Benefits of CritiTech's Supercritical Precipitation
- Ambient processing temperatures
- Unique particles ranging from 250 nanometers to 10 microns
- Narrow particle distribution range
- Exponential increase in surface area and dissolution rate
- API alone or with excipients
- Amorphous, crystalline or co-crystalline materials
- Low moisture content
- Virtually eliminates residual solvents
CritiTech’s nanoparticulate drug development and manufacturing process provides the ability to micronize a wide variety of small-molecule and biotechnology drugs using its proprietary Supercritical Precipitation Technology. The technology consistently produces particles with a mean particle size in the range of 500 nanometers to 5 microns and a narrow distribution around that mean. The technology also includes a method to harvest these particles on a continuous basis. As a result of working with dozens of drugs, CritiTech’s scientists have deep experience and expertise micronizing drugs. Supercritical Precipitation is an advanced and innovative approach to the production of nanoparticulate pharmaceuticals. The patented processing and compound-harvesting technologies that underpin CritiTech’s drug micronization capabilities are efficient, safe, and friendly to the environment.
Improving the likelihood of Development Success for New Compounds and Novel Agents
Water Solubility Problem
It is estimated that 70% – 90% of all new chemical entities have water-solubility problems that make these compounds unusable as drugs. To address this problem, companies often employ complex strategies to increase water solubility, such as using excipients, co-solvents (alcohol or detergents), prodrug formulations, or combining drugs with a carrier molecule. However, in many cases a reduction in particle size may be the appropriate means. The appeal of improving aqueous solubility via reduction of the size of the drug particle lies in its simplicity. Particle size reduction results in increasing the effective surface area of the compound, thus enhancing its dissolution rate. However, most micronization technologies are unable to reduce particle size to less than 1 micron and include a number of other issues as well. CritiTech’s Supercritical Precipitation Technology overcomes many of the limitations of other drug micronization techniques.
Opportunities to Enhance the Value of Currently Marketed Drugs
A growing number of pharmaceutical companies are now applying the technologies of drug-development/delivery companies to enhance the convenience, safety, and efficacy of currently marketed products. When successful, the approach of adding value to established products can yield substantial commercial success.
Supercritical Precipitation Technology is an Effective Life Cycle Management Strategy for Existing Drugs
There are hundreds of case studies showing that revenues from a drug can decrease by 70% upon patent expiration. Application of CritiTech’s Supercritical Precipitation Technology to existing compounds can potentially create a reformulated and improved 2nd generation drug that would be elgible for an extended period of exclusivity. CritiTech can help enable pharmaceutical companies to cost-effectively introduce a 2nd generation product with improved patient benefits due to the following:
- Improved pharmacokinetics
- Increased efficacy
- Reduced adverse effects
- Improved dosing regimen
- New routes of administration
CritiTech’s Supercritical Precipitation Technology should be in your “toolbox” of options to improve pharmacokinetics of challenging drugs that you are working with.
Manufacturing Advantages of CritiTech's Supercritical Precipitation Technology
CritiTech’s Supercritical Precipitation Technology provides the following benefits in the manufacturing process:
- Particle formation occurs in a much shorter time – minutes/hours as opposed to days/weeks.
- Produces a much narrower range of particle sizes than milling
- Continuous processing
- Milling processes induce electrostatic charge on the particles, which necessitates coating of the resulting particles to prevent re-agglomeration. CritiTech’s Supercritical Precipitation Technology does not induce such electrostatic charges onto particles.
- Processing does not require removal of the milling agent.
- Processing is safely conducted in closed systems with complete recovery of solvents and CO2 for reuse or safe disposal.
- Scalable and reproducible.
A final advantage of CritiTech’s Supercritical Precipitation Technology is in the environmentally friendly nature of the processes. Organic solvents traditionally used in the industry may be hazardous to the environment or toxic to humans and animals. Because of the closed loop nature of CritiTech’s micronization process, the release of harmful substances to the atmosphere is substantially reduced, if not totally eliminated.
Case Study Results