IN THIS ISSUE - Drug Development & Delivery

Drug Development & Delivery July/August 2012 Vol 12 No 6
50
responsiveness in a murine model of
allergic asthma.
INHALED DELIVERY OF DIVERSE
CLASSES OF DRUGS
The potential of iSPERSE technology has
been validated not only with small molecule
drugs, but also macromolecule drugs (proteins,
peptides, antibodies) at therapeutically relevant
doses well in excess of those achievable by
traditional dry powder lactose blend
technologies. In vivo efficacy has been
demonstrated with small molecules for the
treatment of asthma and COPD, antibiotics in
mouse models of bacterial infection, as well as
lung and systemic delivery of macromolecules.
POTENTIAL APPLICATIONS
FOR ISPERSE
The attributes of iSPERSE give this
proprietary novel delivery platform the potential
to (1) deliver high drug payloads, (2) deliver low
potency drugs, (3) offer flexible formulation
options, (4) reduce side effects, (5) facilitate
straightforward manufacturing, (6) support the
formulation of small and large molecule drugs
(proteins and peptides), and (7) support drug
combinations (including triple drug
combinations or higher).
Expanding the viability of dry inhaled
powder delivery beyond select small molecules
to include proteins, peptides, and antibodies at
therapeutically relevant doses as well as triple,
quadruple, or higher drug combinations will
enable development of simple, convenient
inhaled therapies for a new and expanded range
of disease targets and patient populations. As
such, iSPERSE has the potential to be the
pulmonary delivery platform of choice for a
number of first-in-class and best-in-class inhaled
therapeutics.
Commercially, Pulmatrix is seeking
iSPERSE partnerships as well as advancing its
own iSPERSE-based drug formulations. In
terms of diseases that are likely near-term
candidates for iSPERSE clinical initiatives, a
number of proprietary iSPERSE drug
formulation candidates are now being advanced,
including small molecules, combinations, and
biologics in a variety of therapeutic areas,
including COPD, cystic fibrosis, asthma,
idiopathic pulmonary fibrosis (IPF), and non-CF
bronchiectasis.
To support the development of its own
pipeline as well as the iSPERSE partnering
programs, Pulmatrix has developed a complete
range of pulmonary drug formulation
capabilities that are integral to the successful
commercialization of the iSPERSE platform,
including:
• dry powder formulation and
manufacturing,
• dry powder physicochemical properties
optimization,
• aerosol characterization and method
development,
• dry powder inhaler selection and testing,
• preclinical efficacy/safety testing (in
vitro and in vivo), and
• clinical program operation and
management.
These platform and formulation
optimization capabilities will be offered to
iSPERSE partners. u
REFERENCES
1. Patton and Byron, Inhaling medicines: delivering drugs to
the body through the lungs. Nature Reviews Drug
Discovery, 2007;6:67-74.
2. Sung et al. iSPERSE TM : formulation and in vitro
characterization of a novel dry powder drug delivery
technology. Respiratory Drug Delivery Europe. 2011;2:411-
414.
3. Sung et al. Pulmonary Delivery of Combination Drug
Products via a Novel Dry Powder Delivery Technology.
Paper presented at the 11th US-Japan Symposium on Drug
Delivery Systems. Lahaina, Hawaii, December 15-20, 2011.
Pr
B I O G R A P H Y
Dr. Jean C. Sung is the Director of
Pharmaceutical Development at Pulmatrix, a
clinical-stage company discovering and
advancing novel respiratory therapeutics and
drug delivery technologies. She is responsible
for Pulmatrix’s formulation, process, and
analytical development functions. With prior
experience at Alkermes, Inc. and AIR, Inc.
(Advanced Inhalation Research), Dr. Sung has
spent more than a decade developing novel
particle engineering and formulation
technologies to advance respiratory dry
powder drug delivery. Dr. Sung earned her PhD
and MS in Engineering Sciences with a focus
on Biomedical Engineering from Harvard
University and her SB in Chemical Engineering
from Massachusetts Institute of Technology.