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 – API + polymer/excipients
  • Spray-dried powders – API alone
  • Spray dry from aqueous or organic solvent systems
  • Single pass nitrogen system is ideally suited for producing the following types of drugs
    • Drugs that are oxygen sensitive
    • Drugs that are vulnerable to abrasion or shearing
    • Drugs with high crystal lattice energy
  • Non-potent API (dedicated room, equipment, and air handling system)
  • Non-cytotoxic API (dedicated room, equipment, and air handling system)
  • Potent API (dedicated room, equipment, and air handling system)
  • Cytotoxic API (dedicated building, equipment, and air handling system)
  • Milligrams to hundreds of kilograms production scale
  • Fully validated cGMP equipment

Benefits of Spray Drying Technology

  • Enhances bioavailability of poorly soluble drugs (BCS Class II and IV)
  • Modified release rates of highly and poorly soluble compounds
  • Enables improved pharmacokinetics and multiple routes of delivery
  • Development of multiple formulations with grams of API
  • Enables processing of peptides and biologics
  • Particles can be engineered to improve pharmacokinetics and for multiple routes of delivery
  • Scalable and reproducible
  • Can be utilized as a LCM tool for a reformulated and improved 2nd generation products
  • Conditions from Buchi B-290 or Mobile Minor systems can be transferred to CT PES