USFDA has released GUIDANCE for Quality Attributes of *CHEWABLE TABLETS

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

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INDUSTRIAL PROCESS EVALUATION AND SELECTION FOR TABLETS

INDUSTRIAL PROCESS EVALUATION AND SELECTION FOR TABLETS

Determine the unit operations needed to manufacture the tablets.
1. Mixing or Blending:
Materials that have similar physical properties will be easier to form a uniform mix or blend and will not segregate as readily as materials with large differences.
Parameters to consider
:read all at
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