Abuse deterrent formulations for prescription drug products are designed to make manipulation more difficult or less rewarding.
While there are a variety of ADF approaches, there are three main methods for abuse deterrence in use or under nearer-term development that address different manners of abuse:
- Physico-chemical barriers (crush/chewing resistance, gelling)
- Specific ingredients and manufacturing technology make otherwise identical tablets resistant against crushing or breaking as a barrier for abuse through snorting and to an extent by chewing. When attempting to dissolve the drug for injection, these formulations turn into a gel-like mass which makes it very difficult or close to impossible to get the drug through the needle of a typical syringe. This barrier is in the “new” OxyContin and other products.
- Pharmacological barriers (opioid agonist/antagonist approach)
- Opioids work by attaching themselves to receptors in the body. By embedding other drugs -- so-called antagonists -- into the pill, the effect of the narcotic can be blocked when abused (e.g. when crushing or dissolving), while still releasing the appropriate medication when used as prescribed by the patient. This barrier is in the hydromorphone product recently approved by the FDA, Hysingla.
- Pro-drugs are products that release the active drug in the body after swallowing, typically in the digestive tract. For example, when the pill reachs the intestines, enzymes in the gut cause the release of the active ingredient as prescribed and designed. It helps prevent the rapid euphoria that abusers seek. Only one pro-drug of amphetamine is in the market which demonstrates lower rates of abuse compared to the traditional amphetamine products, stimulant products, but abuse by oral and non-oral routes is still possible.
Lastly, combinations of these, and other technologies offer the potential to increase the effectiveness of ADF inclusion in different products. Current abuse deterrent products have reduced abuse for snorting, injecting and chewing. Nothing has yet come to the market that reduces abuse by swallowing. No abuse deterrent technology provides 100% protection.