The eFlow Open System nebuliser is a nebuliser configuration designed for a specific medication and target patient population. The drug is filled into the medication reservoir and completely used up during the nebulisation process (i.e. there is virtually no residual medication left in the medication reservoir). This enables highly efficient inhalation therapies. Each configuration is a specific eFlow version based on the eFlow Technology platform and supplied exclusively to the respective pharma partner.
The first drug-specific eFlow Open System includes the Altera® nebuliser handset for the administration of Cayston® (Gilead Sciences Inc.) commercialised since 2010, followed by the Zirela® nebuliser handset for QUINSAIR™ (Horizon) and the Tolero® nebuliser handset for Vantobra® (PARI Pharma) in 2015. In 2018 the Lamira® nebuliser for ARIKAYCE® (amikacin liposome inhalation suspension) (Insmed Incorporated) was approved by the US FDA.
Link to www.cayston.com
Link to www.horizonpharma.com
Link to www.pari.com/vantobra
Link to www.arikayce.com
With input from the pharmaceutical industry PARI's project team developed a nebuliser that has strong patent protection and is designed to prevent off label use. The eFlow Closed System is a specific nebuliser configuration featuring a proprietary prefilled ampoule instead of an open medication reservoir. The ampoule is pierced open when loaded into this nebuliser. Designed for enhanced usability for patients and a strong patent protection make this device unique for partners from the pharmaceutical industry.
The first eFlow Closed System was approved under the tradename Magnair® for the administration of Lonhala® (glycopyrrolate) Inhalation Solution (Sunovion Pharmaceuticals Inc.).
Link to www.lonhalamagnair.com
The eFlow Inline nebulizer system enables efficient aerosol delivery to mechanically ventilated patients in intensive medical care. It is integrated into the ventilator tubing and doesn´t interfere with the ventilator settings. The aerosol is introduced in the axial direction of the tubing, smoothly taken up by the air moving towards the patient without any added flow from the nebulizer thereby minimizing losses.
The eFlow Inline nebulizer remains in place during ventilation until the tubing is replaced. This reduces the handling and management efforts of the health care professional and avoids breaking up the circuit which may increase the risk for infections and potentially minimizes patient stress due to interrupted ventilation.
The nebulizer features a single dose removable reservoir (cartridge) to prevent off-label use with other drugs.
The ePort® controller (awarded the German Design Award 2021) operates the nebulizer. This control unit for multiple patient use is specifically designed for the needs in a hospital environment, provides guidance to the caregivers and can be used intuitively. It can be flexibly attached to e. g. the bedside of the patient or an IV pole.
PARI offers various e-Health options for adherence monitoring and data management that can be complemented by diagnostic devices.
The eTrack controller (eTrack), developed by PARI as part of the eFlow® Technology platform, features data transfer to facilitate objective and remote monitoring of adherence during inhalation therapy in clinical trials on the PARItrack web portal.
The eTrack controller can operate all of the different available eFlow nebuliser handsets. Nebulisation data are transferred to PARItrack web portal and can be accessed by healthcare professionals. The PARItrack web portal contains a dashboard that provides high level information on adherence and notifications. Individual patient data can be reviewed in detail and are graphically visualised for easy evaluation.
Adherence data may allow the investigator to select only the most adherent patients for the evaluation of drug efficacy and safety.
The eTrack controller and PARItrack web portal has already been used in several clinical studies in Europe, the US and Canada and was recently upgraded to also monitor lung function of patients with PARIs mobile spirometer mySpiroSense® Track, a Bluetooth® enabled version of the mySpiroSense®.
PARI’s electronic spirometers called SpiroSense® are the perfect complement to the eFlow® Technology platform to improve clinical outcome during drug development programs and to build up a patient monitoring system for commercialisation.
Applying the same high standards it applies to treatment of the airways, PARI offers the SpiroSense spirometer for the measurement of lung function, enabling diagnosis and long-term therapy monitoring using its novel heat wire technology for a precise, reliable spirometry measurement. Consisting of a professional PC spirometer (SpiroSensePro) for use by healthcare professionals, with the option of adding a mobile spirometer (mySpiroSense) for patients to use at home, the SpiroSense solution supports diagnosis and therapy monitoring in one seamless process.
The sinus cavities are challenging with respect to drug delivery. The bone structures forming these cavities are not very well perfused with blood. Therefore, systemically administered drugs require high doses to reach this target. Airborne droplets always require an active airstream to be transported into the human body. However, the sinusoidal cavities are fluid dynamic dead spaces which are only poorly ventilated. Vibrent Technology gently pushes aerosol droplets into the upper respiratory tract and applies vibrations once the aerosol droplets are in front of the entrances to the sinusoidal cavities. These vibrations cause a small pressure gradient between the outside and the inside of the sinusoidal cavities and therefore generate a slight airflow into the sinusoidal cavities which is capable of transporting an aerosol into these difficult to reach areas of the nose.
The gentle transportation of aerosol into the upper respiratory tract along with the superimposed vibration result in an outstanding distribution of droplets within the upper respiratory tract, which has been successfully proven in deposition studies in healthy volunteers as well as in chronic sinusitis patients. Moreover, the residence time of the drug within the upper respiratory tract is up to three times prolonged compared to a traditional nasal spray.