Grants for a patent describing an innovative method to improve particle size analysis methods by laser diffraction have been announced by Hovione Technology Ltd, the Irish-based medical device arm of Hovione, the international company with over 60 years of experience as a Pharma CDMO.
The patent, covering a method that solves a decades-old problem in ensuring machine-to-machine test result reproducibility has been granted or allowed in the USA, Europe, Japan and China and relies on a deep understanding of the process to deagglomerate powder particles prior to laser diffraction analysis, itself a precise technique but dependent on correct sample preparation. Hovione scientists discovered that through time, deagglomeration techniques lose efficacy through equipment wear and developed a method that precisely compensates for that wear, thus preparing an ideal sample for every particle size test. This is particularly important in drugs with a particle size less than 10 micron or which tend to agglomerate.
“For years we had problems where the same batch of powder gave different results when tested in different laser diffraction testing machines and this led to serious issues and challenges during method transfer. Drugs known to agglomerate, particularly fine powders used for inhaled pulmonary delivery, were a problem to test. We have implemented the improved method in different machines of different analytical laboratories and everyone is now getting the same test data”, said Constança Cacela, Director of Analytical Development. at Hovione.
“We saw the IP potential of Hovione’s invention and went ahead with patent filing and prosecution. Even though our application went through vigorous scrutiny and an objection from a third party, it has now proceeded to grant in all jurisdictions where it was filed”, said Peter Villax, CEO of Hovione Technology. “These patents are now being offered for licensing to several manufacturers of laser diffraction particle sizing machines and they could have an impact on this market”, he concluded.
Hovione was founded in 1959 and employs 2000 team members in Portugal, USA, Ireland and Macau. It is a fully integrated supplier offering development and manufacturing services for drug substance, drug product intermediate and drug product, and is a specialist in inhalation-grade products delivered to the lung.
Hovione Technology is dedicated to the development, patenting and licensing of pulmonary delivery technology and dry-powder inhalers, currently offering a portfolio of five inhaler devices. It is the patent holder of TwinCaps®, the world’s largest selling single-dose, factory filled dry-powder inhaler, and PowdAir Plus, the new market approved capsule DPI for asthma and COPD management. Millions of patients are treated every year with Hovione Technology’s innovative inhaler technology.
