- Date:
-
- Webinar
Granulation & Tableting - Live Online Training - GMP Compliance and Technology for the Manufacture of Oral Solid Dosage Forms
- Event location:
- online
- Organizer:
- CONCEPT HEIDELBERG GmbH
Fundamentals of Granulation – what is a good Granulate?
- Reasons for granulation
- Overview of the different granulation processes
- Impact of the single processes on the granulate properties
- Understanding the mechanisms of agglomeration
- Characterisation of granulates
- Excipients for granulation and their impact on product properties
Fundamentals of Roller Compaction / Dry Granulation
Dry granulation is gaining more and popularity in the pharmaceutical industry as it may offer advantages like fast development and Scale-Up, usability in continuous manufacturing operations and improved process control
Dry granulation is gaining more and popularity in the pharmaceutical industry as it may offer advantages like fast development and Scale-Up, usability in continuous manufacturing operations and improved process control
- Design aspects of a modern roller compactor
- Impact of process parameters like compaction force, gap, roll speed, roll surface, roll width and side seal system on ribbon properties
- Principles of densification: solid fraction as critical material attribute
- Scale-Up
Fundamentals of Fluidbed-Granulation
- Design aspects and working principle of a modern fluidbed-dryer
- Basic principle and advantages of fluidbed-granulation
- Impact of process parameters on product properties
- Process insights: how to run, control and design the process
Scale-Up of Fluidbed Granulation
- Which process parameter influences which product quality attribute
- How to scale-up?
- Consequences for the quality critical attributes
High Shear Granulation: Fundamentals
- Plant-geometry and -design
- Process parameters (degree of filling, impeller speed, liquid saturation, process time)
- Methods of drying
- Special Case: Single-Pot-Granulation
High Shear Granulation: Scale-Up
- Influence of impeller speed, liquid addition rate and wet massing time
- Review of end point detection methods
- Scale up trouble shooting
Wrap-Up: Overview and Comparison of the different Granulation Techniques
And Outlook
And Outlook
- Which technique for which kind of product: viewpoint of development
- Which technique for which product portfolio: viewpoint of production
- Comparison of direct and indirect cost: viewpoint of management
- Continuous Manufacturing
Tableting: Process, Equipment and Formulation
- Physical fundamentals of powder adhesion
- Compressibility and compactibility of different materials
- How to handle materials with unfavourable compression properties?
- Parts of tablet presses: their function and their impact on product properties
- Comparison of the different control philosophies
- Measurement of the deformation behaviour by compression analysers
- Overview and characterisation of the most important excipients used for compression
CAPS: A novel Co-Processing Approach to enhance ASD Properties
Controlled API-Polymer Solidification (CAPS) is a new, solvent-evaporation based technology for preparation of ASDs with superior physical properties, including improved density, flowability, and particle size distribution. In-vitro dissolution-permeation system, as well as in-vivo pharmacokinetic evaluations, demonstrated that CAPS-prepared ASDs exhibit bioequivalence to spray-dried formulations. This study highlights the advantages of CAPS, offering enhanced physical properties and simplified downstream processing compared to conventional ASD processes.
Controlled API-Polymer Solidification (CAPS) is a new, solvent-evaporation based technology for preparation of ASDs with superior physical properties, including improved density, flowability, and particle size distribution. In-vitro dissolution-permeation system, as well as in-vivo pharmacokinetic evaluations, demonstrated that CAPS-prepared ASDs exhibit bioequivalence to spray-dried formulations. This study highlights the advantages of CAPS, offering enhanced physical properties and simplified downstream processing compared to conventional ASD processes.
Scale-Up of Tableting Processes
- Compression issues during Scale-Up and Transfer Quality by Design helps to overcome Scale-Up issues
- Scale-Up and optimisation of compression processes
- Constant dwell time as Scale-Up approach: theory and practice
Global GMP Requirements for OSD Operations
- OSD Quality Attributes: from homogeneity to dissolution
- Pharmacopoeias and OSD : main monographs
- Requirements from the main guides: US, EU/PICS & WHO
- Requirements from special chapters: US, UK and France
Validation of a Tableting Process
- What are the main validation requirements?
- Tablets Quality Attributes and Tabletting Critical Parameters
- Establishing a protocol not forgetting intermediate steps
- Running the process not neglecting secondary operations
- Following tablets stability issues
Handling of highly Potent Materials – Containment for Tableting Processes
- How much containment is really needed?
- Identification of critical operations (with regards to exposition)
- Comparison of different containment concepts
- Examples of existing equipment
Trouble Shooting in Tableting Processes: Sticking, Capping & Lamination Reasons for Tableting Problems
- Possible changes & improvements in upstream processes
- Tips and tricks for production: possible changes within the existing equipment and registration environment
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Germany
Phone: +49 6221 844415
Fax: +49 6221 844464
email: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
