New insights into respirable protein powder preparation using a nano spray dryer

被引:97
作者
Buerki, K. [1 ]
Jeon, I. [1 ]
Arpagaus, C. [2 ]
Betz, G. [1 ]
机构
[1] Univ Basel, Ind Pharm Lab, Dept Pharmaceut Sci, CH-4056 Basel, Switzerland
[2] BUCHI Lab Tech AG, CH-9230 Flawil, Switzerland
关键词
Spray drying; Nano spray dryer; Inhalation; beta-Galactosidase; Trehalose; PROCESS VARIABLES; BETA-GALACTOSIDASE; TREHALOSE MATRICES; GLASS-TRANSITION; DRYING PROCESS; DRIED POWDERS; NANOPARTICLES; CRYSTALLIZATION; OPTIMIZATION; RETENTION;
D O I
10.1016/j.ijpharm.2011.02.012
中图分类号
R9 [药学];
学科分类号
100702 [药剂学];
摘要
In this study the Nano Spray Dryer B-90 (BUCHI Labortechnik AG, Flawil, Switzerland) was evaluated with regard to the drying of proteins and the preparation of respirable powders in the size range of 1-5 mu m. S-Galactosidase was chosen as a model protein and trehalose was added as a stabilizer. The influence of inlet temperature, hole size of the spray cap membrane and ethanol concentration in the spray solution was studied using a 33 full factorial design. The investigated responses were enzyme activity, particle size, span, yield and shelf life. Furthermore, the particle morphology was examined. The inlet temperature as well as the interaction of inlet temperature and spray cap size significantly influenced the enzyme activity. Full activity was retained with the optimized process. The particle size was affected by the hole size of the spray cap membrane and the ethanol content. The smallest cap led to a monodisperse particle size distribution and the greatest yield of particles of respirable size. Higher product recovery was achieved with lower inlet temperatures, higher ethanol contents and smaller cap sizes. Particle morphology differed depending on the cap size. The protein exhibited higher storage stability when spray dried without ethanol and when a larger spray cap size was used. (C) 2011 Elsevier B.V. All rights reserved.
引用
收藏
页码:248 / 256
页数:9
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