Formulation Development

Pre Formulation Studies


Characterization of the Active Pharmaceutical Ingredient (API) is critical for designing a successful formulation approach. DRF can evaluate the characteristics of your active compound, conduct small-scale studies to understand key parameters around solubility and stability, and perform excipient compatibility studies to identify the right ingredients to enhance your APIs performance across a variety of dosage forms. Further, DRF has brought on-board various technologies to control and reduce particle size, which among other things, can greatly enhance the bioavailability of your finished product

Capabilities

  • Polymorph screening and selection
  • Salt form selection
  • Crystalline properties
  • pH solubility and stability
  • Solid-state and solution-state stability
  • Photostability
  • pKa and partition coefficient determination
  • Hygroscopicity
  • Morphology assessment
  • Solubility studies
  • Intrinsic dissolution
  • Excipient compatibility
  • Leachables and Extractables studies
  • Flowability
  • Particle size determination by laser lights
  • Container – active pharmaceutical ingredient (API)  interactions

Equipment/ Technologies

  • Thermal analysis: DSC (Differential Scanning Calorimetry), TGA (Thermogravimetric Analyzer)
  • Dynamic Vapor sorption/desorption
  • NMR (Nuclear Magnetic Resonance)
  • pXRD (X-Ray Diffraction)
  • FT-IR (A Fourier Transform Infrared) spectrometer Capillary Electrophoresis
  • SEM (Scanning Electron Microscopy) and TEM (Transmission Electron Microscope)
  • Potentiometer
  • Hot-stage Microscopy
  • Laser light diffraction Particle size analyzer
  • Intrinsic dissolution
  • Head Space GC analyzer