Lucideon, the international materials consultancy, has announced that it has launched iCRT-deter, a new delivery platform technology that provides abuse deterrent controlled release for pharmaceutical applications.
With release rates that can be tailored from one to two hours to over a period of days in different environments and media, iCRT-deter has a number of unique characteristics that help deter abuse of a drug through careful control of the microstructure. These include an extremely hard silicon structure that, unlike traditional polymer systems, is very hard to crush beyond its primarily particle size, and particulate technology that allows individual particles to retain their properties even when crushed from a tablet back down to the powder. With regards to abuse by injection, low solubility and large particle sizes that are inherent to the technology make products unsuitable for injection through suspension. An extremely high melting point will also deter injection as melting the carrier will destroy the drug.
Gemma Budd, healthcare business manager, said: “With the increasing occurrence of prescription drug abuse and the probability of even stricter regulations around the approval of extended release opioids and other addictive/highly potent compounds, we saw a challenge ahead for our customers. We saw real potential in our inorganic controlled release platform for abuse deterrence, and consider it a completely different approach to other alternatives being developed.
“We’re already working with a number of industry partners to commercialise our iCRT technology, and are keen to hear from other pharma companies who are interested in iCRT-deter.”
iCRT-deter materials are Generally Recognised As Safe (GRAS) by the FDA and Lucideon has an independent toxicology report stating the materials are safe for ingestion at much higher concentrations than will ever be used. In vivo, bioequivalence studies are expected to be completed by June 2015.
In addition, production is a green process in that it is not energy intensive, with most of the process performed at room temperature. There are no organic solvents or toxic by-products used during manufacture.
