Crystallization and Polymorphism studies
CRAMSN Research Park brings over collectively two decades of expertise in crystallization, polymorph screening, and solid-state development, backed by state-of-the-art infrastructure and advanced analytical capabilities. Our specialized services include polymorph screening, salt screening,Co-crystals and powder X-ray diffraction (PXRD) to ensure optimal solid-form selection for enhanced stability, bioavailability, and manufacturability.
In addition to polymorph development, we provide comprehensive physical property studies, morphological aspects including particle shape & size reduction, bulk density evaluation, and powder flow analysis and specific surface area etc. Our expertise in solid-state characterization and material science enables us to develop scalable and reproducible crystallization processes, ensuring high-quality drug development and manufacturing solutions.
Polymorph Screening
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Solvent Screening: Comprehensive evaluation at various temperatures to classify solvents as anti or co-solvents.
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Solubility & MSZW Analysis: Solubility curve generation and determination of Metastable Zone Width (MSZW) using PAT tools.
Crystallization and Polymorphism
Crystallization Studies: Experiments are conducted to determine process conditions for obtaining different solid forms, including solvated, non-solvated, hydrated, and hemihydrated morphs.
Crystallization Techniques: Various methods are employed for solid form screening, such as:
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Cooling crystallization
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Anti-solvent crystallization
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Seeding crystallization (seed point evaluation)
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Evaporative crystallization
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Spray drying
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Agitated thin film drying
Polymorph-slurry Mediated Transformations
Slurry-Mediated Transformation Studies: Test compounds are subjected to slurry experiments in organic solvents with optimal solubility, ensuring the presence of excess solid by adjusting slurring media, volume, and solid content.
Solid-Form Characterization: After slurring in organic solvents or aqueous mixtures, the remaining solid forms are separated and analyzed using PXRD, DSC, and TGA. Time points for experiments are determined as per requirements.
Crystallization Process Optimization
Crystallization Optimization with PAT: Techniques like FBRM (Focused Beam Reflectance Measurement) for real-time particle count and size distribution and PVM (Particle Vision Microscope) for online particle shape monitoring are used.
Process Finalization: Ensuring optimal yield and quality through refined crystallization conditions.
ATFD Studies: Conducted if required for amorphous forms and heat-sensitive materials.
Optimization of Filtration, Drying and Particle Size Distribution
Filtration & Drying Optimization: Scale-up studies are conducted to optimize filtration and drying conditions.
Particle Size & Milling Studies: Performed as needed to achieve desired particle size distribution.
Solid Stress Studies: Assess polymorph stability under milling and micronization conditions.
Advanced Infrastructure: Equipped with multi-mills, centrifuges, micronizers, and ANFDs for efficient processing.
Tangential Flow Filtration: Enables compound separation based on molecular weight.
