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. Examples of this application have been described in
a recently published article which can be freely downloaded at: http://www.malvern.com/common/downloads/MRK1142-01.pdf
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. http://www.malvern.com/common/downloads/MRK1142-01.pdf
Posted November 19th, 2008