Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances
This guidance provides insight to manufacturers with recommendations for submission of new drug applications (NDAs), investigational new drug applications (INDs), or abbreviated new drug applications (ANDAs), for orally administered immediate-release (IR) drug products that contain highly soluble drug substances.
This guidance helps in deciding the dissolution testing and specification criteria for Immediate-Release Solid Oral Dosage Forms containing Biopharmaceutics Classification System Class 1 and 3 Drugs as it is based on the solubility of the drug substance in the drug product. Thus, it is not necessary to refer biopharmaceutics classification system (BCS) class 1 and class 3 because permeability requirements are not within the scope of this guidance.
The recommendations in this guidance provide insight to industries on Dissolution Testing of Immediate Release Solid Oral Dosage Forms (August 1997) for high solubility drug substances in IR drug products .
For drug substances that are not been covered in this guidance, need to follow the recommendations provided in the August 1997 guidance.
For details please refer to the link provided below: