Effects of process variables on the properties of spray-dried mannitol and mannitol/disodium cromoglycate powders suitable for drug delivery by inhalation

Katarzyna Kramek-Romanowska , Marcin Odziomek , Tomasz Robert Sosnowski , Leon Gradoń

Abstract

Understanding the influence of process conditions on the properties of pharmaceutical products is critical to their optimal and cost-effective design and manufacture. The aim of this study was to investigate the effect of changing processing variables on the physical properties of spray-dried mannitol and co-spray-dried mannitol/disodium cromoglycate (DSCG) formulations intended for therapeutic inhalation. A 24 full factorial design was performed to assess the consequences of altering the following spray-drying parameters: feed flow rate, nozzle gas flow rate, drying gas inlet temperature, and aspirator capacity (drying gas flow rate). Aqueous solutions of mannitol and mannitol/DSCG were spray-dried using a laboratory-scale spray dryer, and the products were characterized in terms of particle size distribution, powder yield, and particle morphology. These physical properties were found to be affected mainly by two processing variables: nozzle gas flow rate and drying gas inlet temperature. In addition, optimal conditions for the production of inhalable mannitol powders were obtained, generating a yield of 90\% by weight of round and smooth particles with a volume median diameter of 4.28 ?m. Mannitol/DSCG formulations co-spray-dried in the same conditions had similar characteristics. The results of this study can be applied to controlled formulation of various spray-dried powders for inhalation.
Author Katarzyna Kramek-Romanowska KIPZ
Katarzyna Kramek-Romanowska,,
- Chair of Integrated Process Engineering
, Marcin Odziomek KIPZ
Marcin Odziomek,,
- Chair of Integrated Process Engineering
, Tomasz Robert Sosnowski KIPZ
Tomasz Robert Sosnowski,,
- Chair of Integrated Process Engineering
, Leon Gradoń KIPZ
Leon Gradoń,,
- Chair of Integrated Process Engineering
Journal seriesIndustrial & Engineering Chemistry Research, ISSN 0888-5885
Issue year2011
Vol50
No24
Pages13922-13931
Publication size in sheets0.5
DOIDOI:10.1021/ie2006998
URL http://dx.doi.org/10.1021/ie2006998
Languageen angielski
File
Kramek-Romanowska K. (i in.) - Effects of Process....pdf 3.83 MB
Score (nominal)35
Publication indicators WoS Impact Factor [Impact Factor WoS]: 2011 = 2.237 (2) - 2011=2.53 (5)
Citation count*17 (2018-06-18)
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