What a dossier is
This is a real dossier skeleton - the same sections, tables, and tags a licensee receives - for a de-identified asset (a poorly soluble, immediate-release oral solid). Compound name, formulation values, and reference data are masked; the structure, provenance grading, and simulation evidence are exactly what ships.
Section 1 / asset summary & claims table
| Claim | Provenance | Specimen value |
|---|---|---|
| Reference product, dosage form, strength | Verified | [molecule] · IR tablet · [strength] |
| Label composition (all excipients) | Verified | DailyMed SPL + PMDA Interview Form |
| IID maximum-potency caps per excipient | Verified | FDA IID, retrieved [date] |
| Quantitative excipient targets, % w/w | Inferred | Latent composition model, ranges per region |
| Reference dissolution profile, compendial media | Verified | FDA review figure, digitized |
| Critical process parameter windows | Hypothesized | From simulation gates + equipment class |
| Predicted in-vivo equivalence (Cmax, AUC) | Inferred | Virtual-BE screen, GMR + 90% CI |
| Pilot-batch size and design for first BE study | Hypothesized | Trial-1 optimization output |
Section 2 / master formula
| Component | Function | mg/tablet | % w/w | Grade / cap |
|---|---|---|---|---|
| [API] | Active | [x] | [x] | Micronized / SDD per asset class |
| [Filler] | Diluent | [x] | [x] | IID cap [x] mg |
| [Binder] | Binder | [x] | [x] | Pharmacopoeial grade |
| [Disintegrant] | Disintegrant | [x] | [x] | Within PMDA-reported range |
| [Lubricant] | Lubricant | [x] | [x] | IID cap [x] mg |
| [Coating system] | Film coat | [x] | [x] | Weight-gain target [x]% |
Section 3 / manufacturing procedure (step-by-step)
Every Lawsone dossier writes the procedure as unit operations in order - the sequence a plant executes, not a narrative. Each step carries its equipment class, critical process parameters, in-process controls, and hold times.
| Step | Unit operation | Equipment class | CPPs / IPCs |
|---|---|---|---|
| 1 | Sift API + intragranular excipients | Vibratory sifter | Mesh [x]; IPC: no agglomerates |
| 2 | Dry mix | High-shear granulator | [x] min at impeller [x] rpm; IPC: blend uniformity |
| 3 | Granulate (binder solution) | High-shear granulator | Endpoint: pore saturation window [x-x]; IPC: LOD [x]% |
| 4 | Dry | Fluid-bed dryer | Inlet [x]°C; IPC: LOD ≤ [x]% |
| 5 | Mill + blend extragranular phase | Comil + bin blender | Screen [x] mm; blend [x] min; IPC: BU RSD ≤ [x]% |
| 6 | Lubricate | Bin blender | [x] min; IPC: no over-lubrication (dissolution drift) |
| 7 | Compress | Rotary press | Hardness [x-x] kp; weight variation per Ph.Eur.; IPC: friability ≤ [x]% |
| 8 | Film coat | Perforated pan coater | Bed [x]°C; weight gain [x]%; IPC: appearance, thickness |
| 9 | Package | Blister / bottle + desiccant | Moisture barrier per shelf-life gate output |
Section 4 / specifications & equivalence evidence
| Test | Method | Acceptance criterion |
|---|---|---|
| Appearance | Visual | Per description |
| Assay | HPLC | [x]-[x]% of label |
| Related substances | HPLC | Impurity limits per ICH/RLD profile |
| Dissolution | USP apparatus [x], [x] mL, [x] rpm | Q=[x]% at [x] min; profile f2 ≥ 50 vs reference |
| Content uniformity | USP <905> | AV ≤ 15.0 |
| Water / LOD | KF / LOD | ≤ [x]% |
The evidence package that follows the spec table: the f2 comparison tables (re-checkable with our public f2 calculator), the virtual-BE screen output, PBPK exposure estimates where the compound supports them, the Monte-Carlo robustness report, and the shelf-life gate projection under the dossier's specified packaging.
What the dossier does not claim: identity with the innovator's batch record. Reconstruction is bounded, tagged, and auditable - and the final equivalence confirmation remains a pilot batch and a BE study, which the dossier designs and de-risks.