作者
Silvia Belotti, Alessandra Rossi, Paolo Colombo, Ruggero Bettini, Dimitrios Rekkas, Stavros Politis, Gaia Colombo, Anna Giulia Balducci, Francesca Buttini
发表日期
2014/8/25
期刊
International journal of pharmaceutics
卷号
471
期号
1-2
页码范围
507-515
出版商
Elsevier
简介
An amikacin product for convenient and compliant inhalation in cystic fibrosis patients was constructed by spray-drying in order to produce powders of pure drug having high respirability and flowability.
An experimental design was applied as a statistical tool for the characterization of amikacin spray drying process, through the establishment of mathematical relationships between six Critical Quality Attributes (CQAs) of the finished product and five Critical Process Parameters (CPPs).
The surface-active excipient, PEG-32 stearate, studied for particle engineering, in general did not benefit the CQAs of the spray dried powders for inhalation. The spray drying feed solution required the inclusion of 10% (v/v) ethanol in order to reach the desired aerodynamic performance of powders. All desirable function solutions indicated that the favourable concentration of amikacin in the feed solution had to be kept at 1% w/v level. It …
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S Belotti, A Rossi, P Colombo, R Bettini, D Rekkas… - International journal of pharmaceutics, 2014