Abstract:
OBJECTIVE To prepare enteric films and investigate the effect of coating materials and additives on films’ properties. METHODS Free films of Eudragit NE 30D/L 30D-55 and Eudragit FS 30D/L 30D-55 were prepared by plane casting method. The films component and additives, such as plasticizer (triethyl citrate, TEC), antisticking agent (glyceryl monostearate, GMS) and emulsifier (Tween-80) were investigated for films permeability and mechanical properties. RESULTS The addition of Eudragit NE 30D or Eudragit FS 30D to Eudragit L 30D-55 could enhance the ductility, flexibility and impact resistance ability, but reduce the intensity and increase the moisture permeability of the combination films. The combination films prepared by Eudragit NE 30D showed high moisture permeability, indicating the films were inappropriate for humidity sensitive drugs. The addictive of TEC and Tween-80 could improve the flexibility and elasticity, and reduce the intensity of the combination films. TEC could increase the moisture permeability, and the ratio of GMS had little effect on the casted films permeability and mechanical properties. CONCLUSION Enteric combination films can be prepared by simply adjusting the kinds and amounts of film component and additives to meet the manufacture requirements.