Spray drying is a commonly used technology to formulate and develop new and improved drugs by producing dry powders from solutions or suspensions. It is useful for numerous drug development applications from producing dry API powders to modifying release rates of poorly and/or highly soluble compounds.  CritiTech Particle Engineering Solutions offers spray drying services from proof-of-concept through Phase II cGMP production for aqueous and organic solvent soluble materials.

CritiTech Particle Engineering Solutions’ custom spray drying equipment (“SD30 Spray Dryer”) can produce average particle sizes in the same range produced by a GEA Mobile Minor, typically 5-80 microns, at a slightly faster production rate.  However, the SD30 Spray Dryer can also produce average particle sizes of less than 5 microns, which offers our clients opportunities to manufacture a wider range of drugs, especially pulmonary drugs (i.e. the “sweet spot” for pulmonary delivery is an average particle size of 1-5 microns).  Manufacturing parameters from a Buchi or Mobile Minor are easily transferred to CritiTech Particle Engineering Solutions’ SD30 Spray Dryer.  CritiTech Particle Engineering Solutions has successfully scaled-up production of numerous materials from its Buchi B-290 to its SD30 Spray Dryer, which can produce kilogram quantities on a daily basis.

Features of Spray Drying Technology

  • Spray-dried dispersions (amorphous API + polymer)
  • Spray-dried precipitates (crystalline or amorphous API alone)
  • Spray from aqueous or organic solvent systems
  • Non-potent API
  • Non-cytotoxic API
  • Potent API
  • Cytotoxic API (dedicated room, equipment, and air handling system)
  • Cytotoxic and non-cytotoxic cGMP materials produced in separate facilities
  • Continuous processing
  • Develop multiple formulations with grams of API
  • Milligrams to hundreds of kilograms production scale
  • Data from Buchi or Mobile Minor can be easily transferred to CT PES

Benefits of Spray Drying Technology

  • Bioavailability enhancement of poorly soluble drugs (BCS Class II and IV)
  • Applicable for peptides and biologics
  • CritiTech’s single pass nitrogen systems ideally suited for drugs
  • Oxygen sensitive
  • Vulnerable to abrasion or shearing
  • With high crystal lattice energy
  • Potential to improve pharmacokinetics
  • Can be utilized as a LCM tool for a reformulated and improved 2nd generation product
  • Particles engineered for multiple routes of delivery
  • Scalable and reproducible