Product design expertise
Our product development teams are equipped to meet all 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
Formulation expertise
We have broad capabilities across the full range of formulation problem statements with premier expertise in:
- Bioavailability, solubility and dissolution rate issues
- Modulation of pharmacokinetics using specialized targeted and modified release technologies to meet the needs of your TPP
- Low dosing / HPAPI processing and formulations
Benefit from access to our data and experience-driven approach, selecting from a full range of enabling technologies to address the above and other problem statements. Proprietary technologies and processing have been developed to optimize formulation performance. Manufacturability and QbD principles are built into formulation design and strategy to ensure no re-work is required for a scalable solution.
Benefit from access to our extensive experience with a range of proven enabling technologies, many of which have been developed or advanced by our teams:
- Solid dispersions
- Multiparticulates
- Particle size reduction
- Fixed-dose combinations
- Engineered particles for inhaled applications
- Modified- and targeted-release formulations
- Sterile fill and finish for parenteral applications
David Lyon, Senior Fellow Research, Lonza