ABSTRACT

Introduction: Many abuse-deterrent formulations (ADFs) rely on being crush resistant and extraction resistant in order to provide deterrence to abuse by insufflation and injection, respectively. High molecular weight polymers such as poly(ethylene oxide) are commonly used to provide this deterrence. However, these polymers suffer from slow dissolution kinetics, and are susceptible to variety of abuse conditions.

Objective: This study was aimed to determine if selected superabsorbent polymers (SAPs) could be used as a suitable alternative to thwart extraction, filtration, and syringeability attempts for abuse.

Methods: Several commercially available SAPs were evaluated for swelling behavior in extraction solvents, and tableting properties. Post-compaction abuse properties were evaluated by recoverable volume and syringeability after solvent extraction. Drug release and percent drug extraction were conducted using tramadol HCl as a model drug.

Results: Certain SAPs had the ability to rapidly imbibe solvent and effectively stop extraction processes in a variety of solvents, including water and water/alcohol mixtures. Tablets containing SAP and drug showed no effect on drug release in vitro.

Conclusions: SAPs possess adequate properties for tableting, and maintain their high and fast swelling properties after compaction. The fast and extensive interactions of SAPs with aqueous medium are a major advantage over non-crosslinked high molecular weight viscosifying agents such as poly(ethylene oxide).

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