PRE-FORMULATION EVALUATION

Pre-formulation evaluation
  • Study on basic properties of drugs
  • Screening suitable excipients
  • Formulation design
Technical services
  • Pre-formulation evaluation of new drugs
  • Evaluation of generic non-patent forms or new forms
  • Draft of CTD format application
Technical package
  • Determining BCS classification of drugs
  • Determination the pKa,log P,log D
  • Solid stability study
  • Solution stability study
  • Study on the compatibility of API and excipients
  • Solubility in different solution systems (water. buffers. organic solvents. simulated gastrointestinal fluids)
  • Intrinsic dissolution
  • Study the effects of formulation process parameters on the stability of crystalline forms
  • Toxicology study formula screening