Drug Dissolution: Requirements and Profile Comparison

Dissolution profile data is accepted based on Q values or the percentage of drug dissolved within a given time.

The dissolution testing is done in three stages.

A drug passes the stage 1 test if all six dosage units are ≥ Q + 5%; otherwise, it goes to the second stage.

Here, the average of twelve units must be ≥ Q, and no unit should be < Q - 15%; if not, it proceeds to the final stage.

The final stage requires an average of twenty-four units to be ≥ Q, with no more than 2 units < Q - 15% and none < Q - 25%.

Additionally, dissolution profile comparisons help develop bioequivalent drug products and demonstrate equivalence after formulation changes.

It involves calculating the difference factor, f₁, and the similarity factor, f₂. Two dissolution profiles are identical if f₁ is 0 and f₂ is 100.