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
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.
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 |
