Gastric/Enteric-Soluble Pharmaceutical Film Coating
METHACRYLIC ACID-METHYL METHACRYLATE COPOLYMER (1:2)
This product is an anionic copolymer of methacrylic acid and methyl methacrylate. It corresponds to the "Methacrylic Acid and Methyl Methacrylate Copolymer (1:2)" monograph in the United States Pharmacopeia (USP). It forms salts upon contact with alkali and is soluble in neutral to weakly alkaline media, thereby providing an enteric coating that dissolves in intestinal fluid at pH 7.0 and above.


Product Characteristics
Appearance
White, free-flowing powder
Odor
Faint, characteristic odor
Acid value
210–240
Content
27.6%–30.7%
Viscosity
50–200 mPa·s (20℃)
Solvent
Ethanol, isopropanol, acetone, with a small amount of water
Shelf life
24 months

Film-forming properties
Films made from methacrylic acid- methyl methacrylate copolymer (1:2) are colorless and transparent. With the addition of plasticizers to reduce brittleness, the film is insoluble in water, buffer solutions with a pH below 7.0, and natural or simulated gastric fluid (SGF)s; it is soluble in neutral to weakly alkaline media and in the digestive tract at pH 7.0 and above.


Product Applications
Coating for tablets, granules, and pellets:
  • Moisture and light protection; maintains drug stability in tropical climates
  • Gastric acid resistance; enables release at pH 6.0–6.8 when combined with methacrylic acid- methyl methacrylate copolymer (1:1)
  • Gastric acid resistance; delays release until the colon
  • Isolation of incompatible ingredients
  • Enhances drug stability; extends the shelf life of pellets, powders, and granules
  • Granulation; serves as a matrix- forming material
  • Increases coating weight to retard drug release

  • Packaging

    Fiber drums lined with double- layer polyethylene bags; 10 kg per drum


    Storage
    Store in a sealed container at room temperature

    返回顶部