Quality Attribute Considerations for Chewable Tablets
This guidance suggests manufacturers of chewable tablets for human use with CDER’s current thinking on the critical quality attributes that should be assessed during the development of these drug products. This guidance also provides recommendations for sponsors/applicants regarding the submission of developmental, manufacturing, and labelling information for chewable tablets in applications.
The recommendations in this guidance applies to new drug applications (NDAs), abbreviated new drug applications (ANDAs), and certain chemistry, manufacturing, and controls (CMC) supplements to these applications. Some of the recommendations about the submission of developmental information may also apply to investigational new drug applications (INDs). The recommendations about assessing critical quality attributes apply to all immediate release (IR) chewable tablets for human use, including non-application products.
The United States Pharmacopeia (USP) recognizes and differentiates between two types of chewable tablets: (1) those that may be chewed for ease of administration, and (2) those that must be chewed or crushed before swallowing to avoid choking and/or to ensure the release of the active ingredient. The concepts in this guidance are applicable to both types of chewable tablets.
This guidance describes the critical quality attributes that should be considered when developing chewable tablets and recommends selection of acceptance criteria that are appropriate and meaningful indicators of product performance throughout the shelf life of the product.
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