An evaluation of the gliding performance of solid oral dosage form film coatings using an artificial mucous layer.

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.