Before a molecule can be formulated, someone has to know how it behaves. We build the physicochemical picture that formulation, process and regulatory work will all be based on.
With broad experience in studying and modifying the physical, mechanical and chemical properties of an API, our goal is to select the proper form and enhance its performance to push it forward into animal and human trials.
Preformulation is where the properties that will govern the whole programme are established: solubility across the physiological pH range, stability toward heat, light, moisture and oxidation, compatibility with the excipients the formulation will use, and the particle and bulk properties that determine whether the material can be handled at all.
Work skipped here does not disappear; it resurfaces as a failed stability batch, an unexpected degradant or a blend that will not flow. The economics favour doing it properly and early, when the cost is analytical time rather than a repeated clinical batch.
The programme is assembled from the studies your development stage actually requires, not from a standard package.
Thermodynamic and kinetic solubility across the physiological pH range, with pKa and partition behaviour where they are relevant to absorption.
Forced degradation under thermal, hydrolytic, oxidative and photolytic stress, identifying degradation pathways and the conditions the molecule cannot tolerate.
Binary and multi-component compatibility studies, to identify excipient interactions before they appear in a formulation stability study.
Particle size and shape distribution, surface area, density, flow and compaction behaviour — the properties that decide whether the material processes.
Moisture sorption behaviour and its consequences for handling, packaging and storage.
Verification that the form remains unchanged through the studies, since a preformulation result on the wrong form is worse than no result.
The order matters: each study informs the design of the next, which is why we run them as a programme rather than as a list.
The API is characterized on arrival and its solid form confirmed, establishing the reference against which every subsequent result is interpreted.
Solubility is measured across the pH range, with pKa and lipophilicity determined where the development route requires them.
The molecule is stressed thermally, hydrolytically, oxidatively and photolytically. Degradants are separated and characterized, and the pathways identified.
Physical and chemical stability under controlled temperature and humidity, monitoring both chemical degradation and form conversion.
Binary mixtures with the intended excipients are prepared and stressed, with analysis for both chemical interaction and solid-state change.
Size, shape, surface area, flow and compaction behaviour are measured on the material as it will be used.
Results are assembled into a single technical-scientific report with the practical implications for formulation set out explicitly.
Preformulation spans the analytical and solid-state laboratories, and most questions are answered by combining the two.
The output is a detailed technical-scientific report that formulation and regulatory teams can work from without reinterpretation.
Form selection tells you which crystal form to use; preformulation tells you how that material behaves chemically, mechanically and in contact with excipients. The two are complementary, and the second is usually what formulation asks for.
Yes. Forced degradation is run with chromatographic separation and mass spectrometric detection, so degradants can be characterized and pathways proposed rather than simply counted.
Yes, and it is the normal situation at this stage. We prioritise the studies with the highest decision value for your programme and design them to consume as little API as the methods allow.
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.
Yes. Our facility is authorized to handle high-potency active pharmaceutical ingredients up to OEB5, and controlled substances under Ministry of Health authorization, under GMP certification issued by AIFA and following FDA inspection.
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 where the programme stands and what formulation needs to know. We will propose the studies that carry the most decision value at this stage.