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SoluPath Flex™

SoluPath Flex™– The Customizable, Fixed-Price Solution toRapidly Improve Solubility

Low solubility is a common but complex hurdle on thepath to Phase I trials and commercialization. Through SoluPath Flex™,your project will be initiated and completed by a dedicated early developmentteam of experts. Our early development labs afford us the agility of a start-upwith the deep resources and expertise of a global pharmaceutical developmentleader.

AccelerateDevelopment with a Customized Solubility Enhancement Solution

Simplicity and Clarity – Build the Best Solution Knowing Exact Costsand Timelines:The simplicity begins with a menu of services, where fixed costs and timing arespelled out in black and white.

 Customizable – More Choices and More Efficiency: Select from a full array oftechnologies and services to tailor a unique solution that’s as unique as yourchallenges.

 Expert Advice – A Solution Built on Scientific Expertise: At the first meeting you’llwork directly with a solubility expert from Patheon to design a solution tomeet your unique requirements.

 Fast – Get responsive service and rapid results. In just one meeting you’llknow the approach, cost, timing and API requirements followed quickly byaquote.

 Only with SoluPath Flex™  can you plan,quote and launch a solubility enhancement solution custom tailored for yourmolecule, timeline and budget.

 SoluPath Flex™ Technologies

Drug Substance Characterization: Evaluate and understand the physical behaviorand characteristics of your API. Leverage physical data to drive productdevelopment needs.

 Solid Dispersions: Super saturated formulations that improve solubility, enhancingkinetic stability in a thermodynamically unfavorable state. Often this methodachieves bioavailability targets where other options fail.

 Microparticles: Micronization increases the surface area of particles to enhance thesurface area for dissolution. This is a quick, low-cost, low-risk method ofincreasing bioavailability for many low solubility APIs.

 Solubility Enhancement: Deploys an armory of solvents, co-solvents,surfactants, complexing agents, and crystallization inhibitors to improveabsorption and enable larger dose volumes.

 Lipid-Based Formulations: Improves absorption by using lipids, solventsand/or surfactants that solubilize, disperse and transport drugs across the gutwall.

 Prototypes: Evaluate stability and performance, scale-up your product.Leverage screening information to produce prototypes for stability testing and TOestablish manufacturing processes.

 Stability: Test chemical and physical stability of your lead formulation. Ensurethe chosen technique is suitable for in vivo studies.

 Manufacturing: Produce the lead drug product for PK or animal tox studies at the samefacility. Test your enhanced formulation versus non-enhanced formulations.

SoluPath Flex™ Approach

With SoluPath Flex™ you'll garner not justimpartial results, but have the advantage of Patheon's years of scientificexpertise to quickly and accurately determine a scalable delivery solution thatbest suits your compound's unique characteristics. To achieve that goal, you'llhave a cross-functional team of experienced scientists dedicated to yourproject's success.

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