The Expanding Drug Design Space
New molecules emerging from discovery continue to deviate further from conventional drug-like properties. We are expanding the boundaries of the chemical drug space as we search for new and better compounds. Consequently, the percentage of poorly soluble drugs in the pipeline continue to grow. Since a drug’s solubility is critical for absorption within the digestive tract, this trend places tremendous pressure on formulation scientists. Since 2007, AustinPx has been developing the KinetiSol® Technology to address the need of improving bioavailability of poorly soluble drugs.
A fusion-based, solvent-free process that utilizes frictional and shear energies, KinetiSol rapidly transitions crystalline drug and polymer into an amorphous solid dispersion (ASD). KinetiSol has been applied to some of the most poorly soluble molecules, including deferasirox, abiraterone, tetrabenazine, and vemurafenib, and has proven to be a bioavailability enhancement solution at all levels of development.
KinetiSol’s unique and highly optimized equipment design offers many advantages over other amorphous dispersion technologies including:
- Broader Solution Platform: Applicable to a wider range of molecules including molecules with high melting points and poor solvent solubility, a broader formulation design space, and improved drug loading
- Lower development costs: Streamlined scale-up and significantly faster processing times
- Greener Technology: No solvents required, smaller physical and operational footprint
- Extended product life cycle: Possible IP creation through patented processing technology and composition of matter patents.
Formulation Development and Manufacturing with KinetiSol Technology
AustinPx offers comprehensive development, analytical testing and GMP manufacturing support for KinetiSol Technology enhanced APIs at all stages of development, including the handling of highly potent molecules. KinetiSol Technology has been developed at research and production scales to ensure speed to clinic and easy scale up to commercial production.
KinetiSol Technology formulations result in a substantial improvement in solubility compared to crystalline drug.
A Broader Amorphous Dispersion Technology
From the Idea to Market
An optimal technology for the entire lifecycle for creating amorphous dispersions
The KinetiSol Manufacturing Process
A streamlined processing technology at any scale
The KinetiSol technology can be run in batch or continuous operation mode and easily fits into a conventional oral manufacturing equipment train. Blended API and polymer/intragranular excipients are charged in 5 grams to 200 grams shots (up to 40kg/hour throughput) into the KinetiSol compounding equipment and rapidly (≤20 seconds) converted into an amorphous solid dispersion. This process is repeated until the desired batch size is produced. Processing is monitored in real-time, and upon reaching a specified heat profile (elevated temperatures are maintained for ≤5 seconds), the ASD material is ejected and quenched. The ASD is then milled and the resulting powder is ready for post-processing to create tablets or capsules.
AustinPx provides downstream oral finished dose development, manufacturing, and packaging of KinetiSol ASDs.
- Bottling and Clinical Labeling
GMP manufacturing is supported by our robust quality assurance system, project management team, quality control release, and stability storage and testing. Through engineering, infrastructure, operational systems, quality systems and training, AustinPx can also support the manufacturing of highly potent APIs.
Apply KinetiSol Technology to Your Next Problem Candidate
Rapid Feasability Studies with KinetiSol
Utilizing a rapid turnaround and cost-effective screening platform, the selection of polymers and/or excipients will be tailored to your API’s characteristics. In as little as 6 weeks, we can screen KinetiSol’s feasibility for your molecule and provide prototypes for animal PK testing.
For pharmaceutical companies looking to utilize the KinetiSol Technology in-house, AustinPx offers an equipment leasing program. Supported by our expert field services team, contracts include annual maintenance and formulation and processing guidance.
Watch the video below to learn more about KinetiSol.
We invite you to test the performance of your candidate using our proprietary KinetiSol Technology. Contact Us to Learn More about KinetiSol Technology.