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) and flexural bending (flexure tensile strength test), to ensure patient compliance without damage to teeth or dentures

CDI should be also evaluated before & after in-vitro exposure to 1 mL of simulated saliva for 30 seconds

*4. DISINTEGRATION & DISSOLUTION*

CT should  typically  meet the  same  disintegration  and dissolution specifications  as _IR  tablets_. In vitro DT & Dissolution testing  should be  conducted on  _intact_ chewable  tablets since  _it is  possible  that some  patients  might swallow  the  tablets  without chewing_.

*5. Others*

If functional coated particles are present in chewable tablet then applicant has to ensure its functionality even after chewing tablets.

https://www.fda.gov/downloads/Drugs/Guidances/UCM507098.pdf

////////////USFDA, GUIDANCE, Quality Attributes, CHEWABLE TABLETS

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