RESEARCH AND DEVELOPMENT

The R&D Team is made of five qualified scientists (industrial pharmacists and chemists), with deep knowledge in pharmaceutical powders technologies and competencies in process development and technology transfer to industrial scale. Their main activities are focused on:

 

  • Physical characterization of pharmaceutical powders
  • Feasibility micronization trials, starting from about 1 g of powder
  • Process development with a QbD approach, by applying an appropriate DoE study
  • Process scale-up to industrial level and optimization trials
  • PSD method development and its transfer to QC
  • Development of new technological application of micronization process

The R&D facility includes:

 

  • A micronization room and an analytical lab, with separate personnel and material flows, provided with a dedicated HVAC system and the application of room pressure cascade criteria
  • A rigid isolator for OEB 5 products and a flexible isolator, to guarantee proper containment conditions in micronization
  • Spiral jet mills of different size (MC20-50-100-150) and a small scale opposite jet mill (JS100)
  • Application of cryogenic conditions (down to -60°C)
  • Instrumentation in place for continuous monitoring and recording all operating process parameters to facilitate scale-up
  • A dedicated analytical lab, equipped with instrumentation for powder characterization

INTERNAL ANALYTICS CAPABILITIES

  • Laser Diffraction Helos-Sympatec
  • Laser Diffraction Mastersizer 2000-Malvern
  • Laser Diffraction Mastersizer 3000-Malvern
  • Laser Diffraction S3000-Microtrac
  • Image analyzer Morphologi G3SE-Malvern
  • Optical Microscope
  • Melting Point Instrument
  • FT/IR
  • UV/Visible Spectrophometer
  • HPLC and UHPLC
  • Karl Fischer instrument
  • Differential Scanning Calorimetry DSC1-Mettler
  • Dynamic Vapor Sorption Q5000 SA-TA Instrument

ANALYTICAL SERVICES IN COOPERATION WITH EXTERNAL QUALIFIED LABORATORIES

  • Power X Ray Diffraction
  • Specific Surface Area (BET)
  • SEM
  • ICH Stability studies
  • Dissolution Test