Prosonix pushes sonocrystallisation forward
attempt to reach the inhaled drug delivery market - at the same
time the British firm has extended an agreement with UCB for the
use of its existing sonocrystallisation technology.
Prosonix, the ultrasonic process solutions provider formerly known as C3, launched its new particle engineering technology, called SAX (solution atomisation and crystallization by sonication), at last week's CPhI Pharmaceuticals trade show in Paris.
The technology is a new form of sonocrystallisation, developed over 18 months in conjunction with the University of Bath, that offers new potential in the production of smaller particles, particularly for inhaled therapeutics, David Hipkiss, CEO of Prosonix, told In-Pharmatechnologist.com.
"This technology has the ability to make combination particles directly with an inbuilt dual active pharmaceutical ingredient (API) functionality," said Hipkiss.
"Since launching the technology we have experienced spectacular interest from pharmaceutical companies - at least six of the top ten firms are very excited about the technology's potential," he said.
"We expect to have our first lisencing deal in place by the end of the year."
Drug delivery by inhalation is a significant market and one that is growing rapidly as a large proportion of new drug candidates today are water insoluble, but oil soluble, and exhibit poor bioavailability leading to abandoned development efforts.
Conventional crystallisation techniques in the processing of pharmaceutical ingredients for a number of dosage forms - including inhaled therapeutics - have limitations, in that they typically require micronisation, which is expensive and can affect a range of physicochemical properties.
As a result, there is an unmet need to engineer crystalline particles with an even greater control of their size and shape while maintaining high throughput, low cost and industrial scalability and new alternative methods of smaller drug particle production have generated significant interest, although with limited success so far.
However, sonocrystallisation - the application of power ultrasound to improve crystallisation to produce the desired particle size and distribution - has been proving valuable as it allows secondary processing techniques such as micronisation to be avoided.
Certainly UCB has identified the potential of this relatively new technology, developed by Prosonix.
The Belgian pharma firm has signed a new agreement allowing it to use Prosonix's multipurpose sonocrystallisation reactor system, Prosonitron, in its facilities in Belgium to undertake further scale up and clinical development activities following initial proof of concept and proof of process studies.
According to Hipkiss, UCB will use the technology in an attempt to control the physical form of two new lead drug products.
"The Prosonix technology has the potential to become an ideal cost effective solution to a range of common crystallisation problems associated with the manufacture of our pharmaceutical products," said John Surtees, director of chemical process R&D at UCB.
"It is simple to use and retrofit, has no moving parts, and requires no chemical additives." he added.
In addition, Prosonix claims further benefits of its technology are that it can be applied at any stage during a products lifecycle, through early laboratory studies through to full industrialisation.
