Formulations are developed based on extensive API characterization and pre-formulation assessments inclusive of robust problem statement analysis. Our science and engineering core strengths have enabled the development of technology selection methodologies and specialized lab-scale equipment that can accelerate proof of concept and early formulation studies while minimizing API requirements. 

Our product development teams are equipped to meet all of your formulation and product development needs in a phase-appropriate manner, including:

  • API characterization and problem statement definition
  • Technology selection for best formulation options
  • Addressing bioavailability or dissolution rate issues
  • Profiling and modulating pharmacokinetics
  • Developing a formulation strategy and requirements
  • Developing and manufacturing phase-appropriate clinical material 
  • Developing and validating processing and analytical methods
  • Regulatory preparation services including generating and documenting all required data for clinical trial filings.
Technology selection is based on models, reference maps of critical parameters, and an extensive database developed from the study and advancement of thousands of molecules.

View The Webinar

An Integrated Approach to Rapidly Delivering Bioavailability-Challenged Small Molecules to the Clinic

Formulation development & product development expertise

We have broad capabilities across the full range of formulation problem statements but with premier expertise in:

  • bioavailability, solubility and dissolution rate issues that plague the majority of new chemical entities;
  • modulation of pharmacokinetics using specialized targeted and modified release technologies to meet the needs of increasingly specific target product profiles; and
  • low dosing / HPAPI processing and formulations for oncology and other indications. 

A data and experience-driven approach is utilized in selecting from a full range of enabling technologies to address these and other problem statements.  Proprietary technologies and processing have been developed to optimize formulation performance and provide for accelerated development timelines. Ultimate manufacturability and QbD principle are built into formulation design and formulation strategy to ensure no later stage re-work is required to ensure scalable solutions.

oral drug products and intermediates

formulation and product development centers of excellence

Bend, OR, USA

Production, Sales & Support, Research & Development

1201 NW Wall St.
Bend, OR 97703
United States of America

Tampa, FL, USA

Production, Sales & Support

4910 Savarese Circle
Tampa, FL 33634
United States of America

related content

Formulation and Development for Amorphous Solid Dispersion
Webinar on-demand
Manufacturing Amorphous Solid Dispersions by Spray-Drying: Scale-Up Approaches
Webinar on-demand
Solid Form Services
Tech brief
Technology Selection for Oral Bioavailability Enhancement Programs