The deal aims to solve a number of issues that blight current inhaled medication, such as formulation performance as a result of delivered dose, dose content uniformity, dose-to-dose variation, and shelf life.
Under the aims of the product co-development and licensing agreement, Prosonix’ particle engineering technology is to be coupled with Trimel’s TriVair device – a technology that delivers drug compounds through pulmonary inhalation and nasal dispersion systems that utilise unique dosing technologies.
The deal comes after Trimel’s acquisition of Danish drug delivery company, Direct Haler and its proprietary technology in December 2009. Trimel’s purchase was intended to support its developing speciality pharmaceutical business based around novel localised delivery technologies.
David Hipkiss, CEO of Prosonix, told in-PharmaTechnologist: “It was clear us at that time that the Direct Haler device would need highly engineered particles to work to the best of its potential. However, Direct Haler needed a partner to take the novel concept forward.
“By engineering and designing particles for purpose, you’ll end up with a better medicine. Also many drug delivery devices are inherently and overtly complicated as a result of trying to manage poorly performing particles resultant from their milling heritage,” he added.
Milling is considered the root cause of almost all current formulation challenges in inhalation. An absence of better, more efficient technologies has resulted in jet milling becoming the industry norm in industrial-scale drug formulation manufacturing.
Whilst jet milling can grind a friable or crystalline material to a definable micron particle size, it can also result in delivering amorphous content, instability, dose to dose variation, dose content issues, poor shelf life, and from a biological perspective, a likely dose to dose variance in pharmacokinetics.
Particle characteristics
Delivering pharmaceuticals for respiratory disorders requires the therapeutic to pass deep into the lungs. For those who suffer from asthma, cystic fibrosis and even lung cancer, particle size for inhaled medicines is crucial in delivering an improved drug performance.
Furthermore, it is important that particles are prepared so when released from the inhaler they are delivered directly into the lung. In some instances the particles can be swallowed after falling into the mouth or onto the tongue.
“We can use engineered particles in combination with the simplest of devices to achieve similar performance to those formulations marketed in costly complicated devices”, said Hipkiss.
“Then there is a very good chance we can deliver cost effective long term respiratory therapy to the emerging markets.”
Prosonix is presently working with more than twelve different originator companies in the respiratory space and has programs concerning some 16 different active pharmaceutical ingredients (API).
Additionally, Prosonix’s activity has garnered interest from a number of generic franchises who are attempting to develop generic inhalation products.