US cos apply imaging to nasal spray development
The first company, ChemImage, has developed an imaging system known as Falcon II which can be used to obtain detailed chemical images of material morphology, composition, structure, size and concentration in nasal sprays.
The second, Next Breath, is a CRO specialising in in vitro bioequivalence testing for nasal sprays and chemistry, manufacturing and controls (CMC) testing for inhalation and nasal spray products.
Falcon II can be used to distinguish active pharmaceutical ingredients in formulated products and discriminate between particles of API and those of an excipient or a surfactant. It can count and measure API particles, and confirm particle identity using Raman spectroscopy, according to ChemImage.
ChemImage has been actively promoting use of the Falcon II to CROs and pharmaceutical companies, either through purchase of the technology or outsourcing to its in-house lab services, so a formal alliance with Next Breath represents a logical next step.
Among Next Breath’s near-term goals is to find a faster and reproducible method for drug-particle sizing relative to bioequivalence studies, to help generics companies bring nasal spray products faster.
The companies are working on validation testing of the Falcon II system in bioequivalence testing of nasal spray products and expects to complete the work in 2010.
Ryan Priore, Senior Scientist, ChemImage, said: "Pharmaceutical companies, particularly generic drug manufacturers focused on nasal spray suspensions, are looking to improve their time-to-market through the use of better imaging technology/”
“The potential payoff is a faster, more accurate and safe way to bring the drug to market."
