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Outline
1. Why use the laser diffraction technique for ordered mixtures?
2. Method development
3. Results for an AZ Development compound
4. Conclusion and outlook
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NGI + UPLC
Speed
A few minutes
Typically 1 day
Diameter measured
Volume equivalent
Aerodynamic
Weight
Volume
Mass
Size range
0.5 185 m
0.1 10 m
Chemically sensitive?
No
Yes
Method development
Off the shelf version
Inhaler
Laser
No recirculation !
No contamination of lenses !
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(0-10 %)
Note:
Fraction < 5 m
results independent
of fill weigh!
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Results: Repeatability
Consecutive measurements at patient relevant deaggregation flow (60 lpm)
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< 5 m
Increased flow gives more fines and lower VMD (compare MMAD)
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Higher FPF
Lower VMD
< 5 m
x10
Lower FPF
Higher VMD
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10
Q = 7 2 lm in
-1
Q = 8 0 lm in
-1
Composition:
5 % API
3 % Lactose fines
89 % Lactose carriers
3 % MgSt
10
20
30
40
50
60
70
Im p a c t o r F in e P a r t ic le F r a c t io n ( % < 5 m )
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Conclusions
1. We have developed a robust laser diffraction method for
ordered mixtures giving low shot-to-shot variability.
=>useful as screening tool for FPF-predictions in formulation development
Outlook
1. Understand the role of lactose fines. Thesis work in progress.
2. Improve dispersion tubes further.
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T: +44(0)20 7604 8000, F: +44 (0)20 7604 8151, www.astrazeneca.com
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