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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 thousands of products. In fact, Patheon has helped customers receive more NDA approvals than any other CMO.*

Patheon leverages the speed and agility of a non-GMP environment for the rapid screening of potential formulations, and gives you royalty-free access to a comprehensive range of dose forms:

Immediate Release

  • Bilayer tablets
  • Trilayer tablets
  • Microtablets
  • Beads in capsules
  • Coated beads
  • Tablets in capsules
  • Fast dispersible tablets
  • Liquid-filled capsules
  • Biphasic liquid-filled capsules
  • Bilayer chewable tablets
  • Beads in liquid-filled capsules
  • Sublingual tablets

Controlled Release

  • Bilayer tablets
  • Trilayer tablets
  • Microtablets
  • Beads in capsules
  • Coated beads
  • Tablets in capsules
  • Laser-drilled CR tablets
  • Liquid-filled capsules
  • Biphasic liquid-filled capsules
  • Beads in liquid-filled capsules
  • Hydrophilic gel matrix
  • Polymer matrix
  • Wax matrix
  • Pulsatile release
  • Polymer coating

Sterile

  • Small and large volume parenterals
  • Lyophilization

Our early development strength extends to the full range of pre-formulation analytic technologies. Patheon can structure a highly efficient, fully integrated early development program that can accelerate your project to First Time In Man studies and beyond. These programs include excipient compatibility studies, process and analytical method development, pilot-scale manufacturing, and can easily dovetail into late development and commercial supply. This approach reduces the risk of costly reformulation at later stages and facilitates streamlined tech transfer. What's more, our unique Quick to Clinic™ service guarantees fast delivery of Phase I Clinical Trial Materials when solubility is not an issue. And if solubility is an issue, there's SoluPath™, the first fixed-price, multi-platform solution to improve bioavailability.

Our scientists approach each formulation project with the commercial product in mind. Whether your goal is to out license or follow through to commercialization, Patheon will help you to quickly develop a formulation that achieves manufacturability and maximizes value.

*Source: PharmSource® - Market Intelligence Briefing, pg.6, February 28, 2012.

Case Study: Formulation Development for Complex APIs and Dose Forms

The Challenge A large pharmaceutical company contracted Patheon to develop a bilayer tablet, each layer consisting of a different drug substance and release profile. One of the drugs was low dose and moisture sensitive. There were also layer lamination issues during formulation development and in storage.

The Solution A non-aqueous granulation process was developed to achieve good content uniformity and prevent loss of potency of the moisture sensitive active ingredient during manufacture. A statistical design of experiments (DoE) program consisting of a pilot screening and a full-factorial design study was performed to construct the subsequent statistical design.

The Outcome Patheon produced an effective design-space for the process, process validation, and product storage conditions.

Ask The Experts

Anil Kane, Ph.D., MBA

Anil Kane, Ph.D., MBA
Dr. Kane has more than 25 years of experience in the science and business of taking molecules throug
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Joseph A. Fix, MBA, Ph.D.

Joseph A. Fix, MBA, Ph.D.
With 30 years of experience converting discoveries into businesses, Dr. Fix holds 24 patents, includ
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John S. Kent, Ph.D.

John S. Kent, Ph.D.
With over 35 years of experience, Dr. Kent offers expertise in overcoming development challenges for
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K. George Mooney, Ph.D.

K. George Mooney, Ph.D.
Dr. Mooney has 35 years’ experience in pharmaceutical sciences and exploratory drug development. He
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Larry Gatlin, Ph.D.

Larry Gatlin, Ph.D.
Dr. Gatlin is an industry veteran with more than 36 years of scientific and leadership experience. H
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Lynn Van Campen, Ph.D.

Lynn Van Campen, Ph.D.
With more than 30 years of drug development experience, Dr. Van Campen is an expert in the establish
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Mark A. Staples, Ph.D.

Mark A. Staples, Ph.D.
Having worked 32 years with all early to mid-stage companies, Dr. Staples is an expert at the early
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Rodney Pearlman, PhD.

Rodney Pearlman, PhD.
An expert in the development of scientific and business strategies for start-ups, Dr. Pearlman bring
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Roman Hlodan, Ph.D.

Roman Hlodan, Ph.D.
Dr. Hlodan is an expert in the development of biopharmaceuticals, including analytical method devel
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Leah Appel, Ph.D.

Leah Appel, Ph.D.
Dr. Appel has over 20 years’ experience in the pharmaceutical industry developing drug delivery tech
Read More »

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