Laboratory of Pharmaceutical Engineering, Gifu Pharmaceutical University, 1-25-4 Daigaku-nishi, Gifu 501-1196, Japan.
Laboratory of Pharmaceutical Engineering, Gifu Pharmaceutical University, 1-25-4 Daigaku-nishi, Gifu 501-1196, Japan.
Int J Pharm. 2018 Dec 20;553(1-2):281-289. doi: 10.1016/j.ijpharm.2018.10.049. Epub 2018 Oct 23.
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.
在口崩片（ODF）的设计中，精确和适当确定崩解时间（DT）非常重要。这些薄膜的 DT 通常通过药典中定义的崩解试验来评估，但在这些试验条件下，与口腔中的条件相比，使用了更大体积的水，并施加了更强的上下运动。在这里，我们开发并测试了我们用于 ODF 的新型崩解试验系统。我们选择了一种用于崩解的试验设备（片剂崩解仪 Tricorptester ® ，Okada Seiko ，东京）。该设备能够实现试验介质的机械下降。我们为 ODF 设计了一个专用的固定装置，在固定装置的中心开一个口，并优化了开口的尺寸（即细胞）。我们还研究了包括试验介质类型、下降高度、流速、下降方法和介质保持方法在内的试验条件。通过在 Tricorptester 上附加一个通道传感器，该设备能够自动检测 ODF 的 DT。因此，我们成功开发了一种新的崩解试验系统并优化了操作条件。使用该系统，可以对模型 ODF 和商业 ODF 进行适当评估。
