|
The Power Behind Effective Pulmonary Drug Delivery
Aradigm's
innovative pulmonary drug delivery platform AERx demostrated performance
that is highly efficient and precise compared to other inhalation systems.
The performance of AERx 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.
AERx First-Generation 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 lead product AERx iDMS 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.
Novo Nordisk has announced that they intend to commercially
launch with a new device that will retain the key features but
it will be significantly smaller and lighter than this first
generation system. 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.
 |
 |
| Diabetes
Management |
Pain
Management |
AERx
Second-Generation 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.
Efficient,
Precise Aerosol Generation
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.
This
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.
Advanced Breath-Control
Technology
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.
Additional
Advantages of the AERx System
• Small hand-held devices
• Adequate dose typically in one or two breaths
• Liquid formulation – applicable to many valuable biologics
and drugs
• 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
injury
Promising Applications
AERx pulmonary delivery systems successfully delivered 15 different drugs
and biologics in human clinical trials. The most advanced product for the
treatment of diabetes – AERx iDMS - is currently in Phase 3 studies.
AERx Strip Technology
The single-use nozzle contained in each disposable AERx Strip 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
Detail |
Nozzle
Detail |
Scientific Publications
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.
Schuster,
J. et al.: “The AERx Aerosol Delivery System” Pharmaceutical
Research 1997;14(3):354-357.
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.
Desphande
D. et al. “Aerosolization of Lipoplexes Using AERx® Pulmonary
Delivery System” AAPS Pharmaceutical Sciences 2002. 4(3): 1-10.
|
Drug Delivery System 
AERx
Inhalation Technology Platform