Pre & Early Formulation Development
From API insight to early-phase formulation confidence.
GMP
LABORATORIES
20+ YEARS
ANALYTICAL EXPERTISE
TWO
UK SITES
Could formulation gaps be creating risk downstream?
Do you have clear API developability data to guide early formulation and excipient selection? Is your CDMO transfer package ready for handover? For many programmes, the answer to one or both of those questions is no, and the cost of finding out late is significant.
Resolian delivers integrated pre- and early-development solid formulation support, combining analytical and materials science expertise with small-scale practical capability.
We help you identify and resolve formulation risks early, so your programme moves forward on schedule and with confidence.
Why Early Formulation Decisions Matter
Early-stage formulation choices have a lasting impact on your programme.
Without the right data, issues such as poor API stability, excipient incompatibility, or poor powder processability can surface late in development, where they are costly and slow to fix.
Early insight enables smarter decisions around:
API suitability and developability
Excipient selection and compatibility
Manufacturability and scalability
Stability and performance risks
The right data, gathered early, protects your timeline and your investment.
Our Integrated Capability
We guide your molecule from initial characterisation through to prototype formulation and CDMO-ready data packages,
across four integrated service areas.
API Characterisation & Developability
Build a comprehensive understanding of your API’s physical and chemical behaviour before formulation decisions are made.
- Solid form and polymorphism analysis
- Thermal behaviour and transitions
- Hygroscopicity and moisture sensitivity
- Solubility, pKa, and partition coefficient
- Particle size, morphology, and surface properties
- Stability, degradation pathways, and impurity profiling
These studies provide the critical developability insight needed to guide formulation strategy and reduce downstream risk.
Excipient Compatibility & Stability Studies
Identify and mitigate risks from API-excipient interactions before they affect your programme.
- Small-scale stressed blends
- Exposure to heat, humidity, and light
- Stability-indicating LC and LC-MS analysis
- Solid-state monitoring (PXRD, DSC)
- Moisture analysis (DVS, Karl Fischer)
- Spectroscopic interaction screening (FTIR)
Early identification of incompatibilities enables data-driven excipient selection and a more robust formulation strategy.
Materials & Powder Behaviour
Understanding how your materials behave during processing is essential for consistent, scalable manufacture.
In conjunction with full physical characterisation, we evaluate:
- Flow properties (rheometry, shear cell testing)
- Segregation risk and content uniformity
- Wettability and surface energetics
- Packing and density behaviour
These insights ensure your formulation is robust, consistent, and ready for scale-up.
Formulation & Prototype Development
Generate early formulations using minimal material while capturing the performance data your programme needs.
- Blend preparation and optimisation
- Lubricant and binder screening
- Particle size optimisation and de-agglomeration
- Direct compression tablet prototyping
- Tabletability and compressibility profiling
Performance testing includes hardness, friability, uniformity, disintegration, dissolution, stability, and sorption profiles.
All work is designed to generate CDMO-ready data packages, enabling seamless technology transfer to your manufacturing partner.
Underpinned by Integrated Analytical Support
Every formulation project at Resolian is supported by in-house analytical capability delivered within GMP laboratory environments, ensuring data integrity and regulatory readiness throughout.
Techniques include stability-indicating HPLC/UPLC, impurity profiling (LC-MS, GC-MS), elemental analysis (ICP-MS/OES), solid-state confirmation (PXRD, DSC, TGA), and particle size and morphology analysis.
Seen enough? Let’s talk.
Speak to our formulation team about your programme.
Why Clients Choose Resolian
Small-scale flexibility with GMP-level confidence
Materials science embedded into every formulation decision
Seamless analytics across two UK sites
Clear, phase-appropriate recommendations at every stage
Your Goals. Our Science.
Ready to de-risk your formulation programme?
Our team can support you at any stage, from initial API characterisation through to a CDMO-ready data package.
