Predicting the Release of APIs by Near-Infrared Spectroscopy

Sustained-release formulations that gradually release active pharmaceutical ingredients (APIs) have numerous therapeutic benefits, but they also involve time-consuming quality control. Near-infrared spectroscopy (NIRS) offers a fast and simple alternative to tedious dissolution testing: by using NIRS and appropriate calibration models, the release of APIs from sustained-release tablets can be predicted accurately within a matter of minutes. More details are available from a recently published paper.

Drug release is still frequently assessed by dissolution tests, a procedure, in which the tablet is placed in a solvent with similar properties to gastric acid. The free active ingredient is then determined at regular intervals, which can take up to 24 hours, depending on the desired release period.

NIRS offers a viable alternative to dissolution testing. By using NIRS together with an appropriate calibration model, it is possible to predict the dissolution behaviour of tablets accurately in a matter of minutes. Moreover, NIRS, unlike dissolution testing, is non-destructive, which allows larger sample quantities to be analysed.