H-AN-007 Comparison of CD-14 vs Vision Elite 8 with Autosampler 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, 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 (FDA), “the objective of in vitro dissolution testing is to evaluate the variables that affect the rate and extent of release of a drug substance from the finished dosage form, which affects 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, dissolution testing is one of the most important product performance tests.

Teledyne Hanson manufactures and sells the highest quality dissolution testers to meet all the regulatory requirements from the USP, U.S. FDA, ASTM, EP, JP, CE, CSA, and RoHS, as well as having 21 CFR part 11 compliance. Dissolution products sold by Teledyne Hanson include the Vision Classic 6, Vision G2 Elite 8, and the Comparative Dissolution (CD14) system. In this paper, two dissolution tester configurations are compared: the CD14 with two CD AutoPlus autosamplers, and two Vision G2 Elite 8 system with one AutoPlus autosampler.

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Resources
1. United States Pharmacopeia. Dissolution Testing and Drug Release Tests [Internet]. www.usp.org. Available from: https://www.usp.org/small-molecules/dissolution
2. U.S. Food and Drug Administration. Compilation of FDA Guidance and Resources for in vitro Dissolution Testing of Immediate Release Solid Oral Dosage Forms. https://www.fda.gov/animal-veterinary/new-animal-drug-applications/compilation-fda-guidance-and-resources-in-vitro-dissolution-testing-immediate-release-solid-oral-dosage. Accessed 06/07/2022.