Design of a new disintegration test system for the evaluation of orally disintegrating films.

In the design of the orally disintegrating films (ODFs), it is important to determine the disintegration time (DT) precisely and properly. These films' DTs are usually assessed by a disintegration test defined in the pharmacopoeias, but under the conditions of such tests, a much larger volume of water is used and a stronger up-down movement is applied compared to the conditions of the human oral cavity. Here we developed and tested our new disintegration test system for ODFs. We chose a disintegration test device (the Tricorptester®, Okada Seiko, Tokyo) for orally disintegrating tablets. This device enabled the mechanical dropping of the test medium. We designed an exclusive fixture for ODFs, made an opening in the center of the fixture, and optimized the size of the opening (i.e., the cell). We also investigated that test conditions including the types of test media, the dropping height, flow rate, dropping methods, and medium holding methods. With a passage sensor attached to the Tricorptester, the device was able to automatically detect the DTs of ODFs. We thus successfully developed a new disintegration test system and optimized the operating conditions. Using this system, model ODFs and the commercial ODFs can be properly evaluated.