Build the API’s physicochemical profile and formulation boundaries (pH–solubility, cosolvency/surfactancy map, solid-state and Tg behavior, excipient compatibility) to de-risk ODF design and scale-up.
Scope / Methods
Solubility in 0.1N HCl, pH 1.2/4.5/6.8 (37 °C); pH–S curve; intrinsic solubility where needed.
Cosolvent/surfactant screening with EtOH/PG/PEG400 (0–40% v/v) and polysorbates/poloxamers (0–1%).
Compatibility with HPMC/PVA/pullulan/gelatin/alginate and plasticizers at 40 °C/75%RH for 2–4 weeks.
DSC for Tg/Tm/crystallinity; FTIR for H-bond/salt/inclusion; PXRD (optional) for polymorph.
Hydrophilicity: contact angle, uptake, aw to anticipate disintegration and hygroscopic risks.
Inputs: API COA & basic properties; target dose/load; target market; masking/ excipient constraints.
Deliverables: Preformulation report with curves/maps/matrices, DSC/FTIR with interpretation, shortlists & actionable recommendations; raw data.
Timeline / Material: 7–10 business days; API 1–3 g.
QC / Acceptance: Replicates RSD ≤10%; ≥2 implementable formulation routes.
Instruments: UV/HPLC, DSC, FTIR, contact-angle meter, incubator; ICH Q8/9/10 framing.