Mini Screen

An ideal polymorph screen where the amount of material is limited (100-300 mg) and budget is a limiting factor. The polymorphism screen is focussed on selecting a limited number of solvents from a given experimental design space, in this way maximizing the opportunities for identifying new polymorphic forms whilst recognizing there could be a need for solvent change later. Additional material is required for further polymorphism characterisation relative to stability and solubility.

  Standard Screen

Our standard polymorphism screen is designed to identify as many of the solid forms of your drug substance as possible during a fixed period. We also scale up each different polymorphic form that is deemed suitable for progression via selection criteria, characterise each analytically, and determine relative stabilities (thermal analysis and GVS) and solubility's in order to allow polymorphism form selection and to provide a defendable IP polymorphism position. This would then lead into a subsequent scale-up and development exercise geared towards producing targeted polymorphic form material suitable for manufacture in a GMP environment. Our wealth of experience in crystallisation and process development is a key benefit here.

  Macro Screen

This is a complete polymorphism screen with a wider range of solvents (more than 100). The use of various technologies (automated Zinsser Crissy platform, XRPD, Raman spectroscopy and others) in combination with appropriate computational techniques gives us an exceptional ability to explore and find the useful polymorphic forms of a drug substance. We have designed experiments that cover a wide range of physical conditions and techniques in order to generate as many new solid polymorphic forms as possible. A comprehensive set of analytical techniques would be applied during this screen, as appropriate, in order to systematically characterise all new polymorphic forms identified. The emphasis of this screen is to provide a complete basis for IP coverage and polymorph reporting in a New Drug Application to the USFDA or equivalent to other national authorities.