A comparative study on different enteric-coated hard capsules was performed. The influence of different formulation factors like choice of enteric polymer, triethyl citrate (TEC) concentration (plasticizer), talc concentrations (anti-tacking agent), and different coating process parameters on the sealing performance of the capsule and the disintegration time were investigated. Furthermore, the influence of different disintegration test methods (with disc vs. without disc and 50 mM U.S. Pharmacopoeia (USP) buffer pH 6.8 vs. biopredictive 15 mM phosphate buffer pH 6.5) was evaluated. All formulations showed sufficient but not equivalent acid resistance when tested. Polymer type was the main factor influencing the capsule sealing and disintegration time. In addition, TEC and talc could affect the performance of the formulation. Regarding the choice of the disintegration test method, the presence of a disc had for the most part only limited influence on the results. The choice of disintegration buffer was found to be important in identifying differences between the formulations.

中文翻译：

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肠溶HPMC胶囊的体外评估-配方因素对产品性能的影响。

对不同的肠溶硬胶囊进行了比较研究。研究了不同配方因素，如肠溶性聚合物的选择，柠檬酸三乙酯（TEC）的浓度（增塑剂），滑石粉的浓度（防粘剂）以及不同的包衣工艺参数对胶囊的密封性能和崩解时间的影响。此外，评估了不同崩解测试方法的影响（使用圆盘vs.不使用圆盘，以及50 mM美国药典（USP）缓冲液pH 6.8和生物预测15 mM磷酸盐缓冲液pH 6.5）的影响。测试时，所有配方均显示出足够的耐酸性，但不相等。聚合物类型是影响胶囊密封和崩解时间的主要因素。另外，TEC和滑石粉可能影响制剂的性能。关于崩解测试方法的选择，圆盘的存在对结果的影响很大。发现崩解缓冲液的选择对于鉴定制剂之间的差异很重要。