The Process Analytical Technologies (PAT) initiative of the US Food and Drug Administration (US FDA) has established a framework for the development of imaging techniques to determine the real-time distribution of mixture components during the production of solid dosage forms. This study, which is the first in a series of two parts, uses existing mixing indices and a new criterion called the " percentage of homogeneity" (H%) to assess image homogeneity. Image analysis techniques use feature extraction procedures to extract information from images subjected to treatments including colour segmentation and binarization. The surface distribution of components was determined by macropixel analysis, which splits an image into non-overlapping blocks of a preset size and calculates several statistical parameters for the resulting divisional structure. Such parameters were used to compute mixing indices. In this work, we explored the potential of image processing in combination with mixing indices and H% for assessing blending end-point and component distribution on images. As a simplified test, an arrangement of binary and ternary systems of coloured particles was mixed collecting at-line multispectral (MSI) and non-invasive RGB pictures at preset intervals. © 2012 Elsevier B.V..
|Journal||Journal of Pharmaceutical and Biomedical Analysis|
|Publication status||Published - 1 Nov 2012|
- Image analysis techniques
- Macropixel analysis
- Mixing indices
- Percent homogeneity
- Process analytical technologies (PAT)