Types of Collaboration with Partners
Poorly Soluble Partner NCEs
We routinely work with challenging partner drugs that have poor solubility or low bioavailability and need more enhancement than has been achieved with other technologies. We routinely work with high melting temp drugs, those with poor solvent solubility and drugs with degradation issues (oxidation, acid lability, etc.). We have been a successful last resort for drug development projects that would otherwise have been canceled.
Higher Drug Loading
We have had multiple successes in achieving higher drug loading than could be achieved via spray drying or melt extrusion. This is a function of polymers that we are uniquely able to process supporting higher drug loads than the polymers that can be processed in other technologies. If you need to achieve higher drug loading for your poorly soluble drug, try KinetiSol® before you give up.
Reformulating Approved Poorly Soluble Drugs
DisperSol has 3 products in development. All 3 are enhanced reformulations of approved drugs where we believe the current formulations have clinically meaningful drawbacks that may be resolved by our technology. We choose drugs that can not be commercially manufactured via other methods thus providing market exclusivity.
We have developed a lab-scale version of our equipment for earlier R&D. Feasibility studies can be done with as little as 10 grams of a NCE. The technology is the fastest throughput, directly scaleable method for making amorphous solid dispersions in a lab. The Research Formulator grew directly out of our need for a smaller-scale version of our process that would be better suited for earlier development work.
The Process of Partnering with DisperSol
Step 1: Compound Questionnaire
After signing a CDA, we send a compound questionnaire to learn more about the physical and chemical properties of your drug. Our goal is to make an initial assessment for suitability for KinetiSol® processing and to make sure that you have explored other options that might work for your drug. We look to engage on a project only if we feel that we are uniquely enabling.
Step 2: Compound Assessment Study
Once both we and our partner wish to proceed, we start with a limited set of formulation iterations (usually 10) focusing on one or two polymers that based on our experience we think likely to be helpful. For a tough drug, this short a study won’t solve all the issues. It is designed as a “fail early” study so that we can assess how the drug fares in KinetiSol® processing and the odds that the project will succeed. At the end of the study, we give a final report, our judgement on the success odds and if we recommend proceeding, an estimate for the next phase of work.
Step 3: Formulation Feasibility Project
In this phase, the goal is to develop one or more prototype KinetiSol® formulations which meet the partners success criteria, have good stability and demonstrated manufacturability on our batch manufacturing compounder. We supply formulation samples for partner lab and animal testing.
Step 4: Clinical Testing of Lead Formulations
A successful formulation feasibility project flows straight into proving the formulation performs as desired in humans. DisperSol has a GMP pilot plant from which it can support clinical trial material needs for phase I and II studies.
Step 5: Commercial Manufacturing of KinetiSol® Formulations
While DisperSol can support low-volume commercial products, it is recommended that for phase III studies, registration batches and commercial supply, we tech transfer our manufacturing compounder(s) and technology to a mutually agreeable commercial manufacturing site. Our compounding operation has a small footprint and fits in-line with most any tableting line.
Our Business Model
KinetiSol® is a patent-protected process that requires our proprietary equipment.
We do not “sell” our equipment. Our technology can be accessed via a licensing contract for use of our intellectual property in making your product.
Licensing deal structures typically consist of a royalty on product sales and developmental & commercial milestone payments.