Earlier today (03-October-2022) USFDA's Center for Drug Evaluation and Research released an important CMC topic and final guidance " Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules".
The physicochemical properties of tablets and capsules have a direct impact on the transit of the drug through the pharynx and esophagus and it has been shown that larger tablets and capsules take longer to transit through the esophagus.
As a result, the product can disintegrate in the esophagus, causing localized esophagitis and potentially serious sequelae, such as ulceration, stricture, and perforation.
The USFDA is recommending that generic drug manufacturers consider physical attributes when they develop quality target product profiles (QTPPs) for their generic product candidates.
In this guidance, recommendations are provided for abbreviated new drug applications (ANDAs) and supplements for additional strengths submitted to the Office of Generic Drugs (OGD). This guidance does not apply to approved ANDAs (generic drugs) already on the market.
This guidance is not intended to apply to other oral dosage forms (e.g., chewable tablets, oral tablets for suspension/solution, orally disintegrating tablets, sublingual tablets, troches, gums).
The recommendations in this guidance are based on published literature regarding patient experiences swallowing tablets and capsules and Agency experience with NDAs and ANDAs submitted for oral tablets and capsules.
Click this LINK to know more about the recommendations in this guidance.
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