EUDRAGIT® L 100

EUDRAGIT^® L 100 are anionic copolymers based on methacrylic acic and methyl methacrylate.

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: jejunum
Dissolution: Dissolution above pH 6.0

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: 25086 – 15 – 1
Chemical/IUPAC name: Poly(methacylic acid-co-methyl methacrylate) 1:1
INCI name: Acrylates Copolymer

Monographs

        Ph. Eur.: Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)
        USP/NF: Methacrylic Acid Copolymer, Type A - NF
        JPE: Methacrylic Acid Copolymer L 

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. 125,000 g/mol
Acid Value: 315 mg KOH/ g polymer
Glass Transition Temperature (Tg): >150°C

An according EIP format is available on request