Use of the Teledyne LABS CD14 for Dissolution Testing of an
Extended Release Product—Diltiazem HCl CD Capsules, 180 mg
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, using the world wide accepted concept of obtaining the similarity factor (f2), which
can be generated to prove the similarities between two products such as reference listed drug (RDL) and proposed generics. The same concept is also used for comparing two products after any changes are made per scale-up and post-approval change (SUPAC) guidance. The similarity factor is required for comparing dissolution profiles and to evaluate relative in vitro performance resulting from changes in raw materials, formulation, and/or manufacturing for both development and commercial products.
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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