FDA Finalizes Dissolution Testing Guidance for Immediate-Release Solid Oral Dosage Forms

The FDA issued final guidance Wednesday on dissolution testing for immediate-release solid oral dosage form drugs containing high solubility substances.

The guidance clarifies the agency’s August 2015 draft with an expanded section on eligible products. The draft said the guidance applied to oral, immediate-release dosage forms and not chewable or orally disintegrating tablets, but the final guidance says it may apply to chewable pills if dissolution studies are conducted on the intact tablets.

The final guidance also clarifies that it does not apply to sublingual dosage forms, noting “the scientific principles upon which this guidance is premised do not apply to the sublingual route of delivery, since sublingual dosage forms are intended for absorption in the oral cavity.”