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21

Settembre 2017

Advanced characterization techniques applied to solid forms: from API to drug product

Onecrucial consideration that both novel API’s as well as generic drugs share isthe selection of their solid form. Regardless of whether the API is a free acidor a base, a salt or a cocrystal, choosing the right solid form can beparamount to both the activity and safety of a medicine. Aspects such asbioavailability, stability and flowability, among others, can be highlyinfluenced by the API solid form. Therefore, at any stage from drugdiscovery to commercial manufacturing, the ability to analyse and characterize thesolid form of an API or a semi-formulated or formulated drug is key.

The aimof the workshop is to show how at each stage of the drug development andmanufacture journey we can use a wide range of routine as well as advancedanalytical techniques. A number of state-of-the-art analytical techniques willbe reviewed, with special emphasis given to some more advanced andsophisticated ones. Although available, these techniques sometimes areunderused, perhaps due to their apparent complexity and unfamiliarity. Oneobjective is to review the best fit for purpose techniques in each stage,showing how less commonly used techniques can often make a difference andprovide a solution to an apparently difficult problem.

Practicalexamples will be discussed, showing how advanced solid state analytical techniquessuch as synchrotron X-ray diffraction, for example, can be applied to theroutine analysis of APIs, formulations and final drug products. The combineduse of advanced microscopy analyses (i.e. PLM, SEM, AFM or TEM) during drugdevelopment and manufacture will also be presented.

The overallaim is to present the audience with a toolbox of solid state characterization standardand advanced analytical techniques that can be used on a daily basis, not only ina pharmaceutical development department but also at the commercial manufacturinglevel. To put the techniques into context, an initial walkthrough of some basicsolid-state concepts and regulatory aspects will also be presented.

[Workshop in collaborazione con ENANTIA]

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Preadesione al corso: Advanced characterization techniques applied to solid forms: from API to drug product

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