Multivariate wavelet texture analysis for pharmaceutical solid product characterization.
The application of multivariate wavelet texture analysis (MWTA) is presented and discussed as it is applied to three different types of pharmaceutical materials: (a) tablet cores, (b) wet granules and (c) controlled release tablets. The application of MWTA is initially proposed as a quantitative replacement to the human visual judgment of the textural appearance of the different materials. In all cases, the metrics obtained with MWTA agree with visual assessment on the progression of textural features such as erosion and surface roughness. This work further demonstrates that MWTA also represents a useful tool to increase the understanding of the manufacturing process, as it provides diagnostics to relate process parameters with textural features of the material that are difficult or costly to measure otherwise (such as granule size for wet material or surface appearance for a controlled release product). MWTA is also presented as a potential tool for real-time release for those cases where the textural features can be proven to provide accurate enough predictions of the final product performance; as shown here with the obtained prediction of dissolution from the controlled release tablet using the texture of the product as an input.
García-Muñoz
Salvador
S
Pharmaceutical Development, Pfizer Global R&D, Groton, CT 06340, USA. salvador.garcia-munoz@pfizer.com
Carmody
Alan
A
D002626:Chemistry, Pharmaceutical / Q000379:methods*; D015999:Multivariate Analysis; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry*; D013608:Tablets, Enteric-Coated
D004364:Pharmaceutical Preparations; D013608:Tablets, Enteric-Coated