Solid Form Solutions Salt, Polymorph and Co-Crystallisation Screening, Crystallisation Development, and Synthetic Chemistry

Solid Form Solutions is a world-leading contract research organisation (CRO) providing the pharmaceutical industry with chemical development services. Our work programmes include:

• Salt screening
• Co-crystal screening
• Crystallisation screening
• Polymorph screening
• Batch process development (scale-up)
• Custom synthesis
• Physical properties and developability testing

Our services can either be used separately to solve specific problems, or in parallel to deliver a larger drug development programme that will seamlessly bring the best synthetic chemistry route to the most developable solid form of a drug molecule.

Our aim is to be flexible, understand our clients’ requirements and deliver workable solutions. Whether our expertise is required to locate a synthetic route or tackle specific problems encountered during drug manufacture, Solid Form Solutions will provide an unrivalled service.

Salt screening and selection

Solid Form Solutions provides a salt screening and selection programme that aims to deliver a number of developable salt forms. Our services are focused on screening a range of counterions based on:

• The pKa of the API
• The market precedence of each counterion
• The available toxicology data of each counterion
• Past salt-screening experience
• Formulation plans

Polymorph screening

Solid Form Solutions provides polymorph screening services that focus on delivering the most developable crystalline form, coupled with a thorough understanding of the polymorphic space surrounding an API. Furthermore, our extensive polymorph screening programme and thorough examination of data ensures better protection of our customers’ intellectual property (IP).

Our unique approach to polymorphism allows us to carry out a very large number of experiments on a very small amount of drug material.

Our study read-out time can be very short (two weeks) without any compromise on data quality, or process space investigated.

The scope of our polymorph screening programme and salt selection studies can be tailored to meet the requirements of our customers.

Co-crystal screening

Solid Form Solutions’ approach to co-crystals is based on over ten years’ experience in the co-crystal sector, coupled with detailed in-house research. The design of our screens incorporates a wide range of methods that include, among others:

• Modelling techniques
• Grinding
• Solvent drop grinding
• Slurrying experiments

As well as aiming to modify the physicochemical, co-crystal screening at Solid Form Solutions is extensive enough to provide our customers with the further IP protection of their APIs.

Crystallisation screening

Often when an API enters into development the solid form is not crystalline. Solid Form Solutions offers an extensive crystallisation service focusing on obtaining a crystalline and easily isolated form of the drug.

Combined with our knowledge of downstream processing Solid Form Solutions will deliver a scalable solution.

Batch process optimisation

Solid Form Solutions’ batch process development service is aimed at developing a bench-scale process into a robust procedure that can easily be transferred to a plant. Solid Form Solutions aims to deliver a controlled process that yields batches of API that exhibit consistent physical properties.

Custom synthesis of novel compounds and intermediates

Our experienced synthetic chemistry team is capable of locating the first route to a drug molecule and delivering a scaled-up, optimised process. Our capabilities include:

• Laboratory synthesis of novel compounds and intermediates
• Expansion of molecular libraries
• Hit to lead optimisation
• Lead compound scale-up for advanced studies
• Extensive analytical support and services
• Synthesis from the milligram scale to pilot plant

Our specialised equipment capability includes:

• Impurity isolation and identification
• Autoclaves for hydrogenation and pressure reaction
• Fractional distillation
• Pilot plant reactors (including continuous flow)
• High-field NMR ¹H, ¹³C, N and ³¹P nuclei (including 2D NMR for full structure elucidation)
• Mass spectrometry (EI, CI, ESI and MALDI)

Whether our synthetic work programmes are used separately, or in tandem with a screening activity, Solid Forms Solutions will deliver the most efficient synthetic chemistry.

Quality control of salt, polymorph and co-crystallisation screening, crystallisation development, and synthetic chemistry

Solid Form Solutions works to the highest possible quality standards, and has a dedicated team to ensure these standards are met. As a part of the studies performed at Solid Form Solutions, clients can have their projects audited by the Solid Form Solutions QA section. Independent of the technical team, the QA section will report regularly to clients on the quality aspects of their project, and provide final sign off.