Impact of high shear blending on distribution of magnesium stearate on lactose for dry powder inhaled formulations

被引：1
作者：
Welle, Alexander [1 ]
Mehta, Mohit [2 ]
Marek, Karin [2 ]
Peters, Harry [3 ]
Van der Wel, Peter [4 ]
Imole, Olukayode [4 ]
机构：
[1] Karlsruhe Inst Technol, Inst Funct Interfaces, Karlsruhe Nano Micro Facil, Hermann-von-Helmholtz-Pl 1, D-76344 Eggenstein Leopoldshafen, Germany
[2] Harro Hofliger Verpackungsmaschinen GmbH, Helmholtzstr 4, D-71573 Allmersbach, Germany
[3] DFE Pharm GmbH, Kleverstr 187, D-47568 Goch, Germany
[4] Hosokawa Micron BV, Gildenstr 26, NL-7005 BL Doetinchem, Netherlands
来源：
INTERNATIONAL JOURNAL OF PHARMACEUTICS | 2023年 / 647卷
关键词：
Dry Powder Inhaler; Lactose; Magnesium Stearate; Time-of-Flight Secondary Ion Mass; Spectrometry; Powder Flow; SURFACE-ANALYSIS; CONTACT ANGLES; FINE LACTOSE; WETTABILITY; PERFORMANCE; BEHAVIOR; FLUIDIZATION; PARTICLES; MECHANISM;
D O I：
10.1016/j.ijpharm.2023.123503
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
The use of magnesium stearate along with lactose in Dry Powder Inhaler (DPI) formulations is increasing. The impact of different conditions of high shear blending on the distribution of magnesium stearate on lactose particles was investigated in this study. The formulated blends were manufactured using high shear blending of pre-blended coarse and fine lactose particles with 1.0% (w/w) magnesium stearate under different blending conditions, specifically blending speed and time. The effects of blending conditions on the distribution of magnesium stearate on lactose particles were clearly identifiable by characterizing the formulated blends by means of rheological evaluations, scanning electron microscopy, and chemical surface analysis using time-offlight secondary ion mass spectrometry (ToF-SIMS). Rheological properties were significantly affected in blends with magnesium stearate compared to blends without magnesium stearate. Blending speed exhibited a strong influence on the distribution of magnesium stearate on lactose surface, while blending time had relatively minor effect.
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页数：9
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