A process analytical technology for characterising.. (CRYSTAL-VIS)
A process analytical technology for characterising the physical properties of crystals
Date du début: 1 janv. 2014,
Date de fin: 31 déc. 2015
"An active pharmaceutical ingredient (API) is the substance in a pharmaceutical drug that has the pharmacological activity. The crystallisation process is a critical step in the API manufacturing process and for delivering “product” in its final form, with some 70 % of products going through a crystallization step at some point in their manufacture. The size and shape of the crystals are important to the quality and safety of the product, and variation during crystal growth can have a significant effect on final product behaviour such as blend homogeneity, drug absorption rates, product robustness, etc. Controlling the final shape and size of crystal is a major challenge to manufacturers, particularly as it is often difficult to measure on line and the crystallisation process is often nonlinear in behaviour. Moreover, API molecules are becoming increasingly complex, tending to reduce aqueous solubility, in turn reducing bioavailability and often leading to difficulties in crystallisation.The ability to understand the crystallisation process would be a breakthrough for API manufacturers and would allow for control of the crystal phase, in terms of purity, particle size and shape, for high quality, safe products. Moreover, the crystal structure during crystal growth is a direct indicator of process end point and if more closely tracked could lead to leaner process development and process monitoring. Moreover, an understanding of crystallisation is fundamental for reducing the incidences of failure in the development of new molecular entities.A group of industrial SMEs have come together to outsource the development of a revolutionary imaging-based physical characterisation device that will provide the API industry with real-time information of all crystal physical characteristics in-line in a crystallisation process, thereby allowing this critical of processes for the behaviour of the end-product to be controlled"
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