Polymorphism
Screen, identify, rank, and control polymorphs, hydrates, solvates, and late-appearing forms that can affect development and manufacturing.
Solid-form development services for form selection, control, manufacturability, and IP strength.
This section summarizes Triclinic’s solid-form development pages: polymorphism, pharmaceutical salts, cocrystals, amorphous materials and ASDs, crystallization method development, habit and morphology engineering, patent-strength assessment, and manufacturing troubleshooting. The goal is to connect form discovery and characterization to decisions in formulation, CMC, scale-up, quality, and lifecycle strategy.
Solid-form development service areas
Use these pages to choose the right starting point for a molecule, material, or manufacturing problem. Each service page focuses on a different way solid form can affect solubility, stability, crystallinity, manufacturability, formulation behavior, patent position, or process control.
Pharmaceutical Salts
Evaluate counterions, crystallinity, solubility, hygroscopicity, stability, and disproportionation risk for ionizable APIs.
Cocrystals
Screen and develop multicomponent crystal forms, including coformer selection, phase behavior, stoichiometry, and salt-versus-cocrystal classification.
Amorphous Material Development
Support amorphous API and ASD approaches through crystallinity, Tg behavior, recrystallization risk, humidity response, and matrix-specific analysis.
Crystallization Method Development
Translate form selection into practical crystallization conditions that control form, purity, particle attributes, isolation, and drying.
Habit and Morphology Engineering
Connect particle habit, morphology, surface, size, and flow behavior to filtration, handling, dissolution, and manufacturability.
Patent Strength Assessment
Evaluate whether solid-state claims are experimentally supported, reproducible, distinguishable, and defensible.
Manufacturing Troubleshooting
Investigate form conversion, lot variability, dissolution drift, OOS results, stability failures, contamination, and process-driven material changes.
How to use this section
Start with the decision point. Early development may need polymorph, salt, cocrystal, or amorphous screening; later stages may require crystallization control, morphology engineering, manufacturing troubleshooting, or patent-strength assessment.
Common Questions
When should solid-form development start?
Ideally before toxicology or clinical commitments, and certainly before formulation lock, scale-up, filing, or lifecycle decisions depend on an inadequately characterized form.
Which solid-form service should I start with?
Start with the service that matches the immediate decision: form discovery, salt or cocrystal selection, amorphous strategy, crystallization control, morphology, patent strength, or manufacturing failure.
Can the work support CMC, manufacturing, regulatory, or IP decisions?
Yes, when the study is scoped to the evidence level required and the report separates confirmed findings, plausible interpretations, limitations, and residual risk.
How much material is needed?
Material needs depend on the question, the number of conditions, the techniques used, detection limits, and whether the work is exploratory, confirmatory, cGMP-capable, or litigation-supporting.
Which analytical techniques may be used?
Technique selection depends on the molecule and decision. Programs may use XRPD, DSC, TGA, DVS, Raman, FTIR, microscopy, Karl Fischer, chromatography, NMR, SCXRD, MicroED, dissolution, stability, and particle-characterization methods.
Plan your solid form program
Share the API, available material, current form information, prior data, development stage, and the decision the solid-form work must support.
