18 November 2008; Malvern, UK: 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.
About Malvern Instruments
Malvern Instruments provides a range of complementary materials characterization tools that deliver inter-related measurements reflecting the complexities of particulates and disperse systems, nanomaterials and macromolecules. Analytical instruments from Malvern are used in the characterization of a wide variety of materials, from industrial bulk powders to the latest nanomaterials and delicate macromolecules. A broad portfolio of innovative technologies is combined with intelligent, user-friendly software. These systems deliver industrially relevant data enabling our customers to make the connection between micro (such as particle size) and macro (bulk) material properties (rheology) and chemical composition (chemical imaging).
Particle size distribution, particle shape information, zeta potential, molecular weight, chemical composition, and bulk materials properties can all be determined with instruments from the Malvern range. The company's laboratory, at-line, on-line and in-line solutions are proven in sectors as diverse as cement production and pharmaceutical drug discovery.
Headquartered in Malvern, UK, Malvern Instruments has subsidiary organizations in all major European markets, North America, China, Korea and Japan, a joint venture in India, a global distributor network and applications laboratories around the world. www.malvern.com
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