www.fdanews.com/articles/177209-fda-clarifies-quality-attributes-for-chewable-tablets
FDA Clarifies Quality Attributes for Chewable Tablets
June 22, 2016
The FDA is pushing for more uniform qualities for chewable tablets after finding significant variation among manufacturers.
In draft guidance published last week, the agency is recommending that drugmakers submitting NDAs and ANDAs evaluate the hardness, disintegration and dissolution of their tablets. Other considerations include tablet size, thickness, friability and palatability.
In a review of approved chewable drugs, the agency noted that many drugmakers had neglected to fully consider all of these attributes, leading to adverse effects such as tooth damage.