Pre-Formulation Services

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Pre-formulation activities are one of the most crucial areas of the product development process.  These activities determine which process and delivery methods will provide the most stable form of the drug.  Our scientists evaluate the chemical and physical properties of the target molecule, which provides essential information on the drug’s stability. At PSR we exercise a variety of pre-formulation processes to ensure that your CMO needs are met with comprehensive analysis that is compliant to GMP and other regulatory guidelines: 

Physico-Chemical Characterisation

  • pH- solubility profile and pKa determination
  • Solubility in various aqueous and non-aqueous vehicles
  • pH- Stability Profile
  • Intrinsic dissolution
  • Melting point
  • Hygroscopicity
  • Partition Coefficient
  • Polymorph Characterization Studies
  • Support for Solid state characterization (pXRD, TGA, DSC and Microscopy)
  • Water content

Powder Characterization:

  • Particle size distribution
  • True density and powder envelop density (powder, granules, roll compacted ribbons)
  • Bulk and Tap Density determination
  • Flow Properties

Drug Excipient Compatibility Studies:

Binary or ternary mixtures of API with excipients from various functional categories for example; diluents, binders, glidants, disintegrants and lubricants.