PROBLEM · SOLUTION · EVIDENCE · ACCESS
NEXT GENERATION AMORPHOUS DISPERSION TECHNOLOGY
Solvent-free amorphous solid dispersions, from feasibility to commercial supply.
WHY NOW
THE NEXT WAVE OF GENERICS IS AMORPHOUS
High-value amorphous solid dispersion (ASD) products are approaching loss of exclusivity.
48
ASD products approved by the US FDA between 2012 and 2023
54%
Made by spray drying; 35% by hot-melt extrusion
2026+
Compound patents and exclusivities expires on the products below
Sample set of ASD products coming off patent
| Xtandi® | enzalutamide | Spray drying | EU (DE) SPC June 2028; US 2027 | |
| Erleada® | apalutamide | Spray drying | US 2030 (extension pending to 2032) | |
| Tukysa® | tucatinib | Spray drying | US 2025 to 2031; EU 2032 | |
| Epclusa® | sofosbuvir / velpatasvir | Spray drying | US 2028 to 2034 | |
| Zelboraf® | vemurafenib | Solvent / anti-solvent | US 2026 to 2030 |
Compound patent, SPC or exclusivity milestones, not launch dates; national positions and litigation may differ. Sources: Int J Pharm X 2024; JUVE Patent; AstraZeneca and Johnson & Johnson disclosures 2024; Pharsight; GreyB 2026.
ASD’s Represent at $50B* Market
Estimated peak annual sales of commercial ASDs.
Growing Percent of Small Molecule Pipeline
An estimated 80% of new chemical entities in the pipeline are poorly soluble.
Molecules are increasingly more complex
Molecules are increasingly demonstrating higher melting points, heat sensitivity, poor solubility requiring more advanced manufacturing technologies.
* Source: IQVIA
WHY NOW
THE SPRAY DRYING PROBLEM
The ASD manufacturing process chosen today sets CAPEX investments, operational costs, supply chain complexity, and scale up and down risk for the life of the product.
Complexity Results in Supply Chain Complexity and Production Risk
Spray drying requires extensive infrastructure
Solvent plant, nitrogen generation, VOC abatement or scrubber systems require extensive footprints and operational infrastructures.
Scale-up and -down changes the product
As market demands change, scale up and down events require additional development work and studies as scale changes between spray dryers can alter particle properties and manufacturing performance.
THE TECHNOLOGY
AMORPHOUS DISPERSIONS WITHOUT SOLVENT
KinetiSol™ uses frictional and shear energy to fuse drug and carrier into an amorphous solid dispersion in under 20 seconds. No solvent. No drying step.
KinetiSol Compounder
Research & development scale. Preclinical to Phase I/II. Fits a standard laboratory.
KinetiSol Compounder
Phase II to commercial. Up to about 20 kg/h. Fits a standard GMP suite.
Six advantages, one result
ECONOMICS CASE STUDY
WHERE THE COST DIFFERENCE COMES FROM
Solvent-free is cheaper, not just simpler. In one commercial-scale ASD product modelled by AustinPx, over 85% of a spray-dryer feed is solvent; KinetiSol turns essentially more input into actual product.
Unit operations
Tablet ASD content: ~50% (spray drying) vs ~75% (KinetiSol).
Modelled result at commercial scale (U.S. dollars)
$20M
Annual cost of goods, spray drying
$12M
Annual cost of goods, KinetiSol
30-40%
Lower cost of goods for KinetiSol
HOW TO ACCESS KINETISOL
ONE TECHNOLOGY. MULTIPLE PATHWAYS.
Solvent-free is cheaper, not just simpler. In one commercial-scale ASD product modelled by AustinPx, over 85% of a spray-dryer feed is solvent; KinetiSol turns essentially more input into actual product.
Illustrative timeline for KinetiSol from feasability through commercial
Development
With AustinPx
Feasibility, formulation and process development, analytical and GMP clinical manufacturing in Georgetown, Texas.
KinetiLease™: in your own laboratory
A KinetiSol Formulator leased for your development lab. Installation, training and support included. Non-GMP use.
Contact Us
We invite you to test the performance of your candidate using our proprietary KinetiSol Technology. Contact Us to Learn More about KinetiSol Technology.