Nicotine Polacrilex USP/EP

Nicotine bound to a polacrilin ion-exchange resin. When the resin contacts saliva, nicotine releases through pH-dependent ion exchange — the delivery mechanism used in nicotine gum and most NRT lozenge products.

Specifications

• Grades: 10% and 20% nicotine content (bound to resin)
• Form: Fine powder (controlled particle size distribution)
• Release mechanism: pH-dependent ion exchange in the oral cavity
• Compliance: USP and EP monograph specifications
• Packaging: 1kg, 5kg, 10kg, 25kg, 50kg. Moisture-resistant packaging under nitrogen.

Applications

Nicotine gum — Polacrilex is incorporated into gum bases where nicotine releases during chewing through ion exchange with saliva. Release rate is controlled by resin loading, particle size, and gum base formulation.

Lozenges — Compressed into tablets that deliver sustained nicotine as they dissolve. Consistent release curves across production batches due to the resin's controlled-release properties.

Novel oral NRT formats — The ion-exchange mechanism can be adapted to other oral delivery systems where controlled, sustained nicotine release is required.

Regulatory

Polacrilex has an established regulatory pathway. Both USP and EP monographs define specifications for identity, assay, particle size, and release testing. Our material is manufactured and tested against both monographs, with documentation structured for FDA and EMA submissions.

Documentation

• COA with nicotine assay, particle size distribution, and release profile data
• USP/EP compliance documentation
• MSDS and TDS
• Batch traceability records