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Novel pulmonary delivery technology.

THE PROBLEM WITH 'OLD-STYLE' INHALERS IS THAT THE DOSAGE IS OFTEN UNREGULATED, WHICH, ESPECIALLY IN CHILDREN, CAN LEAD TO POOR UPTAKE OF THE API. WHAT IS NEEDED IS A ROBUST SYSTEM THAT COMBINES A SOFT MIST WITH A BREATH-ACTIVATED, HAND HELD DEVICE. US SPECIALTY PHARMACEUTICAL COMPANY, VENTAIRA PHARMACEUTICALS, BELIEVES IT HAS DEVELOPED SUCH A DEVICE. IN ADDITION, THE SUBSYSTEM DESIGN APPROACH HAS ALLOWED THE COMPANY TO DESIGN AN INHALATION PLATFORM THAT CAN BE RECONFIGURED INTO A VARIETY OF EXTERNAL SHAPES AND SIZES ALLOWING IT TO PHYSICALLY ADAPT TO MARKET DEMANDS AND FULFILL CONSUMER REQUIREMENTS.

The Ventaira inhaler uses its Mystic inhalation technology otherwise known as electrohydrodynamic technology, to efficiently reproduce aerosol droplets in the 1-5pm range for pulmonary delivery. The EHD (electohydrodynamic) process applies an electrical field over a flowing liquid. This electrical stress overcomes the surface tension of the liquid causing it to disperse into uniformly sized droplets. Ventaria has designed and built a hand held device from injection molded plastic parts that uses conventional batteries and a custom electronics board. Performance of the highly efficient device is reproducible, robust over a range of temperatures, relative humidities and inhalation flow rates, and is independent of device orientation. Recent in vivo trials demonstrated that the technology gets more drug deep into the lung than any device on the market, or in development, today.

Technology

The Mystic technology generates non-pressurized, nearly mono-dispersed respirable aerosols by an electrostatic spray process called EHD. This is a patented process by which an electric field is applied to a conductive liquid. This is accomplished by transferring high voltage DC (direct current) through an array of electrodes, creating a field of discharge ions in front of a multi-spray site nozzle. These cations induce an accumulation of charge at the liquid's surface causing a Taylor cone to form at each spray site. As the surface charge overcomes the surface tension of the liquid, a fine mist of nearly mono-dispersed droplets is formed, and as the droplets pass through the field of ions their charge is subsequently neutralized (Figure 1).

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The technology produces low velocity clouds of uniformly sized particles with extremely high efficiencies, enabling consistent delivery of drug throughout the lungs. The non-pressurized aerosol mist is easily inhaled using the patient's normal inspiratory breath.

Formulation

This liquid-based formulation technology has several advantages over other existing aerosol formulation methodologies, including that it allows for rapid formulation development with new APIs and only requires small amounts of material to determine feasibility. This advantage facilitates rapid initiation of early phase clinical studies.

Currently, Ventaira utilizes a highly ethanolic formulation vehicle that has allowed a series of compounds with a wide array of physical properties and therapeutic applications to be formulated and tested. The technology has also demonstrated its use in formulating stable solutions of a range of compounds that exist as free acids or bases, oils and volatile liquids: there is no need to identify a stable salt form. Ethanolic formulations are also self-preserving by nature, thus maintaining the microbial-free integrity of the formulation.

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Design

The device is a small, hand-held, battery-powered, breath-activated inhaler that delivers therapeutic drugs to the pulmonary system (Figure 21. It consists of four major systems. These include the mouthpiece/nozzle assembly, the drug container, the metering system, and the power supply/electronics board. Aerosolization of the formulation occurs within mouthpiece/nozzle assembly, which contains the spray sites and discharge electrodes.In the future, the device electronics could be easily modified to provide the ability to offer programmable dose controls, patient compliance monitoring and electronic lock-out for pain management therapies.

Performance

The device was evaluated for emitted dose efficiency and fine particle fraction, using cascade impaction, to examine the reproducibility of the design. Excellent reproducibility was seen, both in terms of the amount of drug delivered and in the generation of particles of less than 5.8pm, a size range expected to penetrate the lungs (Figures 3-4).

The most important attribute of an inhalation device is that it performs reliably and reproducibly over the course of the product's use and is not sensitive to normal types of mishandling. The research carried out in developing the inhaler has highlighted ways in which a consistent amount of drug can be delivered even after successive dropping. This is a function of the mechanical ruggedness that can be designed into such a device (Figure 51. Additionally, the research showed that consistent performance over a period of time, such as one month, was achievable and that the amount of drug delivered remained consistent even when the device was not used for several days (Figure 6).

Research from Ventaira has shown that there are new avenues for inhalation therapy and such developments are applicable to a platform of drugs from different chemical and therapeutic areas. Recent in-vivo trials have demonstrated that Mystic technology delivers a higher percentage of drug to the lung than any device on the market. The performance of Ventaira's inhalation device is shown to be reproducible and robust over a range of temperatures, relative humidities, inhalation flow rates and is independent of device orientation.

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Title Annotation:MEDICAL DEVICES
Publication:Pharma
Geographic Code:1USA
Date:Jan 1, 2007
Words:863
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