One Price, Multiple Technologies – Fast Results
Low solubility is a common but complex hurdle on the path to Phase I trials and commercialization. SoluPath™ is the first fixed-price, multi-platform solution to improve bioavailability.
The SoluPath™ Package
- $90,000 fixed-price, all-in-one formulation package of multiple leading-edge technologies to control early development costs
- Accelerated development with parallel formulation screening increases speed to First in Man trials as well as your chance of success
- All technologies in-house, Patheon is not vested in any particular technology, just your success
- Scientific expertise to deliver the advantage of a scalable formulation
By giving you access to multiple leading-edge technologies at the same time, SoluPath™ is the faster, more affordable alternative to having your compounds screened by a succession of separate vendors who are limited to their proprietary technology.
Solid Dispersions Supersaturated formulations that improve solubility, enhancing kinetic stability in a thermodynamically unfavorable state. Often this method achieves bioavailability targets where other options fail.
Microparticles Micronization increases the surface area of particles to enhance the surface area for dissolution. This is a quick, low-cost, low-risk method of increasing bioavailability for many low solubility APIs.
Solubility Enhancement Deploys an armory of solvents, co-solvents, surfactants, complexing agents, and crystallization inhibitors to improve absorption and enable larger dose volumes.
Lipid-Based Formulations Improves absorption by using lipids, solvents and/or surfactants that solubilize, disperse and transport drugs across the gut wall.
The SoluPath™ Approach
- Basic analytical method development for potency and dissolution assays
- Expert assessment of available/existing data
- The five most promising technologies will be selected based on analysis
- Three sample formulations from each technology for up to 15 test screens
- Narrowed down to four lead formulations across a variety of technologies
- Assessment of XRD and DSC data
- Preparation of reference formulation for PK
- Potency testing on 4 lead formulations and reference formulation
- Potency of lead formulations retested after PK study
- Final report, including PK result interpretation and recommendation for First in Man trials
With SoluPath™ you'll garner not just impartial results, but have the advantage of Patheon's years of scientific expertise to quickly and accurately determine a scalable delivery solution that best suits your compound's unique characteristics. To achieve that goal, you'll have a cross-functional team of experienced scientists dedicated to your project's success.
Case Study: SoluPath™ Improves Bioavailability by 4x in Just Three Months
The Challenge One of the biggest challenges faced by pharmaceutical scientists is poor solubility and bioavailability of new molecular entities (NMEs). A small biotech company was developing a compound with poor solubility and bioavailability, and needed help determining the best formulation to overcome these issues.
The Solution We started with an upfront assessment of the solid-state and biopharmaceutical properties of the drug substance. The results were used to guide prototype formulations. Then employing the parallel screening approach of Solupath™, several technologies were evaluated, including solid dispersion (by spray drying), particle size reduction methods (by high energy wet milling to produce reduced particle size suspensions), and lipid-based delivery systems.
The Outcome Based on the data, the bioavailability of the compound was increased by more than four times. In just three months, the compound was able to progress from preformulation to clinical formulation development with significantly improved chances for success in First in Man trials.