Poorly Soluble Drugs
A Patented Technology
with Broad Applications
CritiTech’s Bioavailability Optimization Technology™ is a proven, proprietary drug micronization technology that enables a wide range of new and improved pharmaceuticals with multiple drug dosage and delivery options.
Who Does It Help?
The pharmaceutical industry is faced with ongoing solubility issues in its efforts to develop new and improved drugs to improve patient lives. 40% of drugs in development are never commercialized due to solubility problems.
CritiTech has spent over a decade developing its Bioavailability Optimization Technology™ to improve the solubility of poorly soluble drugs. It provides significant advantages versus other drug micronization technologies and can be used to:
- Enable development of a promising, but poorly soluble new chemical entity.
- Get a shelved drug back on the development track.
- Serve as a Life Cycle Management tool for drugs coming off patent.
- Repurpose an existing drug
- Facilitate a 505 (b)(2) pathway for expedited approval
CritiTech has successfully produced sub-micron particles across a variety of molecules, including peptides, with over a 90% success rate. The Bioavailability Optimization 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. As a result of working with dozens of drugs, CritiTech’s scientists have extensive experience and expertise in micronizing drugs.
Optimization Technology™ provides the following benefits:
- Ability to manipulate morphology
- Production of nanoparticles that are pure “naked” drug
- Ability to reduce particle size to <500 nanometers
- Produce nanoparticles with a narrow size distribution range
- No added excipients or co-milled materials
- Reproducible and commercially scalable