Intellipharmaceutics Introduces Technology for Abuse-Deterrent Drugs
Intellipharmaceutics International Inc., a Toronto-based pharmaceutical company specializing in the research, development, and manufacture of controlled-release and targeted-release oral solid dosage drugs, has introduced a new platform technology for abuse-deterrent drugs.
The new platform, PODRAS (Paradoxical OverDose Resistance Activating System) is designed to prevent overdose when more pills than prescribed are swallowed intact. Intellipharmaceutics’ most advanced application of the PODRAS platform to date is its drug candidate Rexista (oxycodone hydrochloride extended-release tablet), which is designed to deter abuse by both physical interference and overdose .In addition to its use with oxycodone, the new technology is potentially applicable to other drug products that are intentionally or inadvertently abused and cause harm by overdose to those who ingest them, such as other opioid drug candidates (i.e., oxymorphone, hydrocodone, and morphine).
Rexista provides deterrence against intentional (drug abuse) and unintentional dose dumping. Dose dumping is the rapid release of active ingredient from a controlled-release drug into the bloodstream that can result in increased toxicities, side effects, and a loss of efficacy. Dose dumping can result by consuming after crushing, taking with alcohol, extracting with other beverages, vaporizing, and injecting
Intellipharmaceutics International says that physico-chemical studies suggest that Rexista oxycodone: should be difficult to abuse through crushing, chewing or licking; release of oxycodone is likely to be slower or not instantaneous in a range of beverages and solvents; should not “dose dump” or instantaneously release the entire dose of oxycodone, in the presence of ethanol over a range of concentrations; when pulverized and reduced to particles, should be difficult and time consuming to syringe or inject in the form and volume suitable for intravenous administration; when pulverized or reduced to particles, should be difficult or inefficient to snort or inhale; release of oxycodone should be insignificant or inefficient via heating and vaporization; extraction of oxycodone that has been microwaved should be difficult or inefficient.
The science of abuse deterrence is relatively new, and both the formulation technologies and the analytical, clinical, and statistical methods for evaluating those technologies are evolving. In January 2013, the US Food and Drug Administration issued a draft guidance document on the evaluation and labeling of abuse-deterrent opioids. The guidance explains the FDA's current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties, how those studies will be evaluated, and what labeling claims may be approved based on the results of those studies.