Preformulation

From stand-alone discovery support to full development program, we can provide custom and need-specific solutions that include physico-chemical profiling,degration, stability study, optimization of existing formulations, life cycle management and development.

Preformulation is the stage during which the physiochemical property of the drug substance is characterized. A complete understanding of the relevant drug compound is necessary for proper formulation and delivery of the drug.Preformulation assays include salt form optimization, polymorph screening and compatibility. The main objective is to maximize the drug potential of the compound by enhancing the stability.

Drug Preformulation studies include determination of:

  • Physicochemical properties
  • Aqueous and pH solubility, organic solvent solubility
  • Dissociation constants
  • Hygroscopicity and Lipophilicity
  • pKa, partition coefficients, and tissue
  • distribution coefficients
  • Thermal properties
  • Moisture content
  • Polymorphism
  • Particle size morphology
  • Drug-recipient compatibility