TY - JOUR
T1 - Evaluation of poly(styrene-alt-maleic anhydride)-ethanol as enteric coating material
AU - Lai, Xiaolin
AU - Sun, Chengdong
AU - Tian, Hua
AU - Zhao, Wenjun
AU - Gao, Lin
N1 - Funding Information:
The authors express their sincere thanks to the Western Light Programs of the Chinese Academy of Sciences for the financial assistance and to Dr. Danhong Yang for assistance with the experiments.
PY - 2008/3/20
Y1 - 2008/3/20
N2 - This study aims at evaluating the potential of SMA-ethanol as enteric coating polymer for erythromycin tablets. SMA-ethanol was synthesized and characterized for physicochemical properties, molecular weight and thermal analysis. Free films were prepared by adding different kinds and amounts of plasticizers, the film surface topography was determined by a SEM, the tensile strength, water vapor transmission rate and moisture absorption were also tested to choose the most promising film. DBP was proved to be the most suitable plasticizer with a best using amount of 20%, such polymer films had low vapor transmission rate and low moisture absorption which were very important to an enteric coating material. The polymer was further characterized for film coating by evaluating the release of erythromycin tablets in vitro, tablets coated with SMA-ethanol can satisfy the drug release requests of USP when the film weight gains were between 4 and 6%; tablets coated with both a subcoat and the polymer showed excellent gastro-resistance, less than 0.2% drug release occurred even with weight gains as less as 2% after 2 h exposure to acid (pH 1), while over 90% drug release occurred in pH 6.8 sodium phosphate buffer within 45 min, regardless of weight gains of coating material, moreover, we confirmed that the application of a subcoat could decrease the amount of required coating polymer. In conclusion, the potential use of SMA-ethanol as enteric coating material was demonstrated.
AB - This study aims at evaluating the potential of SMA-ethanol as enteric coating polymer for erythromycin tablets. SMA-ethanol was synthesized and characterized for physicochemical properties, molecular weight and thermal analysis. Free films were prepared by adding different kinds and amounts of plasticizers, the film surface topography was determined by a SEM, the tensile strength, water vapor transmission rate and moisture absorption were also tested to choose the most promising film. DBP was proved to be the most suitable plasticizer with a best using amount of 20%, such polymer films had low vapor transmission rate and low moisture absorption which were very important to an enteric coating material. The polymer was further characterized for film coating by evaluating the release of erythromycin tablets in vitro, tablets coated with SMA-ethanol can satisfy the drug release requests of USP when the film weight gains were between 4 and 6%; tablets coated with both a subcoat and the polymer showed excellent gastro-resistance, less than 0.2% drug release occurred even with weight gains as less as 2% after 2 h exposure to acid (pH 1), while over 90% drug release occurred in pH 6.8 sodium phosphate buffer within 45 min, regardless of weight gains of coating material, moreover, we confirmed that the application of a subcoat could decrease the amount of required coating polymer. In conclusion, the potential use of SMA-ethanol as enteric coating material was demonstrated.
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U2 - 10.1016/j.ijpharm.2007.10.011
DO - 10.1016/j.ijpharm.2007.10.011
M3 - Article
C2 - 18054184
AN - SCOPUS:39449089160
SN - 0378-5173
VL - 352
SP - 66
EP - 73
JO - International Journal of Pharmaceutics
JF - International Journal of Pharmaceutics
IS - 1-2
ER -