FDA issues draft guidance for chewable tablets: 4 things to know

The US Food and Drug Administration recently introduced new draft guidance on Thursday, encouraging drug companies to consider quality attributes when developing chewable tablets.

Here are four things to know about the draft guidance:

1. The guidance responds to many approved chewable tablets that show poor critical quality attributes including hardness, disintegration and dissolution.
   
   
2. According to the FDA, a chewable tablet should have the following four characteristics: easy to chew, palatable, appropriate size and shape and able to disintegrate readily to maximize aspiration and facilitation of dissolution.
   
   
3. The guidance is mostly aimed at new drug applications, abbreviated new drug applications, and some chemistry, manufacturing and controls supplements. However, the FDA says some recommendations also apply to investigational new drug applications.
   
   
4. The FDA urges companies that produce already-approved tablets to reevaluate the products' critical quality attributes. The agency warns that it will take appropriate actions to alleviate risks to the public health for any tablets that do not meet quality expectations.
   
   

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