Formulation Development Strategies from Preclinical PK, GLP Toxicology and Phase I, II, III Clinical Trials to Commercial GMP Manufacturing

Exploratory Formulation Suite

Special Considerations for Discovery/Pre-clinical Stages:

  • Dose requirements for efficacy, PK and toxicology studies vary
  • Routes: IV, PO (solution, suspension, solid), SC, IP, etc.
  • Often with poor solubility and low bioavailability
  • Quick turnaround time
  • Limited amount of material
  • Scalability for future development

Dosage form development for new chemical entities, OTC products, generic products, and 505(b)(2) product candidates.

  • Tablets
  • Capsules, powder-filled
  • Capsules, liquid-filled
  • Oral solutions and suspensions
  • Creams, gels, ointments
  • Injectables
  • Long lasting parenterals
  • Controlled/Sustained release products
  • Pellets
  • Microspheres
  • Lyophilized products
  • Animal study materials

Other Standard Pre-Formulation/Formulation Service Packages:

  • Excipient Compatibility study
  • Solid state properties: particle size, state of hydration, crystal form (third party)
  • Dissolution method development and testing
  • Solubility in simulated gastric fluid (SGF), Simulated intestinal fluids (SIF) and simulated colon fluids (SCF) in Fasted and Fed state
  • Stability studies – short-term, accelerated, forced degradation, ICH photo stability

For more information on our Formulation Development Strategies fill out the contact form below: