CritiTech’s Purcision technology is a patented and successful drug delivery platform that moves beyond conventional dissolution improvement theory that smaller is better. With Purcision, we focus keenly on optimizing specific surface area. 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 Purcision Particle Characteristics

• 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 drug micronization technologies without added excipients

Features of Purcision

• 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

Purcision Benefits

• 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 beyond that of other drug micronization technologies
• 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 Purcision Systems

	CritiTech RC612	CritiTech RC612B	CritiTech cFPC-411	CritiTech FPC-716
Supercritical fluid CO2	Batch	Batch	Continuous	Continuous
Approximate production scale	200 mg – 5 g	200 mg – 5 g	~75 g/hr	~1 g – 100s kgs
Proof of Concept/Development	✔	✔
cGMP Manufacturing			✔	✔
Non-Cytotoxic	✔	✔		✔
Cytotoxic	✔	✔	✔