An extremely hard silicon structure is very difficult to crush without special grinding equipment
Lucideon’s iCRT-deter is a new oral drug delivery technology that provides abuse deterrent controlled release.
With release rates that can be tailored from one to two hours to over a period of days, the international materials technology company says iCRT-deter has a number of characteristics that help deter drug abuse. These include an extremely hard silicon structure that, unlike traditional polymers, is very difficult to crush without special grinding equipment, 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 make products unsuitable for injection through suspension. A high melting point will also deter injection because melting the carrier will destroy the drug.
A coating can also be added to the formulated product to add extra protection and increase the control over release times. Aversive agents can be added if the coating is broken to aid tamper deterrence, including unpleasant tastes to deter oral consumption after the tablet is broken, waxy additives to stick crushed powder, making nasal inhalation difficult, and colour leeching in liquids, to deter spiking of drinks.
Gemma Budd, Lucideon’s 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.
‘With more than 60 years experience of working with inorganic materials for controlled release applications, and with proprietary systems already commercialised for some applications, and consider it a completely different approach to other alternatives being developed.’
iCRT-deter materials are Generally Recognised As Safe (GRAS) by the US FDA and Lucideon has an independent toxicology report stating that the materials are safe for ingestion at higher concentrations than will ever be used. In vivo, bioequivalence studies are expected to be completed by June.