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Dissolution testing measures the extent and rate of solution formation from a dosage form, such as 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.
Two general approaches to compare dissolution profiles were examined: model-independent approaches and model-dependent approaches. The model- independent methods included ANOVA-based procedures, ratio test procedures, and pair- wise procedures.
Rate of dissolution is a critical quality attribute of a pharmaceutical tablet. Tablet dissolution is typically studied by examining the form of the dissolution profile, which is the percentage of the tablet dissolved at various points in time.
Dissolution testing should be carried out under mild test conditions, basket method at 50/100 rpm or paddle method at 50/75 rpm, at 15-minute intervals, to generate a dissolution profile. For rapidly dissolving products, generation of an adequate profile sampling at 5- or 10-minute intervals may be necessary.
The single point dissolution test is only one withdrawn sample but in dissolution profile testing, multiple samples are withdrawn that may affect the % dissolved at 30 minutes in a possible significant or non significant. The drug filtered, after each withdraw, on filter paper or sample filter may affect its %.