Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Intellipharmaceutics' program to develop and manufacture drugs incorporating abuse-deterrent characteristics has advanced to next level. The company advised that it has taken delivery of and fully qualified its primary manufacturing equipment for the manufacture of an abuse-deterrent formulation of controlled-release oxycodone hydrochloride, and that the manufacture of clinical batches using that equipment has commenced.
Subscribe to our email newsletter
Intellipharmaceutics said that the successful manufacture of clinical batches is required to make the drug eligible for Phase I studies and to establish a clinical program in cooperation with the FDA in order to facilitate advancement of the drug through the application process.
Intellipharmaceutics said that the drug delivery platform, Rexista, produces a dosage form designed to be deterrent to the well-documented abuses associated with currently marketed oxycodone products, such as the abuse of these drugs by nasal inhalation when crushed or powdered, and by injection when combined with solvents. Rexista products are also designed to deter release of the entire dose when consumed with alcohol, a problem with some opioid drugs.
Isa Odidi, CEO of Intellipharmaceutics, said: “The qualification of this equipment involved the very difficult design and modification of certain aspects of the equipment to accommodate the new and proprietary dosage form which we have developed for our Rexista drug program, namely a paste in a capsule.
“We have now commenced the manufacture of clinical batches of our oxycodone CR product using this new delivery platform.”