Services
Services
Every service we offer connects back to the three foundations of drug development: stability, manufacturability, and bioavailability. These aren’t isolated challenges, instead the decisions you make in one area will shape the outcomes you achieve in others.
That’s why our integrated approach spans disciplines ranging from API crystallisation through to drug product formulation, and considers the entire development lifecycle, from early pre-clinical decisions through to filing. The support we provide is always stage-appropriate: the right level of insight for where your programme is now, guided by our experience of what comes next.
Whether you need a single focused piece of work or a more expansive package spanning multiple disciplines, we tailor our involvement accordingly, keeping the full picture in view and helping you move forward with confidence.
Comprehensive solid form screening to reduce development risk and maximise your opportunities for success.
Selecting the solid form is a key development milestone and helps shape everything that follows, from how well the material will formulate, to how easy the formulation will be to manufacture, and what its shelf life will be. It also introduces opportunities for new IP with the potential to add value to an asset and extend exclusivity.
We carry out systematic, risk-aware screening and characterisation of all viable solid forms, and help you identify and progress the right one for your programme.
Where a complex or metastable form is unavoidable, we help you understand it and manage it with confidence through every development stage.
Capabilities
Solubility screening
Salt, co-crystal, hydrate and solvate screening
Polymorph screening and relative stability assessment
PXRD (including controlled temperature and humidity)
DSC
TGA
Dynamic Vapour Sorption
Hot stage microscopy
IR and NIR spectroscopy
Particles engineered to meet the needs of your process — not processes redesigned to accommodate particle shortcomings.
Particle attributes — purity, size, shape and surface characteristics — are directly linked to formulation quality, and determine how a drug substance behaves during processing and manufacture.
We design and engineer crystallisation processes that deliver the particle properties your programme needs. And if an existing process is underperforming, we identify the root cause and fix it.
The goal is always to deliver particles and processes that behave consistently and predictably, from lab scale through to commercial manufacture, and formulations that don’t rely on compensatory workarounds.
Capabilities
Solubility and metastable zone width curve measurement
Process design, optimisation and scale-up (1mL–5L automated lab reactors)
Wet and dry milling
Spherical crystallisation and co-processing
Process analytical technologies (Mettler Toledo FBRM™, BlazeMetrics BlazeBasic™)
Filtration and drying studies
Chemical and physical product characterisation
Characterisation that connects particle properties to product performance, from individual particle behaviour to bulk powder properties.
We go well beyond the standard characterisation toolkit, providing interpretation and context around not only particle size and shape, but surface properties and bulk powder properties as well. By understanding how particles interact with each other you can begin to correlate specific particle attributes with real manufacturing outcomes such as flow, compaction and sticking.
Whether you’re designing a robust process from the ground up or troubleshooting unexpected behaviour, the right characterisation data turns uncertainty into confidence.
Capabilities
Particle size measurement, method development, validation and AMTE (dry and wet dispersion)
Particle shape distribution and agglomeration assessment
Polarised light microscopy
Atomic force microscopy
Surface area and porosity
Surface energy
Bulk, tapped and true density
Fit-for-purpose formulation design, built from fundamental understanding.
Effective formulation starts with knowing the particle properties of the API. Using a Quality by Design framework, we develop fit-for-purpose formulations for solid oral dosage forms that are bioavailable, stable and appropriate for the stage of development.
Where a formulation is underperforming, we trace the problem to its root cause — which is often found in the underlying particle properties — and address it there.
The result is formulations built for predictable performance, from development through to manufacture.
Capabilities
Flow measurement
Formulation development including compressibility and sticking propensity
Mechanical sieving
Granulation
Tablet press
Hardness, friability and tensile strength testing
Disintegration testing
Want the full picture of our instrument suite?
Download our equipment list to see a comprehensive overview of the characterisation and analytical capabilities available at Particology.
Read to discuss
your programme?
Whether you have a specific challenge in mind or are still working out where to start, we’re happy to talk it through.