Platform No. I - Alphazer®
The Alphazer® is a unique portable pneumatic system for generating soft mist based on a porous medium.
Its distinctive technology enables nebulization of aqueous solutions via a hand held device.
Comprising a durable unit and consumable disposable cartridge, not requiring cleaning, the Alphazer® presents a hassle-free no maintenance “plug and play” device, for the delivery of active substances to the lungs.
Moreover, the system generates a soft mist cloud which requires neither breath coordination nor manipulation on the user’s side.
The Alphazer® technology can be employed in localized lung deposition as well as in systemic drug delivery. It is suitable for a variety of potential applications, with preliminary experiments demonstrating its capability to tailor performance by changing solution physicochemical characteristics and the porous membrane design itself.
Essentially, the Alphazer® is comprised of a durable unit and adjoining consumable sub-assembly. The consumable sub-assembly accommodates all the device elements that come into contact with either the formulation (reservoir, porous media, formulation routing etc.) or the user’s mouth, while the devices’ durable sub-assembly holds all the remaining device elements not coming in contact with the formulation (e.g. battery, user interface control, non-contact formulation management components etc.).
The system operates by applying a pressurized airflow through a thin disk of porous material (PM). The PM has an open porous structure with a complex interlinked system of capillaries. Solutions ready for aerosolization are then deposited on the top surface of the disk at the point of user inhalation where dynamic interactions between the PM geometry, airflow and fluid properties result in aerosol generation. Aerosol is generated without the application of heat.
The technology is geared towards providing a simple, robust, user-friendly, disposable device that can operate as both an inhaler and nebulizer and that can generate “soft mist” aerosols with a low MMAD (below 2 microns) and high fine particle fraction.
The platform is ideally suitable for deep lung, systemic delivery of drugs and Combo treatments.
The Alphazer® technology stands out from the crowd of existing products with the ability to produce droplet sizes ranging from sub-micron to microns, all in a reproducible fashion, thus manifesting the system’s suitability in catering to numerous potential applications.
The Alphazer® has demonstrated good PK (pharmacokinetic) characteristics when used with nicotine, displaying rapid onset similar to that achieved with a combustion cigarette.
Devices have now entered the design-to-manufacture phase and will shortly be ready for additional clinical trials.
The platform benefits from a solid intellectual property foundation consisting of seven patent families, three of which have been granted.
The technology shows at its current stage that it can be employed in conventional therapies for local administration in both lung and nose.
- Hand held
- Low MMAD
- High FPF
- “Soft mist”
- Has the base architecture to accommodate suitable connectivity
- Disposable aerosolizing element overcome the need to wash and clean and minimizes contamination associated risks
The Alphazer® platform offers a unique proposition for pharmaceutical companies that are currently in early stage clinical trials with new therapeutic entities (NTEs), intended to be delivered to the central and deep lungs, including systemic delivery.
- The MMAD of the droplets produced by the Alphazer range from 0.5 µm to 7 µm depending on the physiochemical properties of the solution.
- The effect of solution physiochemical properties (viscosity, surface tension, ionic strength, etc.) on the aerosol produced by the Alphazer platform has been thoroughly investigated and can be beneficial in formulating towards desired properties.
- Physical factors such as air velocity and aerosolization times can be easily tuned through the control unit and assist in adapting the device to the formulation.
- The use of disposable aerosolization elements circumvents the need for device cleaning and maintenance during studies.
Platform No. II - Aquaphazer™
Safety first – Propylene glycol and vegetable glycerin, ubiquitously found in electronic cigarettes and vaping pens are both considered non-toxic when delivered orally yet pose a potential health risk when heated in thermal vaporizing devices. Heated PG and VG emit Formaldehyde and acetaldehyde, chemical agents categorized as carcinogenic. Research suggests that even minute doses of PG and VG attenuate growth of human lung and upper airway cells, when delivered in vaporous puffs.
Geared towards safety and user experience, the Aquaphazer’s unique thermal platform delivers aqueous formulations with no harmful excipients, such as PG or VG and is thus aimed at delivering nicotine and cannabinoids in a safer manner compared to currently existing thermal devices.. The platform is content and dose controlled, delivering accurate and consistent doses of active substance to the user.
A unique heating element facilitating the production of high grade aerosol from aqueous formulations containing volatile compounds, free of oils and other controversially harmful materials such as Propylene glycol and Vegetable glycerine.
The Aquaphazer™ introduces liquid formulation onto a unique heated surface, generating an ultra-fine cloud of droplets, and is optimized for deep lung deposition
The technology is in its design-to-manufacture development stage and is protected by International patent applications.
Platform No. III
Poorly soluble compounds are difficult to aerosolize using nebulizing devices such as jet nebulizers and vibrating mesh nebulizers. Furthermore, existing aerosolization technologies have great difficulties in generating droplets that are smaller than 3 microns. The company’s latest technology targets applications facilitating the delivery of poorly soluble compounds which necessitate high drug payloads yet require droplets smaller than 3 microns for efficient delivery to the central and peripheral lung. At an early developmental stage , In vitro measurements have already shown great promise in aerosolizing inhaled corticosteroids and enabling efficient combination therapy.