KinetiSol®: Satisfying Unmet Needs
Poorly soluble drugs that have high melting points and don’t dissolve well in organic solvents are becoming commonplace. These drugs can’t be enhanced by spray drying or melt extrusion. They can be enhanced by KinetiSol®.
KinetiSol® supplements HME and spray drying in the other areas of this compound space when molecules are thermally labile or unstable in organic solution, for example. Additionally, KinetiSol® may be an alternative to spray drying when cost of goods or the availability of high volume manufacturing capacity is an issue.
KinetiSol® vs. Other Technologies
Technologies such as hot-melt extrusion and spray drying are established in the field and are often the first options tried with highly insoluble drugs. However, KinetiSol® possesses some key advantages over these technologies that can result in substantial benefits for drug product development and manufacturing.
- Non-solvent process
- No organic solubility requirement
- No safety/environmental issues
- No secondary drying
- Greater product bulk density
- Lower capital cost
- Lower operating cost
- Shorter residence times (seconds vs. minutes)
- Reduce thermal stress (lower temperatures for shorter durations)
- Greater mixing intensity
- Not viscosity limited
- Broader spectrum of polymers
- No plasticizers
- No torque issues
- Less process complexity
Versatility and Compatibility
KinetiSol® is compatible with all polymers commonly used in solubility enhancement applications. Additionally, KinetiSol® is able to process non-thermoplastic, high molecular weight, and highly viscous polymers without the need for plasticizers. This creates opportunities for unique compositions and correspondingly strong IP protection.
The table is only a partial list of excipient materials that can be incorporated into a KinetiSol® processed solid dispersion system. The KinetiSol® process is compatible with most all excipient materials used in oral drug delivery.