The impact of pharmaceutical materials properties on drug product quality and manufacturability is well recognised by the industry. An ongoing effort across industry and academia, the Manufacturing Classification System consortium, aims to gather the existing body of knowledge in a common framework to provide guidance on selection of appropriate manufacturing technologies for a given drug and/or guide optimization of the physical properties of the drug to facilitate manufacturing requirements for a given processing route. Simultaneously, material scientists endeavour to develop characterisation methods such as size, shape, surface area, density, flow and compactibility that enable a stronger understanding of materials powder properties. These properties are routinely tested drug product development and advances in instrumentation and computing power have enabled novel characterisation methods which generate larger, more complex data sets leading to a better understanding of the materials. These methods have specific requirements in terms of data management and analysis. An appropriate data management strategy eliminates time-consuming data collation steps and enables access to data collected for multiple methods and materials simultaneously. Methods ideally suited to extract information from large, complex data sets such as multivariate projection methods allow simpler representation of the variability contained within the data and easier interpretation of the key information it contains. In this review, an overview of the current knowledge and challenges introduced by modern pharmaceutical material characterisation methods is provided. Two case studies illustrate how the incorporation of multivariate analysis into the material sciences workflow facilitates a better understanding of materials.
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Guest Editors: William C. Stagner and Rahul V. Haware
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Ferreira, A.P., Gamble, J.F., Leane, M.M. et al. Enhanced Understanding of Pharmaceutical Materials Through Advanced Characterisation and Analysis. AAPS PharmSciTech 19, 3462–3480 (2018). https://doi.org/10.1208/s12249-018-1198-6
- pharmaceutical materials characterisation
- manufacturing classification system
- multivariate analysis
- data management