Product design expertise
Our product development teams are equipped to meet all your drug formulation development and product design expertise 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 our premier drug formulation services and expertise. Our data and experience-driven approach, including access to our proprietary technologies, ensures we address various problem statements effectively. We employ manufacturability and QbD principles in formulation design and strategy, ensuring no re-work is required for a scalable solution.
Experience with proven enabling technologies
Access our extensive experience in drug formulation development, utilizing 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
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By partnering with an integrated provider, there’s a convenience factor, a speed factor and a benefit in the regulatory environment. David Lyon, Senior Fellow Research, Lonza |