Ever had a tablet that was too big and you wished you could chew it?  Well, some immediate-release tablets are designed to be chewable and carry such designation.  The Guidance, titled “Quality Attribute Considerations for Chewable Tablets” (here), addresses the desired features of chewable tablets and describes the attributes that FDA evaluates when developing such products either in an NDA or ANDA.

Some of the characteristics that should be considered for chewable tablets include:

  • It should be easy to chew (too hard could cause problems with teeth or dentures)
  • Should be palatable (the Guidance suggests a pleasant taste or a taste-masked formulation)
  • Be of appropriate size and shape (the document references FDA Guidance on “Size, Shape and Other Physical Attributes of Generic Tablets and Capsules”, which may imply that making a tablet chewable may not permit one to skirt the requirements of size and shape as outlined in that Guidance)
  • Having appropriate disintegration characteristics to minimize aspiration and assist dissolution

Additional consideration such as: what happens if the tablet is swallowed whole, are there issues with buccal absorption (to be described in an NDA), and a host of other issues are described such as hardness disintegration and dissolution. chewing difficulty index, labeling, etc.

Lots to consider whether developing a chewable product through an NDA or ANDA.  But at least now there is a document that firms can rely upon, albeit the document in only in draft.