Co-Processing of Amorphous Solid Dispersions via Co-precipitation

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Overarching scopeTo prepare drug forms in the amorphous state to increase bioavailability, improve dissolution, flowability and stability for continuous manufacturing via anti-solvent co-precipitation. Why? Amorphous pharmaceuticals are more soluble in the body than crystalline forms. Industry interest in amorphous drug forms allows for the co-precipitation method to be utilised. Co-precipitation reduces the chances of API destruction which is more common in HME and spray drying where high temperatures are used. How?Initially, scoping out the instrumentation by benchmarking against a model crystalline system will allow for an understanding of the behavior of the system. Mixing speeds, sheer rates, temperatures, flow rates, different solvents will be used to test the reproducibility, accuracy, and precision of the equipment. This data will be used to expand to a well-studied polymer. After initial testing a well understood polymer-API system will be realised. This will allow the ability to move on to other polymer-API systems that are not yet realised. At all stages, processed materials will be characterised via XRPD, DSC, particle sizers, electron microscopy (solid state, physical properties). FinallyCo-amorphous system prediction, using data from DDMAP work packages 1-3 we can predict optimal process/composition selection for manufacture of stable ASDs.