Pre-Formulation Development

Pre-Formulation Development

Delivering the very best formulation to the customer is paramount. Challenges exist for each drug candidate; low API availability, particle size, drug bioavailability, solubility, and drug stability should be evaluated extensively. The importance of proper pre-formulation prior to the customer’s formal drug formulation program helps ensure drug development & commercialization success. Generating pre-formulation data is a prerequisite to all development work.

Salt form evaluation & polymorph screening are essential to identifying the best form of the drug substance. Differences in physical and chemical properties of drug substance can impact drug dissolution, physical absorption, bioavailability, pharmacokinetics, and the final manufacturing process. Additionally, identifying & patenting multiple salt forms can establish new IP for the customer and add a competitive edge to your drug product development program.

Pre-Formulation activities:
  • Excipient compatibility
  • Physical properties: flow-ability, compressibility, bulk & tab density
  • Solubility profile (in aqueous & non-aqueous solvents)
  • Partition coefficient
  • Hygroscopicity
  • Solid state stability & forced degradation
  • Crystal Morphology
  • Salt Selection
  • Polymorph screening
  • Particle size evaluation
  • Package & drug compatibility