Nicotine Polacrilex/Resinate USP/EP

Nicotine Polacrilex/Resinate USP/EP is a specialized form of nicotine designed for use in nicotine replacement therapy (NRT) products. This compound combines nicotine with an ion-exchange resin, creating a complex that controls the release of nicotine into the body. This controlled release helps in reducing withdrawal symptoms and cravings associated with quitting smoking.

Chemical Composition and Structure

Nicotine Polacrilex is formed by binding nicotine to a polymeric resin. The ion-exchange resin typically used is polymethacrylic acid. The nicotine molecule is held within the resin through ionic interactions, allowing for a gradual release as it is ingested and processed by the body.

  • Chemical Formula: (C₁₀H₁₄N₂)n • (C₅H₈O₂)m
  • Molecular Weight: Variable depending on the resin and the amount of nicotine bound.
  • Appearance: White to off-white powder or granules.
Mechanism of Action

When Nicotine Polacrilex is used in products like nicotine gum, lozenges, or patches, the resin slowly releases nicotine as it comes into contact with saliva or skin moisture. This slow release mimics the nicotine absorption pattern seen in smoking, helping to reduce withdrawal symptoms and the urge to smoke.

Applications

Nicotine Polacrilex is primarily used in:

  1. Nicotine Gum: Chewing the gum releases nicotine gradually, providing relief from cravings and withdrawal symptoms.
  2. Nicotine Lozenges: Dissolving lozenges in the mouth releases nicotine over a period.
  3. Nicotine Patches: Transdermal patches utilize the compound to release nicotine through the skin over several hours.
Specifications
  • Purity: ≥ 98%
  • Nicotine Content: Typically around 4 mg per piece for gum and lozenges, variable for patches.
  • Solubility: Insoluble in water; designed for controlled release in biological fluids.
Quality Standards

Nicotine Polacrilex/Resinate meets the United States Pharmacopeia (USP) and European Pharmacopoeia (EP) standards. These stringent standards ensure the product’s safety, efficacy, and consistency.

  • USP Specifications:

    • Identification: Passes test
    • Assay: 97.0% – 103.0%
    • Related Substances: ≤ 0.5%
    • Residual Solvents: Meets requirements

  • EP Specifications:

    • Identification: Passes test
    • Assay: 97.0% – 103.0%
    • Related Substances: ≤ 0.5%
    • Residual Solvents: Meets requirements
Manufacturing Process

The production of Nicotine Polacrilex involves several steps:

  1. Resin Preparation: The ion-exchange resin is synthesized and purified.
  2. Nicotine Binding: Nicotine is adsorbed onto the resin under controlled conditions.
  3. Drying and Processing: The resulting complex is dried and processed into the desired form (e.g., powder, granules).
  4. Quality Control: Each batch undergoes rigorous testing to ensure it meets USP/EP standards.
Benefits
  • Controlled Nicotine Release: Mimics the nicotine absorption pattern of smoking, aiding in smoking cessation.
  • Reduced Side Effects: Gradual release minimizes the risk of nicotine overdose and associated side effects.
  • Versatile Applications: Suitable for various NRT products, including gum, lozenges, and patches.
Safety and Handling

Nicotine Polacrilex should be handled with care due to nicotine’s toxic nature. Protective equipment such as gloves and masks should be used when handling the raw material. The product should be stored in a cool, dry place away from direct sunlight and moisture.