Studies on Enteric Coating Bases. I Selection of Enteric Coating Bases by Invitro Test

9 장용피기제에 관한 연구(제1보) Invitro Test에 의한 기제의 선택에 대하여

The importance of enteric coating technique among the pharmaceutical firms has recently risen very significantly. This study of enteric coating bases was made in order to determine the most suitable bases and dusting powders. Materials and equipment used in this experiment are shown in table 1 and kinds of enteric coating bases and their formulas are shown in table 2. The evaluation of the suitability for enteric coating bases and dusting powder was made by disintergration test after measuring the thickness of the enteric coated layer as shown in the tables 4 and 5. Based on the results of this study, the base D(shellac 20 Gm, anhydrous lanoline 5 Gm, 96% alcohol 75 ml) and the base E (shellac 10 Gm, cetyl alcohol 10 Gm. acetone 80 ml) are selected among the 8 kinds of bases studied in a preliminary test and it was found that Mg-stearate and CA-stearate were in most suitable dusting powders among the 6 kinds studied for the bases D and E. Further study on base D and E was carried out by varying the proportions of the materials which were the original constituents of bases D and E. According to the result of this further study shown in table 6, the shellac 15 Gm cetyl alcohol 5 Gm Acetone 80 ml of base E is recommended as the most suitable dusting powder.