Physical form optimization

 

 

Early characterization of Discovery bulks often helps identifying critical milestones to be included into the drug candidate preclinical development plan. Drugabilis regularly performs those measurements on minute bulk amounts.

Thanks to our well-equipped characterization platform, Drugabilis can work on:

  •  Crystallinity assessment
  •  Thermal profile assessment
  •  Hygroscopicity measurement
  •  Hot-stage microscopic observations
  •  Hydrate and solvate identification
  • API physical form stability evaluation under stress conditions
  • Relative stability of polymorphs
  • Crystallization of amorphous API
  • Crystallization process support: find a suitable medium/conditions to produce the selected form, find a suitable medium to purify
  • Set up and validation of polymorphs quantification
  • Physical caracterizations to support freeze drying process (glass transition temperature determination...)


Specific characterization issues related to formulation studies, physical compatibility between drug and excipients, API physical form change upon scale-up or synthetic route modification, proprietary drug delivery technologies and others should be raised to us. They will give Drugabilis the opportunity to design, every time possible, fast and adapted answers.