AERx Drug Delivery System

Liposomal Formulations

Intellectual Property

The Power Behind Effective Pulmonary Drug Delivery

Aradigm's 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.

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 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.

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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.

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Click on the image for a brief video depicting AERx Essence dosing

AERx Essence device

Read about AERx Capabilities


The new generation AERx inhaler (shown next to an iPhone)

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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.

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.

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AERx Strip dosage form Detail

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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.

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.

Cipolla D. Controlled Release Formulations for Inhalation: Soon to Appear? Inhalation Magazine. August, 2014.

Cipolla 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.

Cipolla D and Gonda I. Formulation Technology to Repurpose Drugs for Inhalation Delivery. Drug Discovery Today: Therapeutic Strategies. 2011;8(3-4):123-130. doi:10.1016/j.ddstr.2011.07.001.

Cipolla D, et al. Personalized Medicine: Development of Inhalation Systems Tailored to the Individual. Therapeutic Delivery. 2010;1(5):667-682.

Cipolla 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.

Chattopadhyay 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.

Sangwan 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. 2004;21(10):1777-1782.



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