The Supercritical Precipitation Technology (SCP Technology) is a proprietary technology developed by CritiTech Particle Engineering Solutions that is used to modify particle size, shape, and crystalline phase of API’s.  The SCP technology takes advantage of a supercritical carbon dioxide anti-solvent precipitation technique combined with a proprietary homogenization process to produce unique drug particles.  These unique particles can be used to modify and improve the dissolution rate, efficacy, toxicity, dosing, delivery, and flowability of compounds that are difficult to formulate.  The SCP Technology has been exclusively licensed for use in the fields of oncology and topical dermatology.  Four drugs have been developed with the SCP Technology that are currently being tested in a total of six Phase II trials.

Features of Supercritical Precipitation Technology

  • Near ambient processing temperatures
  • Water and oxygen free processing environment
  • API alone or with excipients
  • Amorphous, crystalline, or co-crystalline materials (drug dependent)
  • Non-potent API
  • Non-cytotoxic API
  • Potent API
  • Cytotoxic API (dedicated room, equipment, and handling system)
  • Cytotoxic and non-cytotoxic cGMP materials produced in separate facilities
  • Continuous processing
  • Proof of concept through Phase II clinical production

Benefits of Supercritical Precipitation Technology

  • Unique particles ranging from 250 nanometers to 10 microns
  • Narrow particle distribution range
  • Exponential increase in surface area and dissolution rate
  • Bioavailability enhancement of poorly soluble drugs (BCS Class II and IV)
  • Improved pharmacokinetics
  • Particles engineered for multiple routes of delivery
  • Can be utilized as a LCM tool for a reformulated and improved 2nd generation product
  • Virtual elimination of residual solvents (no secondary drying required)
  • System ideally suited for oxygen and water sensitive compounds
  • Does not induce electrostatic charges into particles
  • Scalable and reproducible
  • Milligrams to hundreds of kilograms

Case Studies

CT-0610

Unprocessed

Processed

Number Distribution
(micrometers)
Volume Distribution
(micrometers)
Unprocessed Processed Unprocessed Processed
D10 0.48 0.40 4.94 0.49
Mean 0.83 0.55 8.46 0.74
D90 1.46 0.77 14.41 1.25

CT-0376

Unprocessed

Processed

Number Distribution
(micrometers)
Volume Distribution
(micrometers)
Unprocessed Processed Unprocessed Processed
D10 1.81 0.61 10.44 0.94
Mean 6.10 0.94 15.29 1.99
D90 16.72 1.67 20.37 3.78

Acetaminophen

Unprocessed

Processed

Number Distribution
(micrometers)
Volume Distribution
(micrometers)
Unprocessed Processed Unprocessed Processed
D10 0.74 0.60 8.9 2.2
Mean 5.0 1.7 22.3 4.8
D90 11.2 3.5 42.1 7.5