Dissolution Testing under Biowaiver Test Conditions
for Metronidazole Tablets, USP 250 mg Using the CD14
Comparative Dissolution Tester
Application Note Request
Summary
Dissolution is a well known process in which a solid substance gets dissolved into solute and forms a solution. As described by the United States Pharmacopeia (USP), “Dissolution testing measures the extent and rate of solution formation from a dosage form, such as a tablet, a capsule, ointment, etc. The dissolution of a drug is important for its bioavailability and therapeutic effectiveness. Dissolution and drug release are terms used interchangeably.”1
According to the United States Food and Drug Administration, “the objective of in vitro dissolution testing is to evaluate the variables that effect the rate and extent of release of a drug substance from the finished dosage form and, in turn, the in vivo performance of the drug product. When this objective is met, a comparison of product in vitro dissolution profiles or adherence to the product release specification ensures that the product or batch being evaluated will have consistent quality and performance.”2 Hence, the dissolution test is one of the most
important product performance tests. In vitro bioequivalence and similarities between two products are evaluated by model-independent approaches using the similarity (f2) and the difference factor (f1). The same concept is also used for comparing two products when any allowable changes are made during the production or during any new product development and when formulation optimization steps are performed. This approach is useful for immediate release and for modified released products.3 It is widely used in the pharmaceutical industry worldwide for oral solid drug development.
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References
1. USP. Dissolution Testing and Drug Release Tests [Internet]. www.usp.org. Available from: https://www.usp.org/small-molecules/dissolution
2. FDA. Compilation of FDA Guidance and Resources for in vitro Dissolution Testing of Immediate Release Solid Oral Dosage
Forms. FDA [Internet]. Available from: https://www.fda.gov/animal-veterinary/new-animal-drug-applications/compilation-fda-guidance-and-resources-in-vitro-dissolution-testing-immediate-release-solid-oral-dosage
3. FDA. Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing
High Solubility Drug Substances Guidance for Industry; August 2018