Course10310678460 lectures
Pharmaceutical Crystal Engineering for Design, Development and Scale-up for Pharmaceutical Solids
Prof. Dinesh Kumar · IIT (BHU) Varanasi
About
The course will cover all aspects of the subject including crystallization of active pharmaceutical ingredient, intermediates as well as final products. In addition, precipitations and amorphous solids will be covered and the differences between amorphous solids and crystalline solids will be discussed. Solid state pharmaceutics supporting advanced characterization tools are included as well. Upon the completion of the course, student shall be able to apply scientific principles to the design and development of pharmaceutical crystallization processes.
Intended audience: UG PG students interested in pharmaceutical crystal engineering and solid-state pharmaceutical characterization
Prerequisites: Basics understanding of crystals, crystal engineering, solid pharmaceutical formulations
Lectures
Week 1
- Introduction to Crystallisation Terminologies
- Crystalline Solids - Introduction & Types
- Stages of Crystallization
- Crystal Growth Theories & Solubility
- Metastable Zone Width MSZW & Ostwald Steprule
Week 2
- Crystallization Basics & Types of Crystalline Materials
- Crystallization Process, Methods of Crystallization, Factors Affecting Crystallization
- Evaporative Crystallization
- Anti Solvent Crystallization
- Melt Crystallization, Crystallization of Chiral Compounds
Week 3
- Phases & Phase Diagrams
- Yield & Productivity of Pharmaceutical Crystallization Process
- Filtration, Washing & drying after crystallization
- Miscellaneouse facter for Desigen a Crystallization Process
- Problems due to Improper Process Design and Industrial Aspects
Week 4
- Batch vs Continuous Crystallization
- Crystallizers Used in Continuous Crystallization
- Cooling Continuous Crystallization
- Continuous Manufacturing in Pharma Industry
- AI ML in Pharmaceutical Manufaturing and Pharma Indusary 4 0
Week 5
- Polymorphism & It's Impact on Prarmaceutical Properties
- Disappearing Polymorphs & Mechanisms of Polymorphic Interconversion
- Methods of Polymorph Screening
- Solid State Characterization of Polymorphs
- Effect of Polymorphism on Pharmaceutical Processing
Week 6
- Basic Introduction, History, Type of Cocrystals
- Prerequisite Criteria for Coformers Selection to Design Cocrystals
- Compution Approaches for the Selection of Coformers
- Laboratory Methods for Sereening of Cocrystals
- Application, Characterization & Regulatory Aspects of Cocrystals
Week 7
- Introduction, Thermodynamics & Pharmaceutical Importance of Hydrates or Solvates
- Classification of Hydrates
- Kinetics & Mechanism of Dehydration or Hydration
- Preparation & Characterization of Hydrates & Solvates
- Stability & Regulatory aspects of Hydrae Solvates
Week 8
- FTIR Spectroscopy for Solid State Pharmaceutics
- XRD for Solid State Pharmaceutics
- Electon Diffraction & ssNMR Application in Pharmaceuticals
- Raman Spectrocopy for Solid State Pharmaceutiecs
- Solid State UV & Surface Free Energy Calculations
Week 9
- Introduction to Thermal Analysis & Its Applications in Pharmaceutical Industry
- Applications of DSC in Pharmaceutical Industry
- Practical Considerations & Celibration of DSC
- Thermolravimetric Analysis & Its Applications in Pharmaceuticals
- Isothermal Microcalorimetry, Hot Stage Microscopy & Dynamic Vapor Sorption Analyis
Week 10
- Quality by Design QbD for DS & DP Manufacturing
- Process Analytical Technology PAT
- Other PAT Tools, Benefits & Industrial Concerns
- Pharmaceutical Crystallization Scale up & SUPAC
- Process Safety in DS & DP Manufacturing
Week 11
- Physicochemical Characterization of Pharmaceuticas Solid Forms
- Impact of Amorphous forms on Pharmaceutical Properties
- Mechanical Studies of Pharmaceutical Solid Forms
- Impact of Pharmaceutical Solid forms on Powder Flow Properties
- Advancements in Solid Particle Size & Shame Measurements
Week 12
- Stability Studies of DS and DP
- Stability Testing Aspects of Formulation Development and Preformulation Studies
- API Coprocessing Introduction and Routes of Coprocessing
- Molecular Modelling & Simulation studies for Polymorph & Crystal Habit
- Molecular Modelling & Simulation studies of Amorphous Solid Dispersions & Cocrystals
Syllabus and materials
At NPTEL, as the course publishes them.
Credits and licence
- Institution
- IIT (BHU) Varanasi
- Department
- Chemical Engineering
- Teacher
- Prof. Dinesh Kumar
- Level
- Undergraduate
- Language
- English
- Subjects
- Chemistry, Engineering
- Source
- NPTEL
- Licence
- CC BY-NC-SA, as NPTEL states it. Non-commercial use only. NPTEL's terms
- Attribution
- NPTEL states: "Distributed under Creative Commons Attribution-ShareAlike / CC BY - NC - SA", beside a BY-NC-SA badge. Coordinated by IIT Madras.
- Who can watch
- NPTEL gives no rating. Invisible Network shows it to Tweens profiles and older, judged from what the source says about it. How courses are placed