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Patheon

Small Molecule Product Development

Preformulation Screening

With speed and efficiency, evaluate the physical and chemical properties of your drug substance for a clear view of the path to Phase I clinical studies and beyond. Patheon gives you access the full breadth of advanced analytical technologies and preformulation services.

  • Chemical purity analysis
  • Physicochemical properties
  • Solid form definition and analysis
  • Molecular structure analysis
  • Excipient compatibility testing
  • Amorphous vs. crystalline solid state testing
  • Aqueous and solvent solubility
  • Solution and solid state stability
  • Vehicle screening for ADME and toxicity

Working with Patheon at this early phase opens the door to a partnership that can take you all the way to and through commercialization. Fully integrated services that deliver speed, flexibility and a streamlined supply chain. One partner, one team, one seamless solution customized to your exact needs.


Formulation Development

Take your discoveries to the proof of concept milestone with speed and efficiency while laying a firm foundation for commercial success. Patheon has helped clients receive more new drug approvals (NDAs) than any other CMO.* By offering the full range of analytical, formulation and dosage form technologies and solutions, we can tailor a lean, fully integrated drug formulation program precisely suited to your molecule and business. One that will accelerate your project to first-in-human studies and beyond.

You will also have access to the speed and agility of a non-GMP environment, and unique solutions you won’t find anywhere else. Patheon Quadrant2 ™ employs computer modeling and fundamental science to improve bioavailability. Patheon Quick to Clinic™ delivers high-quality Phase I clinical supplies in as little as 12 weeks. Nobody gets you to clinical trials faster than Patheon. And nobody gives you access to more early-phase dosage formulation choices with a program more closely tailored to your needs.

  • Blend in capsules
  • API in bottles
  • API in capsules
  • Blend in bottles
  • Lyophilized vials
  • Sterile liquid in vials
  • Softgels

*Source: PharmSource ® Trend Report, March, 2016.

Solubility Enhancement

Considering that 90% of drug candidates have bioavailability issues, making sure your program is prepared for all phases of clinical trials from the very start is the fast way forward. Patheon Solubility Enhancement Services approaches BCS II and IV drug substance solubility issues a fundamentally different way that identifies the solubility enhancement technologies most likely to work before you get started. That helps eliminate rework and worry later on.

Try the Patheon Solubility Solution Finder and then talk to a Patheon solubility expert to see how we can help meet the needs of your molecule, timeline and budget with a custom-tailored complete solution. Even if it means another company handles your solubility enhancement process.

With Patheon Solubility Enhancement Services, you get a partner you can trust with the skills your discovery deserves: Comprehensive analytical services. Preformulation characterization and technology screening. Formulation design and process development built upon computer modeling and Quality by Design principles. Proven cGMP clinical-scale manufacturing. And an array of solubility technologies that includes proven solutions not available anywhere else.

Analytical Services

Achieve repeatable high quality and robust process design at every phase of your small molecule pharmaceutical development projects – preformulation screening to clinical batch release testing – with access to a comprehensive array of analytical services.

  • Physical and chemical definition and analysis
  • Analytical method development and validation
  • Process development and validation
  • Cleaning method validation and verification
  • In-process production support
  • Dissolution testing
  • Impurity tracking
  • Stability testing for various ICH climatic zones
  • PAR studies

We have cGMP labs staffed by highly experienced teams within each development site. You’ll have access to a comprehensive, state-of-the-art stability testing facility featuring the latest automated systems and DEA-compliant areas for controlled substances.

Gain the scientifically sound data you need for regulatory submissions and to guide your next steps. When those next steps include Patheon, we can reuse data gathered in development to bring significant speed and efficiency to the commercialization of your product. Get high-quality analytical data for high-quality products, processes and business decisions.


Manufacturing Process Development

Build quality and robust repeatability into your manufacturing process. Do it during early phases to accelerate through later phases and into commercial production. Because our capabilities span the full breadth and depth of the pharmaceutical development life cycle, because we have the experience of thousands of projects, we know what your process needs to succeed today and tomorrow. With Patheon you’ll get a process that is reliable, efficient and built to deliver repeatable quality when you bring your product to market.


Dosage Forms

Every molecule offers unique technical challenges, just as every client has specific business requirements. The more options that are available, the more precisely you will be able to meet these needs. This is why we offer such an expansive range of choices in dosage forms and technologies.


Oral Solids

Bring more than 40 years of experience to your project. Access a remarkable range of conventional and specialized oral solid dosage form options. Further expand your options with innovative combinations of these forms and a variety of controlled-release technologies. All these choices are executed with the expansive scientific resources and expertise to rapidly develop successful formulations for even the most complex APIs including highly potent compounds and controlled substances.


Conventional

  • Immediate-release tablets
  • Powder-filled capsules
  • Powders, granules & coated beads


Specialized

  • Liquid-filled capsules
  • Controlled-release tablets
  • Multilayer tablets
  • Fast-dispersible tablets

Softgels

Attractive and easy to swallow, most patients prefer softgels. Access a broad palette of shapes, sizes and colors, as well as unique chewable, topical and suppository options. Leverage specialized technologies to meet the needs of your market and molecule, including advanced solutions for enhancing solubility and bioavailability.

  • Softgel Capsules
  • Twist-Off Softgels
  • EnteriCare® Softgels
  • LiquiSoft Softgels
  • Versatrol Softgels
  • Solvatrol Softgels
  • Soflet® Gelcaps
  • Chewels® Chewable Gels

Softgels are easily scaled for every phase of development and beyond. That’s because all batch sizes are made the same way and on the same equipment. Patheon provides you with the expertise to make the most of all of the many advantages of softgels:

  • Specialized technologies to enhance solubility
  • Precise control of drug release rate and site of absorption
  • Lower dose levels with higher bioavailability
  • Faster drug action and reduced food effect
  • Hermetic seal for oxygen-sensitive APIs
  • Masking of unpleasant tastes and odors
  • Opacity range from clear to opaque for light-sensitive APIs
  • Liquid, suspension, semi-solid and solid fill materials of any viscosity
  • Alkali or acidic gelatin shells formulated for each fill material
  • Reduced risk exposure with highly potent compounds
  • Wide selection of shapes, sizes and colors
  • Options for chewable and topical applications

Steriles

Access extensive sterile pharmaceutical manufacturing capabilities at any scale, including terminal sterilization, aseptic processes and world-class expertise in lyophilization. With Patheon you’ll also have access to a state-of-the-art commercial-scale cGMP manufacturing suite for prefilled syringes and cartridges.

  • Liquid Small Volume Parenterals (SVP): Choose from a wide range of vial forms and sizes to achieve exactly the right solution for your project.
  • Liquid Large Volume Parenterals (LVP): Available in a broad array of sizes, we often utilize this dose form to help clients efficiently achieve proof of concept.
  • Lyophilized Vials: Benefit from the speed and efficiency of having access to seamless scale-up from development to commercial manufacturing. This is possible because the equipment capabilities in our North American and European facilities range from 2 mm vials to 100 mm vials. This enables precise control of your process conditions at any phase or scale.
  • Prefilled Syringes & Cartridges: Ready-to-use dosage formats that enable self administration of parenterals which once required a clinical visit. So as the healthcare industry seeks to move treatments into the home Patheon is investing in capabilities that will keep you ahead in the evolving marketplace.

Our sterile capabilities also include process development and manufacture of biologic drug substances at all scales from clinical to global commercial. With Patheon as your single-source partner, you’ll be able to bring your large molecule discoveries to market with more speed and efficiency than ever before.


Unique Solutions

The “right solution” is the one that most directly addresses the specific needs of your molecule, timeline and budget. This is true of everything we do, and vividly demonstrated by our unique solutions. These highly customizable pharmaceutical development offerings bring together core capabilities and advanced technologies to overcome your most critical challenges – solubility, bioavailability and accelerated proof of concept – with maximum speed, efficiency, quality and value in ways only possible with Patheon.

  • Patheon Quadrant2
  • Patheon Quick to Clinic

Patheon Quick to Clinic – High-quality Phase I clinical trial materials in as little as 12 weeks.

Only twelve weeks from receipt of your API, Patheon Quick to Clinic™ can deliver bulk clinical trial materials for first-in-human studies. That includes a one-month stability study so you have all the data you need to make informed proof of concept decisions and complete regulatory submissions.

Right First Time/On-Time delivery performance at Patheon is second to none, as is our regulatory track record. In fact, we’re the leading CDMO in the world for quality. Patheon Quick to Clinic delivers maximum speed without compromising quality. What’s more, this accelerated program gives you access to five flexible dosage forms.

  • Blend in capsule
  • API in bottle
  • API in capsule
  • Blend in bottle
  • Softgel

Nobody can get you to Phase I clinical trials faster with more dosage form choices, higher quality and a drug product with more built-in value.


Patheon Quadrant2 – Bioavailability enhancement design technology.

Computer-assisted formulation design platform for bioavailability enhancement. Following Quality Target Product Profile (QTPP) guidelines, it enables faster, broader and more rigorous formulation design and development. The scientifically disciplined approach of Patheon Quadrant2™ pays off at every stage of the product life cycle. Additional complimentary technologies include a free drug assay, phase diagrams, physical stability mapping and analytical development. The  Patheon Solubility Solution Finder exemplifies how a QTPP can provide technology recommendations.

Do you want to learn more?

We look forward to learning about your specific needs, please contact us.

PHONE
+1.919.226.3200
PHONE
+1.866.Patheon