eBook: Formulation of Dry Powder Inhaler - 40
processes currently dominating
the commercial market. Simulspray
also eliminates the need for
common spray solvent between
APIs, which previously hindered
combinations involving biotherapeutics
and poorly soluble small
molecules. Lonza demonstrated
three combinations relevant to
lung cancer treatment; all three
combinations included bevacizumab
in conjunction with another
drug. The first combination
included bevacizumab and
erlotinib, an EGFR inhibitor that
is used when non-small cell lung
cancer has an EGFR mutation.
The second combined it with paclitaxel,
a chemotherapy, and the
third with cisplatin, the standard
of care for non-small cell lung
cancer.
Both erlotinib and paclitaxel
have low solubility, and cisplatin,
as an aqueous solution, possesses
chemical stability issues.
Lonza experimented with four
different mass ratios ranging
from 1:5 to 2:1, because cisplatin
is decently soluble in water but
possesses stability issues in an
aqueous solution.
Lonza found that for all of its
formulations, the geometries
and surfaces identified through
SEM imaging indicate that each
combination is adequately
blended without the necessity
of additional processing steps.
Figure 3. In its proof-of-concept study, Lonza was able to achieve drug concentrations within 90
percent of the target for all nine of its formulations (Source: Lonza).
Each was found to possess aerosol
properties that are targeted
to the deep lung. Lonza used
an aerodynamic particle sizer
to look at the mass median,
aerodynamic diameter, and the
geometric standard deviation
of each powder and found that
all were less than three microns
in size, ideal for deep lung delivery.
The team performed a
fast-screening impactor test
to determine the fine particle
dose of each drug, as well as an
evaluation to determine that
the materials produced had a
uniform particle size distribution.
Lonza was able to adequately
demonstrate both for
each combination; additionally,
Lonza was able to demonstrate
that simul-spray formulations
retain the anti-VEGF properties
of bevacizumab.
Ultimately, simul-spray
was
found to enable unique formulation
combinations, with the
formulations tested achieving
target drug concentration, good
aerosol properties, and anti-VEGF
bioactivity. Simul-spray was also
found to be useful for dose escalation
studies where delivered
dose is fill-dependent, as one
active stream and one placebo
stream can be used to vary active
concentration without changing
individual formulations.
40
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eBook: Formulation of Dry Powder Inhaler
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