PDF(Pubmed)
Abstract：
The coating process for solid dosage forms is widely used in the pharmaceutical industry but presents challenges for small-scale production, needed in personalized medicine and clinical or galenic settings. This study aimed to evaluate immersion coating, a cost-effective small-scale method, for enteric-coated gelatin capsules using standard equipment. Two enteric coating polymers and different polymer concentrations were tested, along with API solubility. Results were compared with commercially available enteric capsule shells. Successful preparation of enteric coating capsules via immersion necessitates a comprehensive grasp of API and enteric polymer behavior. However, utilizing commercially available enteric capsule shells does not guarantee ease or robustness, as their efficacy hinges on the attributes of the active ingredient and excipients. Notably, coating with Eudragit S100 stands out for its superior process robustness, requiring minimal or no development time, thus representing the best option for small-scale enteric capsule production.
摘要：
固体剂型的包衣工艺广泛用于制药行业，但对小规模生产提出了挑战。在个性化医疗和临床或盖伦环境中需要。本研究旨在评估浸渍涂层，一种具有成本效益的小规模方法，使用标准设备的肠溶明胶胶囊。测试了两种肠溶衣聚合物和不同的聚合物浓度，以及API溶解度。将结果与市售的肠溶胶囊壳进行比较。通过浸渍成功制备肠溶衣胶囊需要全面掌握API和肠溶聚合物的行为。然而,利用市售的肠溶胶囊壳不能保证易用性或坚固性，因为它们的功效取决于活性成分和赋形剂的属性。值得注意的是,EudragitS100涂层因其卓越的工艺鲁棒性而脱颖而出，需要最少或不需要开发时间，因此代表了小规模肠溶胶囊生产的最佳选择。
