Analytical techniques for assessing the quality of the formulation. Research and characterization of physico-chemical parameters of the formulation, excipients and the drug. Stability study and interactions between the formula components. Polymorphism and residual impurities analysis. Research of degradation products. Analysis of the particle size distribution.
Study of solubility in aqueous and organic media
Excipient compatibility study
Determination of the partition coefficient
Intrinsic Dissolution
Thermal analysis DSC / TG and humidity
Study of the primary packaging and stability
Photostability study
Characterization of particle size and distribution
Preliminary assessment of the suspensions and emulsions stability
Permeation study and percutaneous release
Physical stability of the formulation
Polymers analysis
Main equipment:
HPLC with UV, FLD and DAD detectors • Spectroscope (FTIR) • Stability Chamber • TG • DSC • Scanning electron microscope • Sputter Leica EM (gold plating) • DLS • Karl Fisher • Zeta sizer • Nano Sight® • Rheolaser • Zeta Plus • Thurbiscan • Chromatography of polymer • Mini incubator • Rotaevaporator • GTB (angle of repose)