This platform nebulisation technology is low-cost, lightweight and portable, with the ability to efficiently delivernext-generation drugs such as proteins, peptides and DNA to the lung, for vaccination applications or in the treatment ofpulmonary diseases. The prototype for this technology has been extensively tested under laboratory conditions showing nebulisation at rates significantly higherthan nebulisers currently on the market. This allows a significant reduction in treatment times. The technology enables deep lung delivery with a uniform (monodispersed) aerosol size distribution within the 1-3 micron aerodynamic diameter range. It can be used with a range of therapeutic molecules, from peptides, proteins (including monoclonal antibodies), DNA, siRNA and microRNA; all of which show little (less than 10%; in the case of peptides, proteins and the monoclonal antibodies, this is less than 0.1%) degradation in the structure and functionality of the molecule. The delivery ofDNA vaccines to mice, rats and sheep has beendemonstrated wherein the inhaled DNA vaccine was shown to elicit a whole body immune response against influenza which is comparable to that when delivered through injections. The device is found to be extremely robust.In reliability testing, continuous nebulisation was carried out at peak nebulisation rates for over a month without failure.
The features of this technology include: No inhalation required for the generation ofaerosols, unlike all inhaler technology, which is problematic for patients who already have compromised lung function. Dosage can be tuned, unlike the one-size-fits-all inhalers, making it possible to adjust the delivery to a patient's size, age, gender and physiological profile. Chip-scale portable device can fit entirely in the palm of a person’s hand and weighs only approximately 100g. Comparatively, conventionalnebulisers are expensive and require a compressed air source or a large ultrasonic transducer,making them cumbersome to use and transport. Lowpower and high frequency operation of the nebuliser ensures that large therapeutic molecules such as proteins, peptides and nucleic acids which form the next generation drugs are not damaged during the nebulisation process - a problem that is prevalent in the majority of current inhalation technology. Instant on/off capability of the devicemeans that drug delivery can be tuned with tidal breathing, thus eliminating the loss of expensive drugs during exhalation and improving the administration of medication, even by the young and elderly. No needfor a nozzle or mesh, as required for a vibrating mesh nebuliser. This eliminates issues with clogging or fouling of the mesh / nozzle. Significantly increased nebulisation rates over existing devices. A nebulisation rate of 3 ml/min as compared to 0.4 ml/min of current atomisation devices, enabling a significant reduction in treatment times. Personal device doesn’t require hospital or medically trained staff.
This nebulisation platform technology has many potential applications: Medical:Treatment of lung diseases such as cystic fibrosis, asthma and Chronic Obstructive Pulmonary Disease (COPD) which include emphysema, chronic bronchitis, and some forms of bronchiectasis; delivery of vaccines and other therapeutics, for example influenza Non-medical applications: for example, fragrance delivery, consumer products; horticultural and agricultural.
There is currently no personalised delivery device commercially available for inhaled therapeutics, especially one that can be used for cancer treatment. Further, a device using this nebulisation technology is low cost, discrete and convenient to use. It does not require specially trained medical staff to use. It is sufficiently efficient to reduce wastage of medication, for example, very expensive cancer drugs. This technology is suitable for mass manufacture, is low cost and affordable by consumers.