01 — Characterise
The active first: solubility, stability, polymorphism, incompatibilities. Most formulation failures are traceable to something skipped here.
Pillar 01
A molecule that works in a flask is not yet a product. Formulation is the discipline that carries it the rest of the way.
The discipline
They are usually treated as three, solved in sequence by three different groups. The result is familiar: a formulation with excellent dissolution that degrades in month four, or a stable one that no production line can reproduce at scale.
We work the three together from the start. Characterise the active and what attacks it. Choose a matrix that protects it without impeding release. Check at every step that the thing can still be made in the quantity intended, on equipment that exists. It is slower at the beginning and considerably faster overall.
We work across both pharmaceutical and nutraceutical products, and treat the distinction between them as regulatory rather than scientific. A nutraceutical active obeys the same physical chemistry as a drug substance; the evidentiary burden differs, the rigour should not.
Capability
Engagements range from a single defined technical question to development of a formulation from the active outwards. In either case the deliverable is the same in kind: a documented result with its limits stated.
Method
The active first: solubility, stability, polymorphism, incompatibilities. Most formulation failures are traceable to something skipped here.
Matrix and excipient system chosen against explicit targets for release, stability and manufacturability, with the trade-offs written down.
Analytical methods developed alongside the formulation, so that every claim about it has a method capable of testing that claim.
Documentation and process understanding handed over in a form a manufacturing site can act on without reinterpretation.
Bring the problem and the data behind it. Technical conversations proceed under confidentiality as a matter of course.