• PPD_1
  • PPD_2

Preformulation and Formulation

Our start-of-the-art characterization equipment in combination with platform technologies provide clients with outstanding preformulation service. Our formulation development services cover the wide development spectrum from preclinical, first time in human, proof of concept formulation development to generic formulation development and product life cycle management. Along with API manufacture department we can provide integrate CMC services.

Preformulation

Currently, we can provide services including preclinical candidate characterization, enabling formulation development for screening and CMC support service. The following is a list of services we can provide in the preformulation area:

  • Solid State Characterization
    • Thermal analysis (TGA/DSC)
    • XRPD
    • PLM
    • DVS
    • PSD
  • Physicochemical Properties
    • Solubility
    • Stability
    • pKa, LogP/LogD
  • Polymorph Screening
  • Salt and Co-crystal Screening
  • Crystallization & Optimization
  • BioPharmaceutical Classification
  • Excipient Compatibility
  • Solid/Solution Stability
  • Mechanical Property

Formulation

Formulation development services cover early stage formulation for FTIH and POC studies, enabling formulation for solubility enhancement, modified release formulation, generic and LCM products development.

  • Early Stage Formulation for FTIH and POC Studies
  • Tablet, Capsule, Solution, Suspension
  • Enabling Formulation for Solubility Enhancement
    • Nano-particle
    • Solid dispersion
    • Self-emulsifying drug delivery systems
  • Modified Release Formulation
    • Nano-particle Matrix/coated tablets, SR beads
  • Generic and LCM Products Development

Analytical/Stability

  • Analytical method development and validation
  • Impurity identification and quantization
  • Formulation analysis
  • ICH stability study

Instrument Highlight

  • Preformulation
    • TGA,DSC
    • XRPD,PLM
    • DVS
    • PSD
  • Formulation
    • High Pressure Homogenizer, Wetmill, Spray drier
    • High shear granulator, Dry granulator
    • Fluid bed dryer and coator,Autocoator, Extrusion spheronization machine
    • Single punch and Rotary tablet press, Automatic capsule filling machine