EUDRAGIT® E 12,5

EUDRAGIT^® E 12,5 is a cationic copolymer based on dimethylaminoethyl methacrylate, butyl methacrylate, and methyl methacrylate.

Physical properties: It is a light yellow liquid of low viscosity, clear to slightly cloudy. The odour is characteristic of the solvents.

Chemical structure:

Product Form: Organic Solution 12,5%
Targeted Drug Release Area: Stomach

Dissolution:

• Soluble in gastric fluid up to pH 5.0
• Swellable and permeable above pH 5.0

Application:

• Low viscosity, high pigment binding capacity, good adhesion
• low polymer weight gain

CAS number: 24938 – 16 – 7
Chemical/ IUPAC name: Poly(butyl methacylate-co-(2-dimethylaminoethyl) methacrylate-co-methyl methacrylate) 1:2:1
INCI name: Acrylates / Dimethylaminoethyl Methacrylate Copolymer

Monographs: 

        Ph. Eur.: Basic Butylated Methacrylate Copolymer
        USP/NF: Amino Methacrylate Copolymer - NF
       JPE: N/a

GMP standard: The Joint IPEC – PQG Good Manufacturing Practice Guide for Bulk pharmaceutical Excipients 2006 and USP-NF General Chapter <1078>

Drug Master file: #1242
Weight average molar mass: approx. 47,000 g/mol
Alkali Value: 180 mg KOH/ g polymer
Glass Transition Temperature (Tg): ~ 48°C



An according EIP format is available on request.