the formulation? Which one governs drug dispersibility from the inhaler? To address this question, three budesonide-containing reservoir DPIs: Novopulmon Novolizer®, Giona Easyhaler® and DuoResp Spiromax®, were analyzed using the Next Generation Impactor, NGI. Thereafter, the devices were carefully opened, emptied, and formulations were switched between devices. Finally, three ‘prototype’ formulations with carriers of different particle size were produced and tested in the Novolizer and Easyhaler devices. Among the DPI products, the two devices which have a flow path with a cyclone-type geometry, i.e., the Novolizer and the Spiromax, yielded a fine particle fraction, FPF, above 40%. The Easyhaler, which has a straight mouthpiece outlet, produced an FPF of 18%. When the Novopulmon and the DuoResp formulations were assayed in the Easyhaler device, poor fine particle fractions were obtained. To the contrary, the Giona formulation produced a high FPF when tested in the Novolizer device. The results clearly show that the device is the dominating factor to dispersibility for the investigated products. Along the same lines, all three ‘prototype’ formulations produced high fine particle fractions in the Novolizer device, with the formulation with the largest carrier giving the best performance. Tested in the Easyhaler device, the prototype formulations produced low fine particle fractions, but interestingly, the formulation with the smallest carrier particle size yielded the highest FPF. It can be concluded that there is a link between inhaler design and the effect of carrier particle size, where larger carriers provide better dispersion in cyclone-type devices while smaller carriers seem to be more beneficial for inhalers which has a straight flow path for the powder formulation.

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author
; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Adhesive mixture, Dispersibility, Dry powder inhaler, Fine particle fraction, Next generation impactor, Reservoir device
in
European Journal of Pharmaceutical Sciences
volume
186
article number
106457
publisher
Elsevier
external identifiers
  • pmid:37116546
  • scopus:85154560702
ISSN
0928-0987
DOI
10.1016/j.ejps.2023.106457
language
English
LU publication?
yes
id
adc3f531-e3af-4cb4-bd19-2843622f8ba8
date added to LUP
2023-06-21 13:44:45
date last changed
2024-04-19 23:02:26
@article{adc3f531-e3af-4cb4-bd19-2843622f8ba8,
  abstract     = {{<p>The device or the formulation? Which one governs drug dispersibility from the inhaler? To address this question, three budesonide-containing reservoir DPIs: Novopulmon Novolizer®, Giona Easyhaler® and DuoResp Spiromax®, were analyzed using the Next Generation Impactor, NGI. Thereafter, the devices were carefully opened, emptied, and formulations were switched between devices. Finally, three ‘prototype’ formulations with carriers of different particle size were produced and tested in the Novolizer and Easyhaler devices. Among the DPI products, the two devices which have a flow path with a cyclone-type geometry, i.e., the Novolizer and the Spiromax, yielded a fine particle fraction, FPF, above 40%. The Easyhaler, which has a straight mouthpiece outlet, produced an FPF of 18%. When the Novopulmon and the DuoResp formulations were assayed in the Easyhaler device, poor fine particle fractions were obtained. To the contrary, the Giona formulation produced a high FPF when tested in the Novolizer device. The results clearly show that the device is the dominating factor to dispersibility for the investigated products. Along the same lines, all three ‘prototype’ formulations produced high fine particle fractions in the Novolizer device, with the formulation with the largest carrier giving the best performance. Tested in the Easyhaler device, the prototype formulations produced low fine particle fractions, but interestingly, the formulation with the smallest carrier particle size yielded the highest FPF. It can be concluded that there is a link between inhaler design and the effect of carrier particle size, where larger carriers provide better dispersion in cyclone-type devices while smaller carriers seem to be more beneficial for inhalers which has a straight flow path for the powder formulation.</p>}},
  author       = {{Thalberg, Kyrre and Ahmadi, Rasia and Stuckel, Jackie and Elfman, Peter and Svensson, Mårten}},
  issn         = {{0928-0987}},
  keywords     = {{Adhesive mixture; Dispersibility; Dry powder inhaler; Fine particle fraction; Next generation impactor; Reservoir device}},
  language     = {{eng}},
  publisher    = {{Elsevier}},
  series       = {{European Journal of Pharmaceutical Sciences}},
  title        = {{The match between adhesive mixture powder formulations for inhalation and the inhaler device}},
  url          = {{http://dx.doi.org/10.1016/j.ejps.2023.106457}},
  doi          = {{10.1016/j.ejps.2023.106457}},
  volume       = {{186}},
  year         = {{2023}},
}