1/ Introduction
Methacrylic acid & methyl methacrylate co-polymer is an enteric film-coating excipient widely used in pharmaceutical research and manufacturing. This polymer dissolves at pH > 5.5, thereby enabling drug release in the duodenum or small intestine. It is freely soluble in alcohol, methanol, isopropyl alcohol, and acetone; insoluble but well dispersible in water. It is available in two grades:
- L100: powder form, white to slightly yellowish in color
- L30D: 30% ready-to-use aqueous dispersion
2/ Key Advantages
- Readily soluble at pH > 5.5, suitable for active ingredients requiring release in the duodenum and small intestine, while avoiding gastric irritation or degradation.
- L100: powder form, readily soluble in alcohol, uniformly dispersible in water, convenient for preparing coating solutions, and allows easy formulation adjustments
- L30D: ready-to-use aqueous dispersion, simplifies formulation and manufacturing processes; free from organic solvents, thereby minimizing the risk of residual solvents
- More resistant to hydrolysis compared to some other ester polymers (e.g., cellulose acetate phthalate – CAP).
- Good stability under storage conditions; not easily oxidized or degraded in neutral environments.
- Forms mechanically strong films, resistant to cracking or peeling when used with suitable plasticizers (e.g., triethyl citrate, PEG).
- Produces glossy films with controllable thickness, contributing to consistent dissolution profiles.
- Product complies with USP/EP/BP
- The manufacturer has EXCIPACT GMP Certificate for Pharma application
- Stock available at GSP/ GDP warehouse, prompt delivery, competitive price
3/ Applications
- APIs unstable and easily hydrolyzed in acidic environments (e.g., erythromycin, proton pump inhibitors – PPIs).
- APIs that irritate the stomach (e.g., aspirin).
- Drugs targeted for release in the intestine, used in the treatment of intestinal diseases.
- Enzymes (e.g., pancreatin).
4/ Commercial Products
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