Prosonix’s SonoLab is seen as working well in conjunction with Syrris’ Atlas synthesis system, providing customers with a platform for ultrasonic experimentation and transition from laboratory to pilot plant, at scales from 100ml to 100L.
SonoLab uses Prosonix’s proprietary sonocrystallisation technology to control the crystal particle size of an active pharmaceutical ingredient (API), without the need to operate at high supersaturation or use external seeds.
Mark Gilligan, Syrris CEO said: “Prosonix’ suite of particle engineering technologies represent a potential ideal solution to a range of manufacturing and formulation problems that are directly related to the historic methods of crystallising APIs, currently commonly employed throughout the pharmaceutical industry.
“This new partnership is an ideal and further differentiation for Syrris global product offering in automated reactor platforms.”
The crystal size of an API affects its dissolution rate in a biological system, an important consideration when 40 per cent of new molecules are poorly water soluble.
In addition 1-5µm sized particles are needed for a drug to be pulmonary administered, an increasingly attractive delivery method for ailments including asthma, cystic fibrosis and diabetes.
Prosonix’s sonocrystallisation technology, called Complete Crystallization Control by the company, uses ultrasound to manipulate API formation.
Ultrasound vibration causes cavitation, which are the transient high-energy microbubbles formed when a liquid medium has 20-100 kHz acoustic frequencies applied to it. This causes the release of energy, which can result in permanent changes in the molecular structure of nearby entities.
Alternative methods for the preparation of mesoscopic particles are known as size reduction, or "top-down," destructive methods. These techniques use large quantities of energy that can damage the crystals surface, creating highly charged and cohesive particles.
This can result in chemically and physically unstable particles, which can undergo undesirable surface polymorphological transformations and be unsuitable for inhaled applications.
Consequently, “bottom-up” techniques such as sonocrystallisation are more inline with the US Food and Drug Administration’s (FDA) quality-by-design initiative, which aims to use technologies to improve product quality.
From lab to commercial scale
Syrris’ Atlas platform is an automated laboratory reactor suite, which has an ergonomic design, modularity, innate simplicity, reliability and intelligent intuitive software, according to the company.
By offering Atlas with SonoLab and Prosonix’s Prosonitron technology, which applies Complete Crystallization Control to commercial scale manufacturing, the companies believe they offer a complete suite.
SonoLab uses the same bonded transducer based design found in Prosonitron reactors, which is already used in commercial scale operations in good manufacturing practice (GMP) environments for primary and secondary API production.
Prosonitron is being installed at Pfizer’s manufacturing facilities in Ireland. The marketing agreement is seen as a method of making the technology more accessible to pharmaceutical companies, paving the way for similar deals for SonoLab.
David Hipkiss, Prosonix CEO, said: “I am delighted to be able to announce this partnership with Syrris, the rapidly emerging leader in automated laboratory reactors.
“It provides Prosonix’ global pharmaceutical customers a highly focused and cost effective means of accessing our process technology at small scale. We look forward to working with Syrris in the months and years ahead.”