Screening tells you which forms exist. Selection tells you which one to develop. We run the comparative programme that turns a list of crystal forms into a defensible decision.
For the selection of the optimal API, several solid forms may be available from one molecule. We provide an effective comparative programme leading to better orientation and targeted selection of the optimum solid form with the requested properties.
Once a form is selected, the formulation, the manufacturing process, the analytical methods, the stability programme and the regulatory dossier are all built on top of it. Changing form later means repeating much of that work, and explaining the change to a regulator. This is the point in development where a few weeks of comparative data buy a great deal of certainty.
Selection is not simply picking the most soluble form. The right form is the one that balances solubility and dissolution against physical stability, chemical stability, hygroscopicity, manufacturability and intellectual property position — weighted according to the route of administration and the target product profile.
Every candidate form is put through the same programme, so that differences in the data reflect differences in the forms rather than in how they were tested.
Comparative in vitro studies are less variable than in vivo work, easier to control, and predictive of in vivo bioequivalence — which makes them the efficient way to rank forms early.
The dissolution profile of each form, measured under identical conditions, including biorelevant media where the development stage justifies it.
Evaluation at different temperature and humidity conditions, to establish which forms hold and which convert, and on what timescale.
Identification of the best physical form to carry into preformulation, taking particle properties and handling behaviour into account.
Assessment of filtration, drying, milling and compression behaviour, because a form that cannot be processed is not a candidate whatever its solubility.
A ranking against your target profile, with the trade-offs made explicit rather than buried in an appendix.
The programme is designed around the decision you need to make, and around the forms that screening actually produced.
We agree with you what the selected form has to achieve — solubility target, stability requirement, dosage form, route of administration — before designing the comparison.
Each candidate form is prepared at a scale and purity that makes the comparison meaningful, and confirmed by diffraction before testing begins.
Dissolution and intrinsic dissolution measurements are run on all candidates under identical conditions, with biorelevant media where appropriate.
Thermodynamic and kinetic solubility measured across the relevant pH range, which frequently separates candidates that look equivalent in a single medium.
Candidates are placed under controlled temperature and humidity conditions and monitored for form conversion, chemical degradation and moisture uptake.
Particle characteristics, flow, compaction and behaviour on drying and milling are evaluated for the leading candidates.
The data are assembled into a comparative matrix and a reasoned recommendation, discussed with your development team.
Selection draws on the analytical laboratory as heavily as on the solid-state one, because the decision rests on quantitative comparison.
The deliverable is a detailed technical-scientific report built around the comparison, so that the selection can be presented and defended as it stands.
Yes. If a screening was carried out by another laboratory or in-house, we can take the identified forms and run the comparative programme on them. We would characterize each form on arrival first, to establish that what we received is what the report describes.
In vitro bioequivalence studies are less variable, easier to control and predictive of in vivo bioequivalence. They allow several forms to be compared rigorously and at reasonable cost, before committing animal or human studies to a single candidate.
That is a useful result, and it usually arrives early enough to act on. The next step is normally salt or co-crystal screening, or an amorphous solid dispersion, depending on the molecule. We would discuss the options rather than simply report the shortfall.
Timelines depend on the scope agreed with you — the number of conditions explored, the techniques required and the depth of characterization. We define the duration together with the study plan, before work begins, and keep you updated as results come in rather than only at the end.
The quantity depends on the type of study and on how many conditions and techniques are involved. We tell you the exact amount when we scope the project, and we design the experimental plan to work with the material you have available.
A detailed technical-scientific report: experimental conditions, raw analytical data, interpretation and conclusions, written so that it can be used directly in your development documentation and regulatory filings.
Work starts only after a confidentiality agreement is in place. Samples, data and reports remain yours, and results are never shared or reused. We routinely handle undisclosed structures and early-phase candidates.
Tell us which forms you have and what the selected form has to achieve. We will design the comparative programme around that decision.