Lactic acid-induced modifications in films of Eudragit RL and RS aqueous dispersions.

Eudragit RL (ERL) and RS (ERS) are polymethacrylate co-polymers, used in film coating of sustained release dosage forms, possessing some hydrophilic properties due to the presence of quaternary ammonium groups (QAG), where ERL contains more of such groups, hence more permeable, than ERS. However, because these groups ionize in solution, they undergo electrostatic interaction with negatively charged species. This phenomenon was utilized in this study to introduce modification in the film properties of ERL and ERS by interaction with lactic acid (LA). Thermal and mechanical analyses were carried out on polymeric free films. DSC showed a shift in Tg of the film while 1H NMR spectroscopy revealed a significant deshielding in the peak of QAGs protons after interaction with LA. Stress-strain test showed an increase in three mechanical parameters of the new film (containing LA): tensile strength to modulus ratio, relative surface energy and toughness index, indicating an enhancement in the mechanical stress resistance. Tablets coated with LA-containing films showed an increase in the release rate and extent and good stability upon aging, compared to those coated with the original film.