The Power Behind Effective Pulmonary Drug Delivery
innovative AERx pulmonary drug delivery platform demonstrated performance
that is highly efficient and precise compared to other inhalation systems.
The performance of the AERx platform is due to its unique fine mist aerosol
generation systems combined with patented breath control technology. For
each therapeutic application, the AERx platform can be customized to
deliver drugs and biologics to treat lung diseases topically or to
transport therapeutics through the lung and into the bloodstream.
Hand-Held Delivery Devices
AERx first-generation inhalation delivery systems are sophisticated
electromechanical devices that were designed to achieve superior efficiency
and precision required for applications such as Type 1 and Type 2 diabetes
management with inhaled insulin, represented by the product AERx iDMS
previously licensed to our partner Novo Nordisk. The first-generation
devices include the two examples shown below. The first device is for
diabetes management. It features dose titration capability to one unit,
inhaled air temperature and flow control as well as electronic disease
management capabilities. The second device has similar features to the AERx
iDMS but is for pain management. Next to the device, the photograph shows
the user and prescriber electronic keys to prevent misuse and abuse of
controlled drug substances.
Delivery Device: AERx Essence®
AERx Essence is a small, palm-size all-mechanical device. The AERx Essence
system offers a level of performance (efficiency and reproducibility) close
to the first generation AERx system, but in a small, light and low-cost
package, yet retaining the high durability of the first generation systems.
new generation AERx inhaler (shown next to an iPhone)
Efficient, Precise Aerosol
Aradigm's AERx pulmonary drug delivery technology provides performance that
is at the leading edge in terms of efficiency of delivery to the lung and
reproducibility of dosing – not just in the laboratory but also as
determined in many human clinical trials.
method of delivery also often provides more rapid onset of action than
pills or patches because molecules are more immediately absorbed into the
bloodstream and avoid becoming compromised by gastrointestinal degradation
and metabolism. In fact, several biologics that could not be delivered by
oral administration have been delivered effectively using the AERx system.
Studies have shown that even well trained patients tend to develop improper
inhalation techniques over time, resulting in less effective therapy. To
ensure more consistent dosing and lasting beneficial effects, Aradigm's
AERx delivery system employs powerful breath control methods and
technologies to guide patients into proper breathing maneuvers. This
feature can also be customized for different patient groups, such as young
children or others with small lung volumes.
of the AERx System
• Small hand-held devices
• Adequate dose typically in one or two breaths
• Liquid formulation – applicable to many valuable biologics
• Very short administration time (typically 1-2 breaths)
• Highly efficient, precise aerosol delivery
• Breath control to ensure reliable drug delivery to lung
• Outstanding reproducibility in humans
• Simple to use
• Dose titration capabilities
• Eliminates needle-phobia issues and potential for needle-stick
AERx pulmonary delivery systems successfully delivered 15 different drugs
and biologics in human clinical trials.
AERx Strip® Technology
The single-use nozzle contained in each disposable AERx Strip dosage form
is created with a laser-machined array.
Nozzle hole exits are approximately 1 micron in diameter with a
uniform shape, to provide consistent, fine-particles drug delivery.
Strip dosage form Detail
ARADIGM scientists have published extensively on aerosol formulation and
pulmonary drug delivery. Following are citations from some of those works.
Gonda, I. et al.:
“Inhalation Delivery Systems with Compliance and Disease Management
Capabilities” Journal of Controlled Release 1998; 53:269-274.
J. et al.: “The AERx Aerosol Delivery System” Pharmaceutical
Farr, S.J. et al.
“AERx – Development of a
Novel Liquid Aerosol Delivery System” Respiratory Drug Delivery V.
Dalby, R.N. et al. (eds.) Interpharm Press Inc., Buffalo Grove, Illinois.
1996, pp. 175-184.
D. et al. “Aerosolization of Lipoplexes Using AERx® Pulmonary
Delivery System” AAPS Pharmaceutical Sciences 2002. 4(3):
Cipolla D and Gonda I. Inhaled Nicotine Replacement Therapy.
Asian J Pharm Sci. 2015;10(6)472-480. doi: 10.1016/j.ajps.2015.07.004.
D. Controlled Release Formulations for Inhalation: Soon to Appear?
Inhalation Magazine. August, 2014. http://www.inhalationmag.com/Content/SiteContent.aspx?ID=599.
D, Shekunov B, Blanchard J, Hickey T. Lipid-based Carriers for
Pulmonary Products: Preclinical Development and Case Studies
in Humans. Adv Drug Delivery Rev. 2014;75:53-80. doi: 10.1016/j.addr.2014.05.001.
D and Gonda I. Formulation Technology to Repurpose Drugs for
Inhalation Delivery. Drug Discovery Today: Therapeutic Strategies.
D, et al. Personalized Medicine: Development of Inhalation Systems
Tailored to the Individual. Therapeutic Delivery. 2010;1(5):667-682.
D and Johansson E. AERx Pulmonary Drug Delivery Systems. In:
Drugs and the Pharmaceutical Sciences, Modified Release Drug
Delivery Technology. Second Edition. 2008;184:563-572. Editors,
MJ Rathbone, J Hadgraft, MS Roberts, ME Lane. Published by Informa
Healthcare. April 2008.
P, Shekunov BY, Yim D, Cipolla D, Boyd B, Farr S. Production
of solid lipid nanoparticle suspensions using supercritical
fluid extraction of emulsions (SFEE) for pulmonary delivery
using the AERx system. Adv Drug Del Rev. 2007;59(6):444-453.
S, Agosti JM, Bauer LA, Otulana BA, Morishige RJ, Cipolla DC,
Blanchard JD, Smaldone GC. Aerosolized Protein Delivery in Asthma:
Gamma Camera Analysis of Regional Deposition and Perfusion.
J Aer Med. 2001;14,(2):185-195.
Cipolla D, Farr S, Gonda G, Otulana B. Delivery of Biologics
to the Lung. In: New Drugs for Asthma, Allergy and COPD. 2001;30:
20-23. Editors TT Hansel and PJ Barnes. Published by S. Karger
AG, Basel, Switzerland.
Deshpande D. et al. “Gamma scintigraphic evaluation of a miniaturized AERx
pulmonary delivery system for aerosol delivery to anesthetized animals using
a positive pressure ventilation system” J Aerosol Med 2005;18(1):34-44.
Davison S et al. “Pharmacokinetics and acute safety of inhaled testosterone
in postmenopausal women” J Clin Pharmacol. 2005;45(2):177-184.
Boyd B et al. “Effect of gender and device mouthpiece shape on bolus insulin
aerosol delivery using the AERx pulmonary delivery system” Pharm Res.