Almac

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 formufast^TM 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