White Paper
Advanced Troubleshooting Of Dissolution Failure
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•White Paper: Advanced Troubleshooting Of Dissolution Failure
By Janie Dubois and E. Neil Lewis, Malvern Instruments
As seen in The Pharmaceutical Solutions Update, 2008 Fall Edition
Why do some batches of tablets prepared using the same ingredients and following the same process show different dissolution profiles? This question remained largely unanswered until about five years ago, because the chemical composition measured with traditional laboratory equipment, such as HPLC (high-performance liquid chromatography), often could not explain the dissolution failure. However, with the emergence of near infrared (NIR) chemical imaging systems in troubleshooting laboratories, the situation has changed, because this new technology provides access to the structure, or the arrangement of chemical entities, within solid dosage form products.
It was quickly realized that simple descriptors, such as components distribution uniformity and aggregate size, could be correlated with dissolution data and, more importantly, often help trace back the cause of the performance differences to particular manufacturing variables. This article describes the technique of NIR chemical imaging with an emphasis on how this laboratory instrument is used in advanced troubleshooting of dissolution failures in tablets and granules.
Click Here To Download:•White Paper: Advanced Troubleshooting Of Dissolution Failure
