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Crystallization and Polymorphism Development Services Crystallization and Polymorphism Development Services

Crystallization and Polymorphism Development Services

Extensive expertise in crystallization, polymorph screening and development supported by a full suite of infrastructure.

At Aurigene, we have over 20 years of experience in crystallization, polymorph screening and development, salt screening and powder X-ray diffraction.  

We also offer services for studying physical properties like particle size reduction, bulk density, powder flow etc.

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Polymorph Screening

  • Polymorph studies are performed with the API material
  • Solvent screening is performed with following solvents - ICH-3: Ethyl acetate, n- Butyl acetate, IPA, MTBE, MIBK, Acetone, Heptane, n-Butanol, IPAC and 2- Methyl THF, DMSO etc.  
    ICH-2: Acetonitrile, Dichloromethane, Hexane, Methanol, Tetrahydrofuran, Toluene, 1, 4-Dioxane, Di –Isopropyl ether, cyclohexane etc.
  • Detailed solvent screening at different temperatures to classify the solvents as anti or co-solvents
  • Solubility curve generation, identification of Metastable Zone Width (MSZW)
  • Solubility studies are performed with ~95% pure material

Crystallization and Polymorphism

Crystallization experiments are performed to understand the process conditions to get the different morphs. Those are either solvated, non-solvated, hydrated or hemihydrated. Various crystallization techniques are used for screening the solid forms:

  • Cooling crystallization
  • Anti-solvent crystallization
  • Seeding crystallization (Seed point evaluation)
  • Evaporative crystallization
  • Spray drying
  • Agitated thin film dryer

Polymorph-slurry Mediated Transformations

Various forms of the test compounds are subjected to slurry-mediated transformation studies in organic solvents which are having optimum solubility -

  • Slurring media, volume and solid content are appropriately adjusted to make sure that excess solid is present.
  • Time points of the slurry experiments can be decided as per requirements. Solid forms that remained after slurring either in organic solvents or aqueous phase mixtures are separated and subjected to solid-form characterization (PXRD, DSC, and TGA).

Polymorph or Crystallization Process Optimization

  • Crystallization process are optimized with PAT like FBRM (Focused Beam Reflectance Measurement) which shows online particle counts and chord length distributions of the particles and PVM (Particle Vision Microscope) which shows online particle shape
  • Process finalization to achieve desired yield and quality parameters
  • ATFD studies if required, in case of amorphous forms and heat-sensitive materials

Optimization of Filtration, Drying and Particle Size Distribution

  • Filtration and drying studies from a scale-up point of view to optimize the conditions
  • Particle size distribution & milling studies are performed based on the requirement
  • Stress studies for solids (polymorph stability with milling and micronation)
  • Well equipped lab and plant infrastructure with multi-mills, centrifuges, micronizer and ANFDs

We also have a tangential flow filter which is used for separation of compounds based on molecular weights.

Why Aurigene Pharmaceutical Services?

Expertise and experience of 20+ years

Comprehensive infrastructure at lab and plant for full suite of services

State-of-the-art PAT tools and QbD approach to support optimization

Phase-appropriate development approach

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