The company has patented a formulation technology that blocks API uptake if too many tablets are swallowed, while other abuse deterrence formulas on the market concentrate on stopping patients tampering with drugs for snorting or injecting.
Isa Odidi, CEO of Intellipharmaceutics, told in-Pharmatechnologist.com he has found the “holy grail” of drug delivery formulations, and the technology is reminiscent of “James Bond films.”
“If you take the prescribed amount of medicine – such as one tablet – there’s no problem. But if you take two or more, it completely shuts down, and an insignificant amount of the drug is released. You could have zero release in 24 hours.”
Odidi described the technology as “paradoxical” – “the more you take the less [API is released] – you could take 10, 20, 30 or a hundred tablets [and be safe].”
The platform – PODRAS, or Paradoxical OverDose Resistance Activating System - is adjustable to accommodate regimens of various tablet dosages per day.
Intellipharmaceuticals would not share details of PODRAS’s mechanism with Outsourcing-Pharma.com, saying it is waiting until its patent is published next year.
The company is currently applying the tech to its own series of branded narcotics, including product candidate Rexista, an oxycodone hydrochloride extended-release tablet. It also plans to license out the platform.
Intellipharmaceuticals told us the technology is applicable to any solid oral dose format, including granules, beads, tablets and capsules. Its wide application means “it doesn’t make sense to give the platform to just one company,” said Odidi, who envisaged licensing the formulation to many companies on an “as-needed basis.” But “some companies might get exclusivity depending on how much they pay for it,” he added.
As well as opioids and other euphoria-producing drugs, the tech is a good fit for any drug categories where accidental overdose risks organ damage, said Odidi. This includes sleeping pills, anticoagulants and anti-diuretics (overdose can cause blood pressure to crash).
The formulation also incorporates standard abuse-deterrent properties, such as becoming “gooey” when crushed so it cannot dissolve, and a “kill-switch in the system” when the drug is mixed with alcohol. It also cannot be melted on a spoon for injection. “If you try to chase the dragon, it combusts in a few seconds and will burn your face.”
Protecting children and elderly
Odidi said the technology could change the landscape of drug-taking.
“It will allow patients to be more compliant, particularly for the elderly and other patients who might forget what they’ve taken.
“It will protect people who want to take it with wine when they shouldn’t. It will also protect households with kids where medicine is left on the table.”
The CEO added the formulation would help suicide prevention, stopping overdoses and allowing a chance for intervention.
But the original motivation for developing the tech was preventing users from getting dangerously high. Many opioid products are combined in pills with paracetamol (acetaminophen), making them dangerously toxic when taken only slightly over recommended levels.
Guidance published by the US Food and Drug Administration in January 2013 found the most common method of abusing opioid analgesics is “swallowing a number of intact pills or tablets to achieve a feeling of euphoria" and not manipulating tablets via crushing, snorting or injecting.
“Why is this happening?” said Odidi. “Taking Oxycodone etc. is an expensive habit. Those who do that are wealthy – they don’t want the stigma of crushing or snorting or injecting – they’ll do what’s easy. You can tell your spouse or classmate you’re just taking Tylenol and no one knows what’s going on.”