FDA Publishes Guidance on Chewable Tablets

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The agency provides quality, development, manufacturing, and labeling recommendations.

On June 16, 2016, FDA published guidance on the Center for Drug Evaluation and Research’s (CDER) thinking in regards to the assessment of critical quality attributes in the development of chewable tablets. The guidance also addresses the submission of developmental, manufacturing, and labeling information in new drug applications (NDAs) and abbreviated NDAs (ANDA) for CDER approval. The guidance also applies to certain chemistry, manufacturing, and controls (CMC) supplements to NDAs and ANDAs.

Critical quality attributes that should be established during early development include hardness, dissolution, and disintegration of the chewable tablet. FDA also recommends the following when developing chewable tablets:

  • Potential product design and development considerations: disintegrant(s) to facilitate release of the active ingredient, and sweeteners and flavoring agents for taste-masking. Interaction of excipients with each other and/or the drug substance(s) and their likely impact on the manufacturing process.

  • Clinical trial information: The following questions should be asked and answered. Were the chewable tablets swallowed intact (i.e., without breaking) or after being thoroughly chewed? If swallowed intact, does the shape and size of chewable tablet pose a choking or bowel obstruction risk? If water was used to aid swallowing, what was the volume? What was the subject’s sensory experience (e.g., taste, mouth feel, and aftertaste)?

The guidance provides labeling information, a chewing difficulty index, and a simulated salivary fluid composition appendix.

Source: FDA