Guide on Quality Attributes for Chewable Tablets

FDA has posted a guidance on “Quality Attribute Considerations for Chewable Tablets” that provides the agency’s current thinking on the critical quality attributes that should be assessed during the development of such products. It also provides recommendations for sponsors/applicants regarding the submission of developmental, manufacturing, and labeling information for chewable tablets in applications. The guidance says critical quality attributes for chewable tablets should include hardness, disintegration, and dissolution, as well as all factors that may influence drug bioavailability and bioequivalence. “In addition, careful attention should be given to tablet size, thickness, and friability, as well as taste, which may impact the ability or willingness of a patient to chew the chewable tablet (i.e., a patient may swallow whole, rather than chew, a bad tasting tablet),” it says.