High Pressure Polymorph Screening

Licensing / Collaborative R&D Opportunity

The University of Edinburgh has developed a new method of screening for polymorphs and solvates of drug compounds. The new high pressure screening concept has potential to revolutionise the way polymorph screening is conducted.

We are now offering this unique service to pharmaceutical companies and specialist polymorph screening companies to complement conventional screening programmes for new and existing drug compounds.

The identification of polymorphic (and solvated) forms of drug compounds is of crucial importance because two polymorphs of the same drug may have very different physical properties that affect bioavailability or processibility (eg. tabletting). Regulators therefore demand detailed information about drug polymorphs before granting licenses. The financial consequences of a new polymorph appearing late in production can be very serious, with one recent case estimated to have cost over $500m. Challenges to patents have also been made on the basis of the discovery of a new polymorph.

Conventional polymorph screening techniques typically involve recrystallisations from a wide range of solvents under a variety of conditions and subsequent analysis by calorimetric, spectroscopic, and diffraction techniques. All current screening techniques are designed to operate at ambient pressure, so pressure is not used as a variable.

The Edinburgh process exploits high pressure as an additional dimension in the search for new polymorphs and solvates. A much wider range of conditions can be explored. The systematic variation of high pressures (in the range 500-100,000 atmos.) and temperature can be used to identify known polymorphs and can also produce undiscovered forms. This substantially increases the likelihood of identifying all possible polymorphs/solvates.

Key Benefits

• Increases confidence in physical properties of a new drug
• Improves quality of information presented to regulators
• Eliminates processibility risks
• Reduces risk of competitors discovering new polymorphs
• Reduces options for challenges to patents
• Strengthens market position
• Eliminates costs associated with late discovery of polymorphs
• Uses all possible variables for screening
• Permits high speed exploration of a wide expanse of P-T space

Applications

• Screening of new drugs to find polymorphs and solvates
• Screening of patented drugs to expand IP portfolio
• Can be applied to drugs available as both crystals and powders

Commercial Opportunity

The University of Edinburgh is offering specialist expertise in high-pressure screening. We will be pleased to discuss your requirements and suggest a screening programme utilizing our unique facilities.