Solid Form Screening Services

Understanding the solid form options early in the development of an investigative pharmaceutical candidate is critical for efficient progress towards clinical success and ensuring robust and consistent production of the most optimised version for in-vitro assessment.

Our comprehensive Materials Science capabilities allow us to offer a Solid Form Screening and Selection service for viable crystalline versions including salts, cocrystals and polymorphs.

Our experienced team are experts in the design and completion of efficient solid form screens based on client needs and objectives, and then in the interpretation of results and observations in the context of candidate development phase. This then informs the recommendation of an optimal version and form for further studies.

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DDS Solid Form Screening and Selection Centre of Excellence

Solid Form Screening and Selection Centre of Excellence

Our Solid Form Screening and Selection Centre of Excellence builds on our expertise in Materials Science to offer the discovery and /or optimisation of crystalline forms of small molecule development candidates.

The centre is supported by expert and experienced materials science analysis using a wide range of analytical techniques operating to the highest quality standards.

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Your Trusted Partner for Solid Form Screening Services

Our team has extensive experience in synthetic and medicinal chemistry. From an initial kick-off discussion to establish and understand your specific needs and objectives, our experts will use a chemistry-led approach to design bespoke screening protocols with the aim of maximising hit rate while minimising compound requirement. Selected forms would be scaled-up, fully characterised and compared to ensure the smoothest path into the next stage of development.

We offer Solid Form support throughout the drug development process, from candidate selection and efficient processing through to ‘fit for purpose’ formulation and toxicity studies scale up, API and formulated drug substance manufacture.

Speed up your small molecule drug development programme

We have developed a chemistry led approach which maximises hit rate of lead compounds whilst minimising compound requirement.

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Our Solid Form Screening Services

  • Bespoke salt screening by experienced specialists designed to meet your objectives
  • Polymorph screening
  • Cocrystal screen design and discovery 
  • Scale up and comprehensive analysis of selected forms
  • Interpretation and recommendation
Solid Form Screening Services

We offer the following services for Solid Form Screening:

 

Salt Screening and Selection in Drug Discovery and Development.

Where a candidate molecule has one or more ionisable centres, salt screening can be a key step in drug development. Dramatic improvements in solubility and bioavailability in biological media have been achieved without the need for more complicated formulation options. Drug Development Solutions can perform one or more salt screens to accomplish this in conjunction with other desirable properties for an Active Pharmaceutical Ingredient (API) or Investigational Medicinal Product (IMP) such as solubility, stability and handleability.

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Polymorph Screening Services in Pharmaceutical Compounds

It is a regulatory requirement that the polymorphic landscape of any approved pharmaceutical be well understood and controlled.

It is therefore important that the most stable and optimised form is identified and produced early in Pharmaceutical Development. This reduces the risk that unexpected adverse events, such as batch to batch variability, instability, processing issues and increased hygroscopicity, may occur later.

Drug Development Solutions can perform screens to investigate and understand the solid-state polymorphism associated with your compound. Using a variety of techniques, we aim to identify and characterize all major polymorphic forms as well as any hydrates and the potential for solvation of your API.

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Cocrystal Screening and Selection

At Drug Development Solutions we are experts in cocrystal screening.

We provide cocrystal screens for sponsors where the molecule has no ionisable centre or suitable salt forms have not been found and where structural analysis indicates this may be a worthwhile route to explore.

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Crystallisation Development

Often when an API enters into development the solid form is not crystalline. We offer an extensive crystallisation service to assist you with your crystallisation and screening and deliver a scalable solution.

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Solid Form Services - 
Characterisation techniques offered

  • Powder X-ray diffraction for crystallinity and polymorph identification
  • Thermogravimetric analysis for hydrates and solvate identification
  • Differential scanning calorimetry for purity and melting point
  • Optical, Scanning Electron Microscopy and thermal microscopy
  • Dynamic vapour sorption for hygroscopicity and effect of humidity
  • NMR for chemical integrity
  • Particle sizing
  • High Performance Liquid chromatography if requested for solubility in water and biorelevant media

Why chemistry-led design brings the greatest value to pharmaceutical development

All candidates for development as pharmaceuticals will require screening to identify which solid forms are available whether free compound, salt, cocrystal, hydrate, or a polymorph of these.

Editorial by Kim James, Solid Form Expert, Drug Development Solutions

Read the article here