The technology, made commercially available for the first time this month, uses a highly specialised new variant of Prosonix' sonocrystallisation technique to make active pharmaceutical ingredient (API) particles without mechanically disruptive high-energy milling or micronisation.
This approach, Hipkiss told in-Pharmatechnologist, produces crystalline particles that are free of the variability introduced by traditional physical processing methods.
“The milling process delivers amorphous unstable material, which in turn leads to significant batch to batch variation and variable drug product performance.
“Milling is notoriously difficult to scale up and preserve early stage clinical performances and the root cause of many current customer woes is the fact they have milled the API. This can kill products in late stages.”
He went on to explain that: “The ideal particles for inhalation are small, crystalline, stable and excipient free,” adding that “UMAX [ultrasound mediated amorphous to x-alline transition]… can deliver best in class performance for new products, or enable generic bioequivalence.
Limiting LABA
Hipkiss also said that UMAX particles double the dose of an API from the same mass of starting material and cited new US rules prohibiting use of long-acting beta agonists (LABA) as a monotherapy as an area of application.
“We can half the content of a LABA in a UMAX formulation compared to the original formulation yet get the same mass of LABA out of the device as comes from the original formulation resulting in a safer product.
He went to explain that UMAX’ ability to produce particles combining two or more APIs can “transform combination inhalation therapy…confirming we can deliver uniform and constant ratios of Fluticasone and Salmeterol across the lung making a safer and more syngergistic product.”
Lifecycle advantages
Hipkiss also stressed the advantages the UMAX approach can provide for drugmakers in terms of wider product life-cycle management issues.
“We work across the life cycle with many companies. The UMAX particles are in themselves unique and can be considered as a new product using existing drugs as the base point.”