Technical challenges in obtaining an optimized powder/DPI combination for inhalation delivery of a bi-component generic drug

Arkadiusz Hejduk , Agnieszka Urbańska , Andrzej Osiński , Piotr Łukaszewicz , Maciej Domański , Tomasz Robert Sosnowski


Development of bi-component generic orally inhaled product (OIP) delivered from dry powder inhaler (DPI) is challenging due to the necessity to demonstrate the similarity of size distribution of both APIs in inhaled aerosol. The effects of selected technical factors on OIP development are investigated. The Monodose inhalers with different aerodynamic resistance were used to aerosolize generic fluticasone/salmeterol formulations. Flow dynamics in the DPIs was analyzed during realistic use. The effects of lactose grade, capsule types and blending equipment on aerosol particle size were studied with compendial methods. The best dispersion of bi-component powder was obtained in a medium-resistant (∼0.108 hPa0.5 min L−1) Monodose DPI as compared to low- and high-resistant devices. All studied technological factors had influence on the fine particle dose of each API and fluticasone/salmeterol mass ratio. It was demonstrated that the selected Monodose inhaler in combination with the newly developed bi-component drug formulation was able to reproduce the quality of inhalable aerosol obtained from Diskus DPI. Since powder dispersion depends on the energy available in a single breath, an optimized DPI is needed in generic OIP. By adjusting several technological factors it is possible to obtain the reproducible product with the required dose of each aerosolized APIs.
Author Arkadiusz Hejduk - [Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.]
Arkadiusz Hejduk,,
, Agnieszka Urbańska - [Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.]
Agnieszka Urbańska,,
, Andrzej Osiński - [Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.]
Andrzej Osiński,,
, Piotr Łukaszewicz - [Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.]
Piotr Łukaszewicz,,
, Maciej Domański - [Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.]
Maciej Domański,,
, Tomasz Robert Sosnowski (FCPE / CIPE)
Tomasz Robert Sosnowski,,
- Chair of Integrated Process Engineering
Journal seriesJournal of Drug Delivery Science and Technology, ISSN 1773-2247
Issue year2018
Publication size in sheets0.5
Keywords in EnglishDPI, generic drugs, product development, inhalation, fluticasone, salmeterol
ASJC Classification3003 Pharmaceutical Science
Languageen angielski
Hejduk A. (i in.) - Technical challenges in...pdf 1.1 MB
Score (nominal)15
Score sourcejournalList
ScoreMinisterial score = 15.0, 01-04-2020, ArticleFromJournal
Publication indicators WoS Citations = 0; Scopus Citations = 1; GS Citations = 3.0; Scopus SNIP (Source Normalised Impact per Paper): 2018 = 0.823; WoS Impact Factor: 2018 = 2.606 (2) - 2018=2.155 (5)
Citation count*3 (2020-06-01)
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* presented citation count is obtained through Internet information analysis and it is close to the number calculated by the Publish or Perish system.
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