Moisture Analyzer

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Moisture Analyzer Course
Introduction:
Course Objectives:
Through laboratory practice and lectures, the course is designed to allow participants to:
- Develop an overall understanding of the science and technology of solid dosage forms processing
- Explore concepts of scale up, process validation, product evaluation and FDA regulatory requirements
- Learn or review principles in the technologies of development, production and quality control including QbD and PAT
- Gain hands-on experience in planning, processing and testing uncoated / coated tablets
- Work and exchange ideas with faculty and other participants
Who Should Attend?
This course presents an in-depth study of tablet processing including an extensive laboratory program. It emphasizes the industrial application of the development, processing and quality control functions. It is suitable to introduce this operation to technical personnel from research, development, production and quality control, as well as administrators, FDA investigators or other individuals who need an introduction to tableting.
Course Outlines:
The topics to be covered in the lecture portion of the course include:
- Preformulation techniques
- Formulation Selection
- Near Infrared Spectroscopy
- Mixing and Blending
- Granulation and Drying Principles
- Powder Compression and Compaction
- Excipient Uses and Case Studies
- Physical Evaluation of Tablets
- Introduction to Coating and Sugar Coating
- Film Coating
- Scale up Considerations for Granules and Tablets
- Process Validation
- SUPAC Guidelines
- Stability and Expiration Dating - FDA Requirements
- Bioequivalence - FDA Requirements
- Laboratory Content
LAB 1 (Preformulation)
- Particle Size Reduction & Analysis
- Density (true)
- Surface Area and Porosity Measurement
- Moisture Adsorption/Desorption Isotherms
- Spray-Drying of Potent Drug
- Determination of Particle Size Distribution by Sieve Analysis
- Determination of Bulk and Tapped Densities
- Determination of Dynamic Flow Rate
LAB 2 (Granulation)
- High Shear Mixing and Wet Granulation
- Hot-melt Granulation
- Extrusion – Spheronization
- Fluid-Bed Drying
LAB 3 (Tableting and Granulation)
- Tablet Compression
- Generation of Hardness – Compression Profiles
- Roller Compaction
LAB 4 (Coating)
- Fluid-Bed Granulation
- Particle and Tablet Coating Using Fluid-Bed
- Tablet Coating Using a Pan Coater
LAB 5 (Quality Control)
- Near Infrared Spectroscopy
- Tablet Evaluation (Dissolution, Disintegration, Friability)
- Laboratory Facilities
- Participants will have the opportunity to use state-of-the-art equipment’s including:
- Micromeritics Surface area analyzer, Particle size analyzer, Density analyzer, Particle Insight
- VTI Corporation Moisture Sorption Analyzer
- Surface Measurement Systems DVS Intrinsic Moisture Sorption Analyzer
- Buchi Mini Spray Dryer
- Gilson Autosiever, Vector Pan Coater
- LCI Extrusion-Spheronizer
- Collette High shear-mixer/granulator
- Retsch Ball-milling/particle grinding equipment
- Fitzmill Comminutor
- Niro Fluid bed dryer/coater
- Elizabeth-Hata Tablet press and Tester
- Vector TFC Labo Roller Compactor
- Glatt Fluid bed dryer/coater
- Vector pan coating coater
- Hanson Disintegration Tester
- PION Rainbow Dynamic Dissolution Monitor System
- Distek and Hanson Corporation USP Dissolution equipment
- PerkinElmer Lambda 20 UV Spectrophotometer
- Foss NIRSystems NIR equipment