Pennings F H, Kwee B L S, Vromans H
Department of Pharmaceutics, N.V. Organon, AKZO-NOBEL, P.O. Box 20, 5340 BH Oss, The Netherlands.
Drug Dev Ind Pharm. 2006 Jan;32(1):33-7. doi: 10.1080/03639040500387955.
Gelatin exhibits cross-linking upon storage at stress conditions. Capsules stored at these conditions fail to show appropriate in vitro dissolution. The aim of this study is to show the effect of surfactants in the medium on the disintegration of the gelatin capsule. This is demonstrated in the presence and absence of the enzymes pancreatin and pepsin, the function of which is to improve the dissolution. Sodium lauryl sulfate (SLS) and Tween 80 are tested as surfactants. When SLS is used in the medium, dissolution is significantly hampered due to the formation of a less soluble precipitate of gelatin. Compared to SLS, Tween 80 shows far better disintegration and solubility results in dissolution media with neutral or low pH. Therefore, it is concluded in this study that Tween 80 is preferred when a surfactant is necessary to comply with sink condition requirements.
明胶在应激条件下储存时会发生交联。在这些条件下储存的胶囊未能表现出适当的体外溶出度。本研究的目的是展示介质中的表面活性剂对明胶胶囊崩解的影响。这在有和没有胰酶和胃蛋白酶的情况下得到了证明，它们的作用是改善溶出度。测试了十二烷基硫酸钠（SLS）和吐温80作为表面活性剂。当在介质中使用SLS时，由于形成了溶解度较低的明胶沉淀，溶出度受到显著阻碍。与SLS相比，吐温80在中性或低pH值的溶出介质中显示出更好的崩解和溶解结果。因此，本研究得出结论，当需要表面活性剂以符合漏槽条件要求时，吐温80是首选。
