Characterization of orally disintegrating films: A feasibility study using an electronic taste sensor and a flow-through cell


In the early development stage of orally disintegrating films (ODFs), suitable evaluation methods must be used. The aim of this study was to demonstrate the feasibility of using an electronic taste sensor and a flow-through cell for ODFs. A pullulan film loaded with donepezil hydrochloride (DH) was designed, as a model ODF. The film was prepared using the solution/solvent casting method. First, the dissolution profiles were compared by using a paddle method (PD) and a flow-through cell method (FT) under three flow rates. Dissolution tests using both methods were carried out successfully. Secondly, the bitterness of ODFs was determined by a new system combining a flow-through cell apparatus and an electronic taste sensor apparatus. The results indicated that the FT method can collect eluate for the bitterness test. They also suggested that these methods are useful for evaluating ODFs. The sensor output was strongly correlated with the dissolution behavior at the initial stage of administration. This new system with a flow-through cell and an electronic taste sensor could be used to evaluate the palatability of ODFs and to improve film formulation.