Products and Services

Preformulation & Material Science

Preformulation & Material ScienceAlbany Molecular Research Inc. (AMRI) is highly experienced at characterizing and modifying a drug substance's physical, chemical, and mechanical properties. AMRI's objective is to help clients assess and choose the best solid form for progression into animal and human dosing trials. AMRI also provides early formulation design and development data, solid state analysis, and crystallization process development and troubleshooting.

AMRI has produced critical scientific data on more than 200 drug substances at stages ranging from preclinical studies, clinical dosing, through commercial. AMRI has served more than 100 customers in the United States, Europe, and Asia representing virtual firms to large pharmaceutical/biotechnology companies with marketed products. AMRI provides a comprehensive array of services that can be customized to match the appropriate stage of drug development. These services include: 

  • Comprehensive solid-state characterization and ongoing support
  • Systematic solubility enhancement for improved dosing performance
  • Systematic salt screen and ongoing support for selection
  • Comprehensive co-crystal screen and ongoing support for selection
  • Preliminary and exhaustive (i.e. IP focused) polymorph screening and ongoing support
  • Crystallization process troubleshooting and optimization with PAT capabilities
  • Early formulation composition design and development, including compatibility, stability and degradation mechanism elucidation
  • Manufacture of GLP supplies
  • Chiral resolution screening
  • Particle size reduction and characterization
  • Physical form stability and quantitation
  • Structural elucidation
  • Foreign particulate identification
  • Spray drying process development
  • Amorphous stabilization

All services can be utilized independently and then fully integrated with discovery, development and manufacturing efforts either within AMRI or an alternate site preferred by the customer.

 
View Preformulation Equipment