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

• Modified wetting test for orally disintegrating tablets was devised to more accurately depict oral environment.
• Standardization of wetting test based on results of different base material, and volumes of test solution.
• Alternative disintegration test devised to more accurately portray oral cavity compared to standard disintegration tests.
• Resulting data shows possibility to refine this alternative disintegration test, to reliably and more accurately portray oral disintegration times for ODT products.

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.

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