Dissolution Testing and Acceptance Criteria: FDA Finalizes Guidance
Posted 08 August 2018 | By
The US Food and Drug Administration (FDA) on Wednesday released final guidance for sponsors on when a standard release test and criteria may be used in lieu of extensive method development and acceptance criteria-setting exercises.
In terms of changes between the draft and final versions, FDA notes that the title of this guidance has been revised “to better reflect its focus on the solubility of the drug substance in the drug product. Therefore, a direct reference to biopharmaceutics classification system class 1 and class 3 is not necessary because permeability requirements are not within the focus of this guidance.”
The 8-page guidance, FDA said, establishes standard dissolution methodology and acceptance criteria that are appropriate for highly soluble drug substances that are formulated in immediate release dosage form.
“The availability of these standards will facilitate the rapid development of dissolution methodology and related acceptance criteria with no requirement to show discriminatory ability of the dissolution method for these products during drug product development. In addition, these standards will facilitate FDA's evaluation of the data submitted in the application,” FDA added.
In general, knowledge about the solubility, permeability, dissolution and pharmacokinetics of a drug product is considered when defining dissolution acceptance criteria for the drug approval process, FDA explained.
For drug substances that do not meet the conditions in this guidance, FDA said that sponsors/applicants should follow the recommendations provided in the August 1997 guidance, entitled "Dissolution Testing of Immediate Release Solid Oral Dosage Forms."
Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances Guidance for Industry