The lung represents an excellent drug delivery target; oral inhalation of appropriate drug formulations provides direct (topical) therapy of respiratory diseases such as asthma and COPD, by relieving restricted airflow to the lungs caused by localised inflammation and constriction of the airways.

Typically respiratory medicines targeting these conditions are based on inhaled corticosteroids (ICS), which have an anti-inflammatory effect, and bronchodilators (such as β2 agonists and muscarinic antagonists/anticholinergics) that relax the muscle in the respiratory tract and increase airflow. These are currently administered as orally inhaled mono- or combination therapies in suspension or dry powder formulations, often with stabilising excipients, and via a multitude of single or multi-dose devices.

Respiratory medicines are however among the most complex drugs to develop and deliver. As a result, just a few products dominate large global markets and directly substitutable generic products face a challenging route to market.

Prosonix believes that the development of future respiratory medicines requires a radical new approach whereby the medicine is designed from the start to meet the specific criteria for oral inhalation, such as:

• Stable API, stable assured formulation and shelf-life
• Minimal or zero requirement for stabilising excipients
• Optimal effectiveness and consistency of delivered dose
• Delivery via simple-to-use and cost-effective devices, reducing treatment cost
• Tailored targeting of drug particles at will
• Enhanced co-location of two drugs in combination therapy
• Optimal therapeutic and safety profile
• Enhanced patient compliance

Increasingly regulators and drug developers recognise that the physicochemical properties of the individual drug particles (the active pharmaceutical ingredients, or APIs), such as size, morphology, surface energy, surface 3D geometry and aerodynamics, govern particle performance in orally inhaled formulations.

Prosonix has demonstrated that its ultrasonic particle engineering platform enables the exquisite control of these properties for a range of ICS, LABA and LAMA particles, which form the basis of its own development pipeline. The Company believes that this approach provides the key to unlocking the development of generic and novel respiratory medicines in the future.

Respiratory medicines are among the most complex drugs to develop and deliver…

…Increasingly regulators and drug developers recognise that the physicochemical properties of the individual drug particles govern particle performance in orally inhaled formulations.