Dissolution Testing measures the release of a drug product’s active substance in a controlled laboratory environment that mimics in-vivo conditions. This test is a key parameter in evaluating the drug product during development and manufacturing. It is the only standardized way to generate scientific data that enables predicting bioavailability (a surrogate parameter of therapeutic efficacy), indicating robustness of the dosage form (drug product safety) and implicating variations in manufacturing (which may have a critical influence on performance).
When a dosage form is manufactured, a number of parameters that need to be checked:
• The active ingredient is released as predicted.
• Drug product bioequivalence has been assessed adequately.
• Bioavailability (where applicable) has been evaluated and assured.
• The manufactured batch has the same specifications as previous batches and falls within acceptable boundaries.
• The product can be stored for the specified shelf life without deterioration.
• The manufacturing process is still controlled.
In an attempt to mimic in vivo conditions, the choice of apparatus and method parameters such as medium composition, pH and sampling frequency vary depending on the dosage form and overall purpose of the test. USP <711> describes apparatus types and procedural recommendations for testing immediate-, extended- and delayed-release dosage forms. Nomenclature for compendial apparatus for dissolution testing includes USP 1 baskets, USP 2 paddles, USP 3 reciprocating cylinders, USP 4 flow through cell, USP 5 paddle over disk, USP 6 cylinders and USP 7 reciprocating holders.
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