Preformulation Testing

you wouldn't build a house on un-tested foundations, so why embark on a drug development process before understanding the properties of your lead compound?


At Kuecept, we are highly experienced in physico-chemical and biopharmaceutical profiling of new Active Pharmaceutical Ingredients (APIs); we routinely assist early-stage companies to evaluate the solution and solid-state properties of their lead candidates and use this information to make informed decisions to optimize further preclinical product development.

In addition, these studies aim to highlight potential physical / chemical stability and processing issues that may occur downstream and used at the correct time, can help de-risk development candidates and choose the correct path for formulation development activities.

 

Materials Testing

  • Solid-state profiling and determination of critical material attributes (crystallinity, polymorphic form, melting-point / recrystallisation temperature, residual solvent / moisture)
  • Hygroscopicity determination and hydrate formation / conversion / stability
  • Particle characterisation (size, shape, morphology, surface area, porosity, surface tomography)
  • pKa and dissociation equilibrium (experimental and in silico prediction from structure)
  • Partition and distribution coefficient as a function of pH (LogP/D)
  • pH-solubility profiling
  • Solubility determination in biorelevant media (FaSSGF/FeSSGF, FaSSIF/FeSSIF, FaSSCoF, SLF, blood plasma)
  • Polymorphic screening and salt selection
  • Crystal structure elucidation
XRD

ADME/T Profiling

Through our internal capabilities and partner network, Kuecept offers an extensive suite of in silico and in vitro absorption, distribution, metabolism, excretion and toxicity/pharmacokinetic (ADMET) assay solutions:

  • CYP450 Inhibition Assay
  • Microsomal Metabolic Stability Assay
  • Hepatocyte Metabolic Stability Assay
  • S9 Metabolic Stability Assay
  • Plasma Stability Assay
  • Blood Stability Assay
  • Plasma Protein Binding Assay
  • Blood Partitioning Assay
  • MDR1-MDCK Permeability Assay
  • Caco-2 Permeability Assay
  • Haemolysis (Osmotic Fragility) Assay
preformulation

 

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