Once the dosage form reaches the absorption site, it must disintegrate, deaggregate and release its therapeutic agent. The lack of ability of a drug to go into solution is sometimes a more important limitation to its overall rate of absorption than its ability to permeate the intestinal mucosa. For many drugs that cross the intestinal…
When applying the BCS based biowaiver approach, comparative in vitro dissolution tests should be conducted using one batch representative of the proposed commercial manufacturing process for the test product relative to the reference product. The test product should originate from a batch of at least 1/10 of production scale or 100,000 units, whichever…
One major criterion for selecting the QC dissolution method should be its discriminatory power to show changes in the critical attributes of the release mechanism of the chosen formulation. The discriminatory power is the ability of a test procedure to discriminate between batches manufactured with different critical process parameters and /or critical material attributes…
Non-sink conditions refer to situations where the concentration of the drug substance in the dissolution medium is not significantly lower than its solubility. While sink conditions are commonly preferred in dissolution testing to ensure rapid and complete drug dissolution, there are certain instances where non-sink conditions can be useful. Here are a few examples:…
Sink conditions refer to a state in which the dissolution medium has sufficient volume to ensure the drug dissolves rapidly without reaching saturation throughout the duration of the test. Sink conditions = V/Vsat ≥ 3 Where, Volume of Dissolution Medium The volume of the dissolution medium should be at least 3-10 times the saturation…
