We have has developed a customised approach to provide both parallel and high-throughput polymorph screening services.
So we can deliver maximum efficiency, whilst maintaining exceptional resolution, the polymorph screening process utilises a range of 24-96 place crystallisation workflow formats. It is capable of rapidly performing a large number of experiments on milligram amounts of target material, whilst maintaining an emphasis on material behaviour and observation.
Our polymorph screening services include:
- A dedicated solid state research team with a wealth of expertise in polymorph screen and crystallisation problem solving
- Transmission X-ray powder diffraction to discriminate solid polymorphism forms
- The latest two-dimensional detectors for X-ray powder diffraction to enhance data quality
- State of the art, high throughput Raman spectroscopy and µATR-FTIR
Our ultimate goal is to provide support in choosing the optimal crystal form commensurate to achieve your project objectives. We work flexibly to accommodate your project’s own unique requirements. Put simply, tell us your challenge and we’ll do all we can. As a guide, however, the following are typical work programs:
An ideal polymorph screen where the amount of material is limited (100-300 mg) and budget is also a limiting factor. The polymorphism screen is focussed on selecting a limited number of solvents from a given experimental design space, maximising the opportunities for identifying new polymorphic forms whilst recognising there could be a need for solvent change later. Additional material is required for further polymorphism characterisation relative to stability and solubility.
Our standard polymorphism screening is designed to identify as many of the solid forms of your drug substance as possible during a fixed period. We scale up each different polymorphic form, characterise each analytically and determine relative stabilities (thermal analysis and GVS), solubilities and ultimately the form hierarchy. This allows polymorphism form selection and provides a defendable IP polymorphism position. The findings would then lead into a subsequent scale-up and development exercise geared towards producing targeted polymorphic form via a process suitable for manufacture in a GMP environment. Our wealth of experience in crystallisation and process development is a key benefit here.
This is a complete polymorphism screening with a wider range of solvents (more than 100). The use of various technologies (automated Zinsser Crissy platform, parallel manual crystallisations, XRPD, thermal modulation, 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 polymorph screen is to provide a complete basis for intellectual property (IP) coverage and polymorph reporting in a new drug application to the US FDA or national authority equivalent.