SAFC Pharma™ - Pharmorphix™ Services has developed a proprietary capability which enables us to rapidly find a range of pharmaceutically acceptable salts.
Starting with the experimental analysis of pKa's, the drug indication and delivery method, counter ions are selected accordingly and an approach to experimentation is devised.
This platform consists of a number of automated crystallisation arrays with the capability to handle many experiments in parallel and arrays which can manage quantities of product varying from milligram to gram.
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All solid products from these experiments are then analysed by X-ray diffraction and other complementary techniques, with the positive hits from this process moving forward to a more comprehensive study.
The characterisation of the crystalline hits from the screening process is determined by a suite of analytical techniques. These allow us to establish the chemical and physical stability, solubility and other properties of the identified forms.
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X-ray crystallography |
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Thermal methods - DSC, TGA, hot-stage microscopy and variable-temp XRPD |
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Optical microscopy |
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Stability - dynamic moisture sorption. |
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Spectroscopy - NMR and FTIR |
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Solubility, dissolution and purity by HPLC. |
The aim of the selection process is to fully characterise the properties of the salt form through an iterative ranking process which finally leads to the selection of the preferred candidate.
Once the preferred solid form has been chosen, our experience in process chemistry allows us to identify protocols for reliably producing the desired final form on scale up.
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