In a recently published study conducted in Pakistan, Teledyne Hanson’s dissolution testers were used to assess differences in release of the active pharmaceutical ingredient (API) co-amoxiclav from finished solid dosage formulations, comparing the innovator to generic tablets. API release was determined with dissolution testing and HPLC analysis. The dissolution method used 900 mL of distilled water at 37 °C as the medium, with paddles (USP Apparatus 2) rotating at 75 rpm. The Teledyne Hanson tester (Vision G2 Elite 8) included an automatic tablet drop system. It was connected to an autosampler employing precision syringes to withdraw and collect aliquots from 6 dissolution vessels at 30-minute intervals with instant transfer to the HPLC system. The not-less-than (NLT) tolerance limit for amoxicillin and clavulanic acid is 85% (Q) of the labeled amount to be dissolved in 30 minutes. The authors concluded: “The tested generic brands of this antibiotic were found to be substandard for amoxicillin release. Differences in dissolution performance of generic products may reduce the therapeutic effect of the drug.” The full report can be found in the November 2020 issue of Dissolution Technologies magazine.
About the Vision G2 Elite 8 Tester
The Vision G2 Elite 8 tester is known for its extensive programmability and versatile performance in applications involving automated dissolution testing in R&D, QC, and stability testing labs. The Elite 8 tester meets and exceeds worldwide standards including compliance with USP, US FDA, ASTM, EP, JP, CE, CSA, RoHS, and 21 CFR Part 11.
For further information see Teledyne Hanson’s complete line of manual and automated dissolution testing systems.
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