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Solid State Services

 Arcinova’s material science team has extensive expertise in solid form screening and selection to identify the most appropriate API form for development. This can be offered both as a stand-alone service or as part of an integrated drug development program. Services include: 

Salt Selection: Poor bioavailability or instability of an API can often be solved/improved by screening different salt forms.  The selection of the most appropriate salt can not only improve the physicochemical properties but identifying all developable salts can strengthen the intellectual property of the API. The choice of counterions is typically based on the pKa of the API, the relevance for the expected dosage form, and the know-how of our experts.   

Polymorph Screening: To meet regulatory requirements, the polymorphic behaviour of an API needs to be assessed and the polymorph chosen for development needs to be fully identified/characterised. Identifying the polymorph landscape can also strengthen intellectual property. 

Amorphous Dispersions: Amorphous forms can have increased solubility and bioavailability in comparison with their crystalline form. However crystalline materials tend to be more stable and amorphous material can recrystallize over time but can be stabilised as an amorphous solid dispersion. Our team of experts can also support this type of study

Crystallisation Development: Supporting the drug substance development team, purification steps can be improved and yield increased by integrating a solid state approach to recrystallization processes

Solid State Characterisation: A range of analytical techniques are available to fully characterise solid state forms including:

  • X-Ray powder diffraction (XRPD)
  • Thermal Analysis (DSC, TGA)
  • Hygroscopy (DVS)
  • Hot stage microscopy
  • Particle size distribution and particle enumeration 
  • Surface Area
  • Solution and Solid State NMR
  • FT-IR
  • Dissolution/disintegration

 

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