What happened to nebuliser innovation?
Wilbur de Kruijf1
1Resyca, Colosseum 23, Enschede, the Netherlands.
Resyca is a joint venture between Recipharm and Medspray.
Summary
Nebuliser innovation is ongoing, often far away from the spotlights of the inhalation pharma industry. This paper lists some of the recent innovations in liquid inhalation systems during the last five years: From smaller and smarter vibrating mesh nebulisers to aerosol dispensers for mass vaccination via inhalation. The DDL lecture gives an overview of the physics of aerosol generation principles for existing nebulisers and addresses their limitations.
Existing drug device combination products based on jet, ultrasonic and vibrating mesh nebulisers generally only serve rather small patient groups. Soft mist inhalers (SMIs) are mass produced (in double digit millions) mechanical portable ‘nebulisers’ and are in use for large patient groups like COPD.
However, more fundamental liquid inhaler system innovation will be needed to enable the delivery of biologics to the lung, especially for diseases that affect large patient populations. The novel therapies will likely require milligrams of drug, not micrograms like current asthma drugs. The first generation SMIs can only handle relatively small doses, due to the physics of their aerosol generation process. Regular nebulisers enable large drug doses, but the filling and cleaning of these devices is a burden for the patient, devices are not pocket size and the cost per treatment is high when compared to DPIs, SMIs and pMDIs.
With the upcoming wave of biological treatments, the requirements for inhalation systems are changing. Treatments may follow totally new regimen, like a single 10-day course. Handing out an electric nebuliser device to a large group of patients may not fit that well to the reimbursement of such a treatment. The author expects biologics to become a driver of liquid inhalation innovation in the coming five years.
Key Message
The author expects nebuliser innovation to surf the wave of inhaled biologics, requiring milligrams of drug delivered to the lungs. For mainstream applications for novel biologic drugs, a new class of liquid inhaler devices will need to strike the balance between usability, keeping the drug formulation intact during shelf life and nebulisation, and cost-effectiveness of the treatment.