Makein, Lisa Jane; (2007) Correlation of Near-infrared Chemical Imaging of Pharmaceutical Dosage Forms with their Dissolution Performance. Doctoral thesis (Ph.D), UCL (University College London).

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Abstract

Dissolution testing within the pharmaceutical industry provides valuable information regarding the drug release. Near-infrared microscopy (NIRM) imaging falls under the process analytical technology (PAT) heading promoting process and product understanding and can provide information related to problems, including dissolution. The aim of this research is to extend these findings with respect to NIRM imaging and dissolution with the emphasis on understanding the possible sources of variations observed. A number of studies are presented retrospectively to gain an understanding of factors that influence both the images and dissolution. Changing blending time, compression force, particle size and sample ages were shown to affect both the images and dissolution profiles for a number of products. A comparison of the findings from investigative studies on one Pfizer product to a real dissolution example showed similar changes. Correlation of the imaging and dissolution gave product specific results. No general statements could be made about NIRM and dissolution that would apply to any pharmaceutical product. This work shows that it should be possible to use NIRM imaging as a method to control processes at an intermediate stage to provide information about the dissolution of a specific product and potentially allow remedial action to be taken.

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