How we support the Drug Development industry

Discovering a potent and highly selective API is, of course, only part of the story of creating a new medicine. Careful consideration of the appropriate dosage form for the patient is essential for effective treatment. Of course, different dosage forms present a wide range of technical challenges, with product solubility and long term stability paramount to the ultimate success of the therapeutic treatment. Specific pharmaceutical formulation challenges include investigating the dissolution process, particle size, drug and excipient phase behaviour, along with the effects of polymorphism, solubility and oxidation among others.

Enteral Formulations

  • Investigate polymorphism and co-crystal formation in APIs;
  • Understand changes in formulations under varying conditions e.g. pH, temperature;
  • Investigate stability of APIs under manufacturing conditions.

Parenteral Formulations

  • Analyse lyophilised materials undergoing dissolution process;
  • Characterise complex phase behaviour in formulations;
  • Understand behaviour of excipients under varying conditions and compositions;
  • Root cause analysis to help resolve formulation issues;
  • Characterisation of both large and small molecule formulations.

Topical/Inhaled Formulations

  • Microstructural investigations of powders, dispersions, emulsions, cream, foams etc.;
  • Understanding variations in behaviour of excipients with varying batch or storage conditions;
  • Direct imaging of drug delivery devices e.g. inhalers.

Manufacturing

  • Assess manufacturing issues with direct imaging such as cracking and granulation in tablets, bubbles in capsules;
  • Chemical identification of precipitates and impurities in pharmaceutical formulations using spectroscopy and diffraction.
  • Non destructive imaging of delivery systems e.g. auto-injectors
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Investigating novel drug delivery platforms

AstraZeneca used high-energy X-ray tomography at Diamond Light Source to visualise how injected drug formulations disperse in tissue—advancing the design of long-acting therapies.

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