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CrystalGEM
® winner of the 2005 Worldwide CPhI Gold Innovation Award
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CrystalGEM ® - for the efficient, rational crystallisation screening of drugs |
the problem…..
Control of the physical form of a drug substance is recognised to be among the most costly and complex problems facing development and manufacture in the pharmaceutical industry. The formation of solid drug material through crystallisation, or amorphous powder precipitation, is the single most crucial step in the production of most pharmaceuticals and yet it is one of the least well understood processes.
The appropriate crystal or amorphous form is vital for the ensuring that a drug product is of suitable physical, mechanical, chemical and biological profile. Crystal habit, polymorphism, salt formation, solvate formation, amorphism and other features impact upon a wide gamut of manufacturing steps and also carry a considerable commercial advantage through patents.
the solution…..
The efficient screening of
crystallisation is generally hampered by a lack of rational guidance and a paucity of consistent crystallisation data,
leading to considerable wasted effort. CrystalGEM alleviates this inefficiency by providing
a
rational prioritisation of screening conditions so that the most useful data can be
obtained with the least experimentation.
CrystalGEM combines a predictive pattern
recognition approach with an economical experimental crystallisation screening methodology, taking advantage of the
synergy between prediction and experimentation.
The use of
CrystalGEM prediction eliminates wasteful screening while concentrating
effort in those areas of solvent space most likely to yield fruitful information.
The goal of the
prediction can be tailored to the problem in-hand, such as obtaining a
diversity of habits,
seeking a particular form, solvate or process optimisation.
As such,
it is important to recognise that CrystalGEM does not set out to absolutely predict outcomes,
but rather to guide experimental screening and enhance its effectiveness. The prediction
can be undertaken on knowing solely the molecular structure, but can be enhanced by the incorporation of previously
observed data (solubilities, crystallisations etc.) for a compound under study.
"CrystalGEM provides a treasure map to identify where in solvent space one should explore for crystalline forms and then obtains them."
CrystalGEM ® is a registered trademark of Chiralabs Ltd.