EUDRAGIT® FS 30 D

EUDRAGIT^® FS 30 D, the milky-white liquid of low viscosity with a faint characteristic odor is the aqueous dispersion of an anionic copolymer based on methyl acrylate, methyl methacrylate and methacrylic acid. It is insoluble in acidic media, but dissolves by salt formation above pH 7.0. Apart from its enteric properties, its dissolution at a higher pH value allows targeted colon delivery.

With a glass transition temperature of 48°C, EUDRAGIT^® FS 30 D is a very flexible polymer. Due to the low minimum film forming temperature only small amounts of plasticizer are required to get a smooth film formation.

Physical properties: It is a milky-white liquid of low viscosity with a faint characteristic odor.

Chemical structure:

Product Form: Aqueous Dispersion 30%
Targeted Drug Release Area: Colon delivery
Dissolution: pH 7.0

Characteristics:

• A solubility above pH 7.0 allows specific colon targeting
• Because of its flexibility it is particularly suitable for multi unit dosage forms
• Matrix systems with EUDRAGIT^® FS 30 D will release 100% of the drug
• Polymer amounts of 10 to 20 % are sufficient to get a pH-independent matrix
• The flexibility of EUDRAGIT^® FS 30 D makes this polymer particularly suitable for the mixing with EUDRAGIT^® L 30 D-55
• Amounts below 50 % do only influence the flexibility of the EUDRAGIT^® L 30 D-55 coating, not the release profile. With amounts > 75 % specific sites in the GI tract can be targeted.

CAS number: 26936 – 24 – 3
Chemical/IUPAC name: Poly(methyl acrylate-co-methyl methacrylate-co-methacrylic acid) 7:3:1
INCI name: Acrylates Copolymer 
 

Monographs

        Ph. Eur.: n/a
        USP/NF: n/a
        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: # 13941
Weight average molar mass: approx. 280,000 g/mol
Acid Value: 70 mg KOH/ g polymer
Minimum Film Forming Temperature (MFT): ~14°C
Glass Transition Temperature (Tg): ~48°C

An according EIP format is available on request.