FDA issues final guidance entitled Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances

Today FDA published a guidance for industry entitled Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances.   This guidance has been developed to provide manufacturers with recommendations for submission of new drug applications (NDAs), investigational new drug applications (INDs), or abbreviated new drug applications (ANDAs), as appropriate, for orally administered immediate-release (IR) drug products that contain highly soluble drug substances. 

NDAs and ANDAs submitted to FDA contain bioavailability (BA) or bioequivalence (BE) data and in vitro dissolution data that, together with chemistry, manufacturing, and controls (CMC) data, characterize the quality and performance of the drug product.  This guidance establishes standard dissolution methodology and acceptance criteria that are appropriate for highly soluble drug substances formulated as an IR dosage form that meet the conditions described in section III of the guidance.  The availability of these standards will facilitate the rapid development of dissolution methodology and related acceptance criteria.  In addition, these standards will facilitate FDA’s evaluation of the data submitted in the application.

This guidance finalizes the guidance for industry issued in August 2015 entitled “Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs”.  This guidance also clarifies the recommendations in the guidance for industry on Dissolution Testing of Immediate Release Solid Oral Dosage Forms for certain high solubility drug substances in IR drug products.