Gastric/Enteric-Soluble Pharmaceutical Film Coating
METHACRYLIC ACID-ETHYLACRYLATE COPOLYMER DISPERSION
This product is an aqueous dispersion of an anionic copolymer based on methacrylic acid units. It is equivalent to the Methacrylic Acid- Ethyl Acylate Copolymer Dispersion specified in the United States Pharmacopeia (USP), and Methacrylic Acid - Ethyl Acylate Copolymer (1:1) Dispersion 30 per cent specified in the European Pharmacopoeia (EP). It is insoluble in gastric fluid but forms salts in the presence of alkali and is soluble in weakly alkaline solutions, thereby providing an enteric coating suitable for media with a pH of 5.5 or higher.


Product Characteristics
Appearance
Milky-white, low-viscosity dispersion
Odor
Faint, characteristic odor
Content
28.5%–31.5% (dry matter)
Acid value
300–330
pH value
2.0–3.0
Viscosity
3–10 mPa·s (20°C)
Shelf life
12 months


Film-forming properties
Forms a colorless, transparent film when a plasticizer is added. The film is insoluble in media with a pH below 5.0 but dissolves in buffer solutions with a pH above 5.5.


Product Applications
  • Used for enteric film coating of pellets, tablets, and granules; suitable for colorless, transparent, or colored enteric coating formulations (e.g., for omeprazole, rabeprazole, pantoprazole, diclofenac sodium, etc.)
  • Increased coating weight enables delayed drug release in the intestinal tract.
  • Used for coating capsules and granules.

  • Packaging

    HDPE drums, 25kg per drum


    Storage
    Store in a tightly sealed container at 5 - 25°C ; protect from freezing

    返回顶部