Dissolution Method Development for Poorly Soluble Compounds

Developing dissolution methods for poorly soluble co m pounds has been a consistent

Challenge for the pharmaceutical scientist. Be cause of inherently slow dissolution, poorly soluble co m pounds are good candidates for developing in vitro-in vivo correlations (IVIVCs) if intestinal permeability is high and drug dissolution is the controlling mechanism for the release of drug from the dosage form.

Dissolution problems with poorly soluble compounds generally fall into two categories. First, extent of release is too low, i.e. one cannot get 100% of the dosage form dissolve d. Second, rate of release is too slow, i.e. one cannot get dissolution fast

enough for a convenient test .This article presents the equations that govern extent and rate, and strategies to affect each variable within the equations will be discussed. It is assumed that the dissolution test will be utilized for quality control and that what is desired is a test that will dissolve a large fraction of the dose in a reasonable amount of time.

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