Effect of Neutralization of Poly(Methacrylic Acid-co-ethyl Acrylate) on Drug Release From Enteric-coated Pellets Upon Accelerated Storage

ABSTRACT

The effect of neutralization of poly(methacrylic acid-co-ethyl acrylate) or poly(MA-EA) 1:1 (Eudragit® L 30 D-55) on drug release from enteric-coated pellets was studied upon accelerated storage. The dissolution rate of un-neutralized poly(MA-EA)-coated pellets decreased while the neutralized polymer-coated pellets maintained a constant drug release rate. Dynamic mechanical analysis showed that both un-neutralized and neutralized poly(MA-EA) films became rigid on aging. However, the un-neutralized films were affected more than those neutralized. Neutralization of poly(MA-EA) significantly changed the mechanical properties of coating films and improved the stability of poly(MA-EA) enteric-coated pellets upon accelerated storage at the studied conditions.

KEYWORDS:

• Poly(methacrylic acid-co-ethyl acrylate)
• Eudragit® L 30 D-55
• Neutralization
• Enteric coating
• Dissolution
• Mechanical property
• Stability