Gastric/Enteric-Soluble Pharmaceutical Film Coating
AMINO METHACRYLATE COPOLYMER
This product is a cationic acrylate copolymer, equivalent to the "Amino Methacrylate Copolymer" specified in the United States Pharmacopeia (USP). It dissolves by forming salts upon contact with acid. The film coating formed by this product is soluble in gastric fluid and acidic media with a pH below 5.0, but insoluble in neutral to weakly alkaline media; it offers superior moisture resistance compared to HPMC.


Product Characteristics
Appearance
Pale yellow granules or off-white powder
Odor
Amine-like odor
Content
20.8%-25.5%
Viscosity
3-6 mPa·s (20℃)
Solvent
Ethanol, isopropanol, or acetone
Shelf life
24 months


Film-forming properties

The film formed is colorless, transparent, flexible, and elastic. It is readily soluble in acids (such as natural or simulated gastric fluid) and in buffer solutions with a pH of 5.0 or lower, it swells and becomes permeable in water or buffer solutions with a pH above 5.0.


Product Applications
Tablets and sugar- coated pills:
  • Prevent abrasion and dusting
  • Enhance product stability
  • Mask unpleasant odors
  • Provide a barrier against moisture, light, and air
  • Improve product appearance or color
  • Capsules:
  • Provide effective sealing
  • Enhance product stability
  • Pills, granules, and powders:
  • Isolates incompatible ingredients
  • Improve drug stability and extend shelf life

  • Packaging

    Fiber drums with double- layer polyethylene inner liners; 10kg or 20kg per drum


    Storage
    Keep sealed; store at room temperature.

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