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Formulation Development

Formulation development is a core offering throughout Patheon's global network. We have deep experience creating effective formulations for a countless variety of molecules. In fact, Patheon has helped customers receive more NDA approvals than any other CMO.*

Early-Phase Formulation Development

When taking a discovery to the proof of concept milestone, speed and efficiency are critical. However, the key is to make sure that efficiency is the result of very well-chosen steps that also take you closer to your ultimate goal of commercial success.

With Patheon you will be able to leverage the experience of thousands of projects, as well as the full range of analytical, formulation and dosage form technologies and solutions. You will also have access to the speed and agility of a non-GMP environment. By offering so many options, Patheon is able custom-tailor a lean, fully integrated early development program precisely suited to the specific needs of your molecule and business. One that will accelerate your project to First In Human studies and beyond.

Your formulation will be guided by our expertise in preformulation screening. If solubility is an issue, there's SoluPath Flex ™, the customizable, fixed-priced solution to rapidly improve solubility. If solubility is not an issue, our unique Quick to Clinic™ program offers high-quality Phase I clinical supplies in as little as 12-weeks, including 30-day stability testing. Nobody gets you to clinical trials faster, PLUS nobody gives you more early-phase-appropriate dosage formulation choices:

  • Blend in Capsules
  • API in Bottles
  • API in Capsules
  • Blend in Bottles
  • Oral Liquids
  • Softgels
*Source: PharmSource® - Market Intelligence Briefing, pg.6, February 28, 2012.

Process Development

By building quality and manufacturability into your process during early phases, Patheon can help you to quickly advance through later phases and into production upon regulatory approval. Because our offerings span the full breadth and depth of the pharmaceutical development life cycle, and because we have the experience of thousands of projects and molecules, we know what works at every stage. What's more, we are experts in making Quality by Design integral to process development.

Set the Stage for Future Success

As early in your project as possible, Patheon's goal will be to solidify a process that sets you up for commercial success. A process that can be readily scaled up from small batch to commercial supply with minimal risk of costly delays. A process that is economical, efficient and built to deliver repeatable quality when you bring your product to market.

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