Medical Device Link.

DRUG DELIVERY

ImageTherm (Sudbury, MA) is extending its technology for measuring spray pattern and plume geometry of pharmaceutical-spray drug products by more fully automating the other in vitro tests recommended by FDA. These other tests include measurements of pump delivery, dose-content uniformity, priming/repriming, and particle/ droplet size distribution, says Dino Farina, president.

“Companies want improved testing automation to increase efficiency and quality control in their effort to bring new products to market. Many companies still perform most of the testing—especially shot weighing and spray pattern—either with disparate systems that aren’t integrated, or by hand. This often results in inconsistencies and analyst repetitive-stress disorders,” says Farina.

ImageTherm’s software and hardware systems are used in every step of pharmaceutical spray testing, development, and manufacturing, improving efficiency and supply-chain management. Hardware control and data analysis are supported by client-server software based on an Oracle relational database. The software allows traceability down to the actuation level, providing users with the ability to see trends easily in the products’ performance and to perform comparative analyses for bioequivalence in generic products, Farina says.

A patented, programmable automated actuator simulates device-trained patients in a wide range of age and gender groups, following FDA and U.S. Pharmacopeia guidelines. Using automatic actuation, testing is more efficient, consistent, and relevant to actual product performance, he says.

“Basically, the more integrated your testing systems become, the faster you can see all aspects of your product’s performance and make any necessary adjustments to the product. This holistic approach can significantly improve product quality and throughput efficiency, both of which are key factors in FDA’s approval process,” says Farina.