Material science testing service by Drug Development Solutions

Manufacturer Drug Development Solutions  |  Available Worldwide
DDS is experienced in the measurement of a materials physical and solid form properties on a wide range of materials including active ingredients, excipients, and formulated products. DDS's expertise covers all stages of development, registration, and manufacturing. DDS's Solid Form Screening and Selection Centre of Excellence builds on their expertise in materials science analysis to offer discovery of high-quality crystalline forms of small molecule development candidates.


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Material science testing service
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DDS's experience includes working with APIs, excipients, process impurities, degradation products, and formulated products. 

Techniques: 

Physical properties testing 

  • Optical and thermal microscopy 
  • Scanning Electron Microscopy (SEM) with Energy Dispersive X-ray (EDX) 
  • Particle sizing (malvern and sympatec: wet and dry methods) 
  • Particle shape by image analysis (QICPIC) 
  • Specific surface area by gas adsorption 
  • Inverse Gas Chromatography – Surface Energy Analysis (iGC-SEM) 
  • Dynamic vapour sorption (DVS)
  • Density (bulk and tapped) 
  • Sieve testing 
  • Porosity 
  • Dissolution 

Solid form characterisation 

  • Powder X-ray diffraction 
  • Differential scanning calorimetry 
  • Thermogravimetric analysis 
  • FT-IR (spectroscopy and microscopy)
  • Thermo-microscopy 
  • Assessment of amorphous / crystalline form 
  • Determination of hydrates, solvates and co-crystals 
  • Crystal structure solution and solid form risk assessment 
  • Thermal analysis (DSC and TGA)
  • Optical and thermal microscopy
  • Dynamic vapour sorption
  • NMR

Solid form screening

  • Efficient, chemistry-led salt screening by experience specialists
  • Polymorph screening
  • Cocrystal design and synthesis
  • Scale up and comprehensive analysis of selected forms
  • Interpretation and recommendation

DDS has extensive experience in working with many product-delivery platforms and formulation types, and supports routine measurements, advanced characterisation, and bespoke method development and validation for all stages of your product development and manufacturing pipeline. 

Applications 

  • Bulk powder handling and processing 
  • Solid form issues such as polymorphism, solvates, salts, and co-crystals 
  • Chemical and physical stability 
  • Dissolution, crystallisation, and segregation 
  • Compatibility between ingredients and packaging 
  • Polymer deformulation and glass delamination 
  • Pilot plant and commercial scale manufacturing 
  • Supplier change and raw materials evaluation studies 
  • Foreign particulates and contaminant identification 
  • Root cause analysis of API and drug product failures 
  • IP, patent litigation, and counterfeits testing 
  • Due diligence activities for in-licensed compounds 
  • Analytical method transfer exercises
  • Raw materials testing