ABSTRACT

Since the 1960s, pharmaceutical companies have been charged

with monitoring the characteristics of their oral dosage forms

dissolving in controlled media. Early dissolution testing focused on

the quality control of the dosage form manufacturing. Dissolution

testing provided unique capabilities in monitoring integrated

production parameters that affect the dissolution rate: tablet

hardness, excipient control, particle size, etc. The technique became

required for the routine testing of oral dosage forms worldwide.

The early history of dissolution testing is well documented in the

literature.1−3