Gastric/Enteric-Soluble Pharmaceutical Film Coating
METHACRYLIC ACID-METHYL METHACRYLATE COPOLYMER (1:1)
This product is an anionic copolymer of methacrylic acid and methyl methacrylate. It corresponds to the "Methacrylic Acid and Methyl Methacrylate Copolymer (1:1)" monograph in the United States Pharmacopeia (USP). It forms salts in the presence of alkali and is soluble in neutral to weakly alkaline media, thereby providing an enteric coating that dissolves in intestinal fluid at pH 6.0 and above.


Product Characteristics

Appearance
White, free-flowing powder
Odor
Faint, characteristic odor
Content
46.0%–50.6%
Viscosity
50–200 mPa·s (20℃)
Solvent
Ethanol, isopropanol, acetone, with a small amount of water
Shelf life
24 months


Film-forming properties
Films formed from methacrylic acid- methyl methacrylate copolymer are colorless and transparent. With the addition of plasticizers to reduce brittleness, the film is insoluble in water, buffer solutions with a pH below 6.0, and natural or simulated gastric fluid (SGF)s; it is soluble in neutral to weakly alkaline media and in digestive tract conditions with a pH above 6.0.


Product Applications
Coating for tablets, granules, and pills:
  • Moisture and light protection; maintains drug stability in tropical climates
  • Gastric acid resistance; delays release until the drug reaches the intestine
  • Isolates porous or hygroscopic tablet cores
  • Isolotes incompatible ingredients
  • Granulation; serves as a matrix material
  • Increases coating weight to retard drug release

  • Packaging

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


    Storage
    Store in a sealed container at room temperature

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