USFDA has released GUIDANCE for Quality Attributes of *CHEWABLE TABLETS

*CQAs of CHEWABLE TABLETS (CT)*

USFDA has released GUIDANCE for Quality Attributes of *CHEWABLE TABLETS*

According to this latest guideline, FDA has recommended sponsor/applicant should also incorporate following CQAs:

*1. PATIENT ACCEPTABILITY*

Acceptable Taste, Mouthfeel & Aftertaste With-

*2. HARDNESS / BREAKING FORCE / CRUSHING STRENGTH*

Hardness of CTshould be kept  low  (i.e.  <12 kp).

A higher hardness  value  (e.g.,  >12 kp)  may  be  considered if  justified.  An example  of  such justification could be  demonstrating  significant disintegration and/or  reduction in hardness  of  such  tablets  following  brief  i.e.  30 seconds  in-vitro exposure to simulated saliva (1 mL) before chewing to ensure patient compliance without  GI  obstruction (choking in throat / blocking bowel movement) in the case if patient swallow tablet without chewing due to high hardness

*3. CHEWING DIFFICULTY INDEX*

CDI is a value derived from the relationship between two methods used for measuring tablet strength: diametral compression (diametrical tensile strength)…