Week 1: Introduction to various solid-state forms of APIs and their application, Principles of pharmaceutical crystallisation, aims of crystallisation, solubility, turbidity, supersaturation, and the metastable zone and metastable zone width, nucleation and crystal growth
Week 2: Methods of crystallization, cooling crystallisations, evaporative crystallisations, anti-solvent crystallisation and melt crystallisation, crystallisation of chiral compounds/resolution
Week 3: Crystallisation design/case studies, designing a crystallisation process, phase diagrams (binary/ternary), Key crystallization parameters, troubleshooting, Industrial examples
Week 4: Continuous crystallization and continuous manufacturing, Pharma industry 4.0, Basic application of AI/ML in pharmaceutical manufacturing with case studies
Week 5: Polymorphism, polymorph screening, characterising polymorphs, regulatory aspects of polymorphs, and Disappearing polymorphs
Week 6: Co-crystals, the applications of co-crystals, prerequisite criteria in terms of chemistry and physicochemical properties to find an ideal co-former, screening methods, characterization methods, regulatory aspects
Week 7: Solvates and hydrates, characterization of solvates and hydrate, amorphous solids
Week 8: Spectroscopic and diffraction methods of analysing the solid states, Infra-red, Raman, XRPD, Single crystal-XRD, Electron diffraction crystallography (only introduction), identification and differential characterization of physical mixtures, co-crystal and co-amorphous systems
Week 9: Thermal and microscopic methods of analyzing solid-state DSC, TGA, HSM
Week 10: PAT tools, Equipment Considerations and Scale Up
Week 11: Physicochemical characterization of pharmaceutical crystals/co crystals/co-amorphous/solvate/hydrate systems including solubility, powder dissolution, intrinsic dissolution, and mechanical study like indentation, fracture pattern, crack, CTC profiling (compressibility, compactability, Tabletability). Advancements in the solid particle size (sieving. Optical microscopy, electron microscopy, crystallite size by XRD, AI/ML integration, wet/dry methods) and shape (impact of sphericity, aspect ratio, Morphology G4 and other parallel equipment’s) distribution measurements
Week 12: Stability study and formulation development with crystalline materials, Co-processing of active pharmaceutical ingredients, Molecular modelling and simulation studies for polymorphism, crystal habits, amorphous, and co-crystals
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