Our understanding of quality in pharmaceutical production has evolved significantly over the past decade. The quality-by-design initiative has proved to be a catalyst for those working in the pharmaceutical science community to reconsider established quality testing protocols and focus research on the effect of processing steps on the quality of dosage forms. With clear progress being made in the implementation of continuous processing into industrial practice there has also been a realisation that pharmaceutical engineering and materials sciences need to be better integrated into existing practice. Traditionally, the pharmaceutical development process, the regulatory process and the testing requirements outlined in the pharmacopeias place a strong emphasis on chemical purity and drug content as well as the safety and efficacy of the medicines. It is this context that has dominated the perception of quality in our community and with which we are all familiar. However, it has become increasingly clear that in order to achieve stable manufacturing processes that result in consistent product quality it is now critical to understand the physical characteristics of drug products in far greater detail than is currently the status quo. The microstructure, that is the physical structure at microscopic scale, determines a significant range of critical quality attributes of a dosage form, given their nature as complex multi-particulate mixtures of drug and excipients.
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