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Pre-Clinical Formulation Manufacture

At this stage the program is ready to move forward to preparing the dose form that is to be used in the Pre-Clinical trial.

For more information:
Call: +44 1274 326073
Email: answers@agenda1.co.uk

pre-formulation-assessment

Pre-Formulation Assessment

The focus here moves from API to a dose form that can be trialled in pre-clinical studies. But, before moving to that Pre Clinical Formulation work, we can provide support that can help you make your decisions faster, and more precisely.

Initially we support by providing a Full Characterisation of the API which includes NMR, XRPD, DSC, TGA, DVS, FTIR, Hot Stage and Polarised Microscopy, Aqueous Solubility, also pH and a simple HPLC analysis to begin to understand purity. This starting data provides a benchmark to begin to understand the material “as is” and where the key challenges lie, and how they can be addressed. All of this work is carried out by our scientists within GMP-controlled laboratories.

Also at this stage a limited version of Agenda1’s Excipient Solubility Screen can be used to provide an understanding of the extent of solubility of the API in a range of solvents and excipients. This also gives an indication of the possible ways any problems can be resolved. Other work at this stage will be to investigate the physical and chemical stability of the API looking at techniques such as XRPD, FTIR, Raman, NMR and HPLC to determine changes in the API. We are also able to look at dissolution, permeability and solubility in a range of conditions which mimic physicochemical conditions.