Capabilities

Pre-formulation

(drug substance and excipient physical/chemical characterization)

Drug Property Prediction

  • Solubility
  • pH-rate
  • pKa
  • DSC
  • TGA
  • XRD
  • Dynamic Vapor Sorption
  • Particle Size Analysis
    • Laser Diffraction (Mastersizer)
    • PCS/DLS/QELS (Zetasizer)
  • Microscopy – Optical, Raman, SEM
  • Solid State Stability
  • Forced Degradation
  • Surface Tension
  • Critical Micelle Concentration (CMC)

Solid Form Selection

  • Salt Form Screening
  • Polymorph Screening

Advanced Physiochemical Analysis

  • Chemometric analysis of spectroscopic and other physiochemical data
    • Principal components analysis (PCA)
    • Partial least squares (PLS)
  • Single crystal structure determination
  • Quantitation of amorphous content of multiphase mixtures

Formulation

  • Small-scale milling – Retsch
  • Suspensions/emulsions
    • Polytron
    • Microfluidizer
  • Small-scale mixing/granulating
  • Tablets
    • Carver press
    • TDP-5N single station press
    • hardness testing
    • friability/abrasion testing
  • Capsules
  • Enhanced performance formulations
    • Lipid-based formulations
    • Complexation
    • Nano-suspensions

Analytical

  • High Performance Liquid Chromatography (HPLC)
  • Dissolution (Apparatus 1 & 2)
  • Disintegration
  • Gas Chromatography (GC) – headspace, FID
  • Gel Electrophoresis
  • Chiral Analysis
  • Osmolality
  • Viscosity via Cone/Plate Viscometer/Rheometer
  • Water by KF Titration
  • Lipid formulation performance
    • Dispersion/precipitation
    • Digestion/lipolysis

Stability

  • 25C/60%RH
  • 30C/65%RH
  • 40C/75%RH
  • 50C-80C (Stress Testing)
  • 2C-8C (5C)
  • -20C
  • ICH Photostability