eBook: Formulation of Dry Powder Inhaler - 39
administered by inhaler, while the fourth experimental
group received dry powder bevacizumab and injected
cisplatin in combination.
Ultimately, researchers found that inhaled bevacizumab
was effective in vivo. Importantly, the study
found that inhaled bevacizumab in combination
with IP cisplatin reduces tumor mass as much as the
positive control (the second group) at one-tenth the
bevacizumab dose. Additionally, inhaled bevacizumab
alone was found to reduce tumor burden significantly
when compared with the negative control. In a
maintenance study, inhaled bevacizumab was found
to prolong survival after chemotherapy was ended.
Case Study 2: Simul-spray
Bevacizumab/Small Molecule
Combination Therapy
Combination therapies are a critical intervention in
the treatment of rare and intractable diseases, as
these formulations can simplify care and improve
patient adherence. By combining two APIs into a
single drug substance, manufacturers can reduce
the number of dosage forms required to treat a patient,
helping streamline their care and potentially
reduce cost. The primary challenge to this historically
has been the difficulty combining certain APIs into
a single formulation. In a recent study published by
MDPI and led by Lonza, simul-spraying was found
to preserve the biologic activity of the antibody,
achieve target drug concentration, and possess
aerosol properties suitable for pulmonary delivery
in three combination case studies with erlotinib, cisplatin,
and paclitaxel.
To conduct its study, Lonza modified its system so
that its spray dryer utilized two separate solution
feeds; each feed is independently routed into a
single spray dryer and atomized through Lonza's
simul-spray twin atomizer, which has separate liquid
streams and separate gas atomization streams. The
two distinct powders produced are then collected
into a single cyclone, resulting in an intimately mixed
blend of particles without the necessity of a single
formulation. This is important, as most biotherapeutics
are incompatible with the milling and blending
Figure 2. Lonza's simultaneous spray drying has been shown to produce well-blended drug combinations, as pictured above.
39
eBook: Formulation of Dry Powder Inhaler
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