Business and innovation

Next Generation Nebuliser

The nebuliser technology enables inhalation delivery of a wide range of drugs, including marketed formulations and novel high value therapeutics such as biologics, nanomedicines and vaccines. Current nebuliser technologies have limited acceptable formulation; delivery of formulations with low surface tension, suspensions and biologics has proven to be challenging with current devices. This has resulted in limited availability of drugs for patients.

The majority of global pandemics, such as COVID-19, are respiratory infections and the availability of more efficient inhalation drug delivery devices could reduce the drug development time and accelerate the availability of new drugs (e.g. small molecule and biological vaccination). Furthermore, some of the proposed treatment for SARS-CoV-2 infection are re-purposed drugs that are not available in nebulised formulation, although inhalation is a rapid drug delivery technique in intensive care units (ICUs), limiting their benefits and impact.

Pharmaceutical companies often rely on the protection of the delivery device for re-purposing these drugs. However, the patents of current technologies are expiring. The patented technology provides pharmaceutical companies with a platform to protect these re-purposed formulations. The technology accelerates the availability of drugs as novel treatment for acute SARS-CoV-2 infections as well as for alleviating long term chronic outcomes, following COVID-19 disease.

Technology Overview

Effective inhalation drug delivery is crucially dependent upon the aerosol droplet size to be smaller than 5 micrometers. Nebu-Flow’s patented nebuliser technology provides a highly innovative methodology to control aerosol droplet size and flow with the potential to provide precision pulmonary drug delivery with reduced times. By creating unique acoustic wave patterns, researchers generate mechanical deformations that nebulise liquids. By coupling these into a disposable, readily-manufacturable array, they provide:

• Unique methods to control droplet size within the clinically effective range (>90% smaller than 5 micrometers)
• The ability to nebulise a wider range of therapeutics including existing drugs and emerging “high-value” biologics, which will be critically important in new vaccines and treatments; and especially for COVID-19

The SAW technology, uniquely couples the sound waves into a thin, disposable, microstructured array (termed a ‘superstrate’) containing the liquid to be nebulised. This has enabled us to have precise control over the aerosol droplet size. This ability is important as it reduces waste and enables fine tuning of drug delivery to different regions of the lung for different disease indications and different drugs.

The technology allows us to create small, low-power, silent devices, which concentrate the energy at the surface. The large physical confinement features enable easy cleaning and avoids blockage either by drug residues or suspension formulations. The technology can therefore deliver the hard-to-nebulise formulations that suffer in existing nebulisers including biologics, suspension and formulations with surface-active molecules. The technique results in ‘soft’ nebulisation that can also deliver biologics with no impact on their activity. 

Stage of Development

The technology is developed at The University of Glasgow and successfully validated with leading companies in the field. They have shown the ability of the technology to deliver a wide range of formulatons, including those with low surface tension, suspension and biologics while achieving a high fine particle fraction and mass median diameter <3µm. The technology is validated with cascade impaction (industry standard technique), for delivery of drugs such as Salbutamol, Amikacin and Tobramycin. A prototype is developed with technology readiness level of 5/6.

Benefits

Current nebuliser technologies in the market include ultrasonic, jet and mesh nebulisers. Despite advances in current nebuliser technologies (including both jet and mesh systems), current state-of-the-art devices still suffering from:

• A limited range of acceptable formulation properties
• Inefficient delivery (often <60% effective). Patients usually complain about the lack of portability of these devices which can often be noisy, require lots of cleaning and have limited ability to deliver different drugs. This usually results in patients having different devices for different drugs.

Nebu-Flow’s patented technologies have the proven ability to overcome these limitations, creating an innovative platform to enable the precise control of the generation of a wide range of different drug formulations from a disposable cartridge/reservoir.

The nebuliser device is a user friendly, silent device that employs microstructures in range of 100s of micrometers, reducing the cleaning requirements, compared to few micrometers in current mesh nebulisers. The technology can deliver a wide range of formulations, provide patients with a single platform for different drugs.

Furthermore, the platform provides the opportunity to control aerosol droplet size, increasing the fine particle fraction and lung deposition. Researchers can generate a high concentration of fine particles, highly desirable for in-vivo animal study of new formulations.

Applications

Nebu~Flow is a start-up company commercialising an aerosol delivery platform technology, with a wide range of potential applications including spray drying, formulation and specialist coatings to pulmonary drug delivery.

In the first application, researchers are exploring the technology’s potential to more effectively deliver medicines, including marketed formulations and novel high value therapeutics such as biologics, nanomedicines and vaccines, into the lungs.

Acu-Flow’s nebuliser device can reach both the $900m nebuliser market as a standalone device for delivery of available formulations and the $40bn respiratory drug market to deliver new formulations. Additionally, the new technology can be licensed to be used in combination with respiratory care devices in hospital settings.

Main users of nebulisers are people from different respiratory disorders including 100k people with cystic fibrosis and 200m with chronic obstructive pulmonary disorders (COPD). Inhalation route can also be used for systemic drug delivery. Lungs provide a large surface area for adsorption of the drug to the blood stream, bypass the first metabolism, and be used for treatment of cardiovascular and central nerve system disorders. Researchers can also adopt the technology for other drug delivery applications such as nasal drug delivery.

IP Status

• Patent is granted in Europe (EP3218033) and pending in other territories (WO2016075209A1).
• Further IPs have been developed and are being field.

Opportunity

Nebu~Flow is developing its nebuliser device and interested in building relations around co-development agreement for development of the product or partnership agreements for development of drug-device products.

Find out more

For more information on this technology, contact Darian Brookes