A new modified wetting test and an alternative disintegration test for orally disintegrating tablets

作者：Hooper Patrick; Lasher Jason; Alexander Kenneth S; Baki Gabriella^*

来源：Journal of Pharmaceutical and Biomedical Analysis, 2016, 120: 391-396.

DOI：10.1016/j.jpba.2015.12.046

• Wetting test
• Disintegration
• ODT
• Orally disintegrating tablet
• Water absorption
• Oral disintegration

Industrial manufacturing of solid oral dosage forms require quality tests, such as friability, hardness, and disintegration. The United States Pharmacopeia (USP) disintegration test uses 900 mL of water. However, recent studies of orally disintegrating tablets (ODTs) have shown that this volume does not accurately portray the oral environment. In our study, various tests were conducted with a more moderate amount of water that accurately resembles the oral environment. A simulated wetting test was performed to calculate the water absorption ratio. Results showed that wetting was comparable to disintegration. Although the wetting test worked for most types of ODTs, it had limitations that produced inaccurate results. This led to the use of a modified shaking water bath test. This test was found to work for all types of ODT products and was not subject to the limitations of the wetting test. The shake test could provide disintegration times rather than water permeation times; however, it could not be used to calculate the water absorption ratio. A strong correlation was observed between the standardized shake test and the USP disintegration times for the tablets. This shake test could be used during the development stages and quality tests for ODTs with relative ease.

• 出版日期2016-2-20