EUDRAGIT® L 100-55

EUDRAGIT^® L 100-55 contains an anionic copolymer based on methacrylic acid and ethyl acrylate.

Physical properties: It is a solid substance in form of a white powder with a faint characteristic odour.

Chemical structure:

Product Form: Powder
Targeted Drug Release Area: duodenum
Dissolution: above pH 5.5

Characteristics:

• Effective and stable enteric coatings with a fast dissolution in the upper Bowel
• Granulation of drug substances in powder form for controlled release 
• Site specific drug delivery in intestine by combination with EUDRAGIT^® S grades
• Variable release profiles

CAS number: 25212 – 88 – 8
Chemical/IUPAC name: Poly(methacylic acid-co-ethyl acrylate) 1:1
INCI name: Acrylates Copolymer

Monographs:

        Ph. Eur.: Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A
        USP/NF: Methacrylic Acid Copolymer, Type C - NF
        JPE: Dried Methacrylic Acid Copolymer LD

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

Drug Master File: # 2584
Weight average molar mass: approx. 320,000 g/mol
Acid Value: 315 mg KOH/g polymer
Glass Transition Temperature (Tg): ~110°C


An according EIP format is available on request.