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Preformulation

LATITUDE provides services for preformulation evaluation of drug substances in both solution phase and solid state.

Our solution phase program focuses on:

  • Solubility in pH buffers (pH-solubility profile)
  • Solubility in pharmaceutically useful solvents
  • Drug solubilizer screening
  • Determination of ionization constants
  • Determination of partition coefficients
  • Drug-excipient compatibility

The solid state program emphasizes on:

  • Salt selection
  • Morphology study
  • Hygroscopicity evaluation
  • Thermal characterization
  • Particle size and size distribution
  • Powder density, flowability and compressibility
  • Drug-excipient compatibility

At LATITUDE, we have developed unique methods in performing the preformulation tasks with a minimum quantity of drug substance. Typically, a comprehensive preformulation evaluation can be completed, including analytical HPLC method development, using less than 1-2 grams of the drug substance.



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