Effect of manufacturing process on the retention of abuse-deterrent properties of PEO-matrix tablets

Prescription drug abuse/ misuse continues to be a growing global health concern. There have been various approaches used to decrease the risk of prescription drug abuse, and the development of abuse-deterrent formulations is one of the strategies being used by the pharmaceutical industry to limit the abuse of opioids and stimulant products. Polyethylene oxide can be included in tablets, and when tablets are heated, the polymer forms an extremely hard, plastic-like matrix. This makes the tablets more resistant to breaking and powdering and extracting the drug by crushing or grinding the tablets will be more difficult. However, the abuse-deterrent tablets are still able to be broken into smaller pieces, results have shown that amount of drug after grinding the tablets in finer particles is still pretty high even though the number of small particles is less than before.

In this research, several different tablet-making processes were evaluated to reduce formation of small particles following crushing or grinding in order to make the drug products abuse less satisfying and rewarding for abusers. The best method to accomplish this goal was shown to be hot-melt extrusion which produced granules with uniform distribution of drug that did not break into smaller pieces when subject to typical tampering methods.