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.
Triclinic’s solid-state chemistry services include 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 while retaining solid-form development as the primary program framework.
Solid-form development service areas
Use these solid-state chemistry services 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, solid-form development should begin before toxicology studies whenever practical. Early characterization reduces the risk of discovering more suitable or problematic forms after major investments have been made in formulation, process development, clinical studies, or regulatory submissions.
Why is solid-form development more than polymorph screening?
Polymorph screening is one part of a broader investigation. Solid-state chemistry services may also evaluate salts, cocrystals, hydrates, solvates, amorphous materials, crystal habit, particle properties, and the effects of manufacturing and environmental conditions on form stability and performance.
How comprehensive should screening be, and how do we know when it is sufficient?
Scope should reflect the molecule, development stage, dosage form, manufacturing process, and scientific and commercial risk rather than a fixed checklist. Screening is sufficient when it provides a defensible understanding of the relevant solid-state landscape, supports form selection, identifies credible transformation risks, and establishes controls appropriate to the next development stage.
What are the risks of inadequate solid-form development?
Insufficient characterization can contribute to unexpected phase transformations, stability failures, manufacturing variability, dissolution changes, delayed regulatory submissions, and missed intellectual-property opportunities. Early, decision-focused work reduces the likelihood that these issues will emerge after formulation, scale-up, or clinical commitments.
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. Solid-form data can support CMC documentation, manufacturing controls, regulatory justification, and IP or lifecycle strategy when the work is scoped to the required evidence level. Reports should distinguish confirmed findings, interpretations, limitations, and residual risk. Patentability and other legal conclusions remain matters for qualified counsel.
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.
What distinguishes a development partner from a routine analytical laboratory?
A development partner does more than generate analytical data. Effective support integrates crystallization science, analytical characterization, pharmaceutical development, regulatory understanding, and scientific interpretation so the results guide form selection, manufacturing, formulation, risk control, and lifecycle decisions.
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.
