Table 1.
Hypotheses concerning the working mechanism of added lactose fines.
Table 2.
Particle size distributions of the mixture components (average (SD); n = 3).
Table 3.
Formulations studied and their total carrier surface coverage (CC) by fine components.
Figure 1.
Representative SEM images of the pure mixture components.
Figure 2.
Representative SEM images of mixtures.
Top: mixtures containing 4% budesonide and 4% fine lactose fines. Bottom: mixtures containing 4% budesonide and 4% coarse lactose fines. Images on the right hand side are a magnification of images on the left hand side.
Figure 3.
The effects of added lactose fines on drug detachment over a range of flow rates.
A) effects of 4% fine lactose fines (FLF) or 4% coarse lactose fines (CLF) on drug detachment of 0.4% budesonide mixtures and B) for 4% budesonide mixtures. Error bars represent maximum and minimum values measured (n = 5).
Figure 4.
Drug detachment of 4% budesonide mixtures at 30 L/min as a function of added fines content.
FLF = fine lactose fines; CLF = coarse lactose fines. Error bars represent maximum and minimum values measured (n = 5).
Figure 5.
The influence of mixing order on the effects of added fines on drug detachment.
A) mixtures containing 0.4% budesonide and 4% fine lactose fines (FLF); B) mixtures containing 0.4% budesonide and 4% coarse lactose fines (CLF); C) mixtures containing 4% budesonide and 4% CLF. Drug detachment versus flow rate profiles of mixtures containing only 0.4% or 4% of budesonide (mixed for 5 or 10 minutes) are shown as a reference. Fine components were mixed separately by mixing one component with the carrier for 5 minutes, after which the second component was added and mixing was continued for another 5 minutes. Simult. = drug and fines mixed simultaneously with the carrier material for 5 or 10 minutes. Error bars represent maximum and minimum values measured (n = 5).