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Abstract：
Oral drug delivery technology is mainly provided in the form of solid oral dosage forms (SODF) that have to be swallowed intact and move throughout the oro-esophageal system to release the drug content in the stomach or intestine. As there is growing evidence for an increasing prevalence of impaired swallowing functions in certain diseases, multimorbidity and advanced age, predictive in vitro methods for the oro-esophageal gliding behavior of SODF would be very useful. The gliding performance of different SODF polymer films was investigated across an artificial mucous layer using a versatile in vitro gliding system. In a first phase, the system measures the force required to move the polymer surface when placed in contact with the mucin layer and, in a second phase, the resistance behavior over a defined length. The obtained results showed that comprehensive gliding profiles could be obtained depending on the polymer film tested. The carnauba wax and PEG coatings required lower gliding peak forces and showed poor gliding resistance, which is indicative of free gliding capacity. In contrast, HPMC, PVP and gelatin coatings required higher gliding forces and exhibited greater resistance due to an adhesive interaction with the artificial mucous layer. The obtained profiles correlate with prior in vitro data during polymer gliding evaluations on mucosal membranes.
摘要：
口服药物递送技术主要以固体口服剂型(SODF)的形式提供,所述固体口服剂型必须完整地吞咽并在整个口食管系统中移动以在胃或肠道中释放药物内容物。随着越来越多的证据表明在某些疾病中吞咽功能受损的患病率增加，多发病率和高龄，预测SODF的口食管滑翔行为的体外方法将非常有用。使用通用的体外滑翔系统研究了不同SODF聚合物膜在人造粘液层中的滑翔性能。在第一阶段,当与粘蛋白层接触时，系统测量移动聚合物表面所需的力，在第二阶段，在定义的长度上的电阻行为。获得的结果表明，根据所测试的聚合物膜，可以获得全面的滑行曲线。巴西棕榈蜡和PEG涂层需要较低的滑动峰值力，并且显示出较差的抗滑动性，这表明了自由滑行的能力。相比之下,HPMC,PVP和明胶涂层需要较高的滑动力，并由于与人造粘液层的粘附相互作用而表现出更大的阻力。在粘膜上的聚合物滑动评估期间，获得的曲线与先前的体外数据相关。
