Gastric/Enteric-Soluble Pharmaceutical Film Coating
POLYACRYLIC RESIN II


Polyacrylic Resin II is an anionic copolymer of methacrylic acid and methyl methacrylate. By forming alkali salts, it becomes soluble in neutral to weakly alkaline media, thereby providing an enteric film coating that dissolves in intestinal fluid at a pH above 6.0.



Product Characteristics
Appearance

White, irregular granules or free-flowing powder

Odor
Faint, characteristic odor
Acid value
300–330
Solvent
Ethanol, isopropanol, acetone, with a small amounts of water
Shelf life
12 months


Film-forming properties


Films made from Polyacrylic Resin II are colorless and transparent; plasticizers are added to reduce brittleness. The resin is insoluble in water, buffer solutions with a pH below 6.0, and both natural and simulated gastric fluid. It is soluble in neutral to weakly alkaline media and in the intestinal tract where the pH above 6.0.



Product Applications
Coating for tablets and pellets:
  • Moisture and light protection; maintaining drug stability in tropical climates
  • Gastric acid resistance to delay release until reaching the intestine
  • Isolation of hygroscopic or porous tablet cores
  • Film coating for lozenges and throat pastilles
  • Coating for granules, powders, and pellets:
  • Gastric acid resistance to delay release until reaching the intestine
  • Isolation of incompatible ingredients
  • Enhancement of drug stability
  • Resin granulation; use as a matrix material
  • Sustained/delayed drug release

  • Packaging

    Carton: Lined with double- layer polyethylene bags; 20kg per carton


    Storage
    Keep sealed; store below 30°C

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