Preformulation

Preformulation

Preformulation is defined as a stage of development during which the physicochemical properties of the drug substance is characterised and established.  A complete knowledge of the relevant therapeutic and physicochemical properties of the drug enables determination of its proper formulation and delivery method. 

Almac’s strength in pre-formulation comes from the combination of solid state chemistry expertise and formulation know-how.

Preformulation Services for Small Molecules:

  • Determining and assessing the solid state properties
    • Crystallinity
    • Hygroscopicity
    • Particle size, shape & surface area
    • Moisture/ solvent content
  • Chemical stability (solid state and solution state)
  • Biopharmaceutical profiling:
    • pH-solubility profile, pKa and logP determination
    • Permeability and BCS classification
    • Solubility in pharmaceutical solvents
    • Solubility in physiological buffers
  • Formulation development for preclinical and clinical supplies
    • Using our formufastTM screens, smart and fast rationale formulations with improved solubility and bioavailability characteristics can be developed. 

Preformulation Services for Peptides:

  • Peptide structural characterisation by:
    • LC-MS
    • Absorption and fluorescence spectroscopy
    • Circular dichroism spectroscopy
    • NMR
    • Raman
  • Peptide chemical stability (solid state and solution state)
  • Preclinical formulation development:
    • Effect of pH
    • Buffer concentration and buffer type
    • Surfactants
    • Complexing agents like cyclodextrins
    • Polymers and cosolvents
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