Supercritical Precipitation (SCP)

Our proprietary and proven Supercritical Precipitation platform can move you beyond micronization. It’s about more than size.

CritiTech’s Supercritical Precipitation technology is a patented and successful drug delivery platform that moves beyond conventional dissolution improvement theory that smaller is better. We can modify particle characteristics such as size, shape and polymorph by adjusting the properties of the feed solutions and operating parameters in our systems:

  • Solvent selection
  • API concentration
  • Temperature
  • Pressure
  • Solution/feed flow rate
  • scCO2 flow rate
  • Ultrasonic energy
  • Nozzle configuration

Typical Particle Characteristics of Supercritical Precipitation

  • Small Physical Particle Size DV₅₀ (Volume) = ~ 0.5 to 5µm
  • High Specific Surface Area = >20m²/g
  • Low Bulk Density = <0.1g/cm³
  • Uniquely shaped and structured particles formed in a narrow size range
  • Particles are pure drug – no excipients necessary but can add them if desired
  • Particles are normally crystalline but can sometimes be different polymorphs or amorphous if desired
  • Particles designed to be larger, easier to manipulate particles with the surface area and drug release characteristics of much smaller submicron particles – an alternative to other micronization technologies without added excipients

Features of Supercritical Precipitation

  • Ideally suited for oxygen and water sensitive compounds
  • API alone or with excipients
  • Potent API (dedicated room, equipment, and air handling system)
  • Cytotoxic API (dedicated building, equipment, and air handling system)
  • Non-potent API (dedicated room, equipment, and air handling system)
  • Non-cytotoxic API (dedicated building, equipment, and air handling system)
  • Near ambient processing temperatures
  • Continuous manufacturing process
  • Milligrams to hundreds of kilograms
  • Fully-validated cGMP equipment

Benefits of Supercritical Precipitation

  • Unique particle characteristics (compound dependent)
    • Particles ranging from 250 nm to 10 µm
    • Exponential increase in surface area resulting in improved dissolution and bioavailability
    • Narrow particle distribution range
    • Amorphous, crystalline, or co-crystalline materials
    • Improved flow-ability
  • Bioavailability enhancement of poorly-soluble drugs
  • Enables improved pharmacokinetics and multiple routes of delivery
  • Does not induce electrostatic charges into particles
  • Virtual eliminates residual solvents – no secondary drying required
  • Development of formulations with grams of API
  • Scalable and reproducible 
  • Can be utilized as an LCM tool for reformulated or improved next generation drugs

CritiTech Supercritical Precipitation Systems

CritiTech
RC612

CritiTech
RC612B

CritiTech
cFPC-411

CritiTech
FPC-716

Supercritical fluid CO2BatchBatchContinuousContinuous
Approximate production scale200 mg – 5 g200 mg – 5 g~75 g/hr~75 g/hr
Proof of Concept/Development
cGMP Manufacturing
Non-Cytotoxic
Cytotoxic