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 and reliable measurement of the spatial distribution of pharmaceutical ingredients. Importantly, 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.
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 1200-2450 nm, the SyNIRgi provides the best possible chemical specificity in the NIR range. It is ideal for assessing the micro characteristics of samples consisting of spatially complex arrangements of chemical species, such as pharmaceutical solid dosage forms.
The pharmaceutical industry is placing increasing emphasis on improving manufacturing efficiency, combating counterfeiting, understanding products and processes, and developing ever more complex drug delivery systems. SyNIRgi is an increasingly valuable tool which non-destructively provides new, valuable, and detailed information about finished solid dosage forms and product intermediates.
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