Malvern's Synirgi near infrared chemical imaging (NIR-CI) system is being used for the advanced troubleshooting of dissolution failures in tablets and granules.
Synirgi provides accurate measurement of the spatial distribution of pharmaceutical ingredients.
It enables chemical composition and structural data to be obtained non-destructively, so that subsequent dissolution testing can be performed on the same sample.
This eliminates the need for destructive testing of different tablets from the same batch and removes any reliance on the statistical correlation of results.
Examples of this application have been described in a recently published article that can be freely downloaded from Malvern's website.
The results described in the article indicate that using the Synirgi can help in understanding why some batches of tablets, prepared using the same ingredients and following the same process, can have different dissolution profiles.
Such information on the causes of dissolution failure is often impossible to obtain using conventional techniques such as HPLC.
NIR-CI combines spectroscopy with digital imaging and produces images and statistics that describe the spatial distribution of sample components in the tablet.
Collecting data over the spectral range 1200-2450nm, the Synirgi provides the best possible chemical specificity in the NIR range.
It is suitable for assessing the micro characteristics of samples consisting of spatially complex arrangements of chemical species, such as pharmaceutical solid dosage forms.
