Fundamentals of Spray Drying
- Identification of Critical Process Parameters
- Control of those Process Parameters
- Influence of these Process Parameters on Product Quality
- Example of setting up a Spray Drying Process
Spray Drying from a Particle Perspective
- Gas temperature and humidity
- Drying at particle level
- Stickiness (time, temperature and humidity)
- CFD models and drying kinetic analysis
Spray Drying vs Freeze Drying – How to Choose the Right Technique?
- Spray Drying of Pharmaceuticals
- Formulation via spray drying
- Scientific basics
- Review of spray-dried pharmaceutical products
- How to conclude: Spray Drying or Freeze Drying
Spray Drying, an Enabling and Versatile Technology – From Solubility Enhancement to Dry Powder Inhalation
- Overview of spray drying applications in the pharmaceutical industry
- Spray drying as an enabling technology for low solubility APIs and pulmonary delivery
- Bridging particle engineering, formulation and performance
Scale up of SD Processes – How to Develop a Robust Commercial Process
The scale-up of a spray drying process is often considered a resource-intensive challenge requiring large quantities of expensive drugs. Nevertheless, the use of a proper scale-up methodology overcomes this difficulty by the adoption of suitable mathematical modelling tools and lab experimentation approach. This presentation will focus on:
- Scale up methodology
- Establishment of scale-independent correlations
- Modelling tools for spray drying development
- Troubleshooting during scale up
Case Study Sanofi: PAT for Control and Optimisation of a Large Scale Spray Dryer
An optimised process for spray drying often operates close to boundaries of failure. Operating close to these boundaries requires well-controlled critical process parameters and critical product attributes.
- Development of timely, meaningful, and reliable measurements
- Practical examples of using PAT tools in spray drying
Integration of Quality-by-Design into Qualification and Validation of Spray Drying Processes
- Development of spray drying process using Quality-by-Design
- Design of Experiments (DoE)
- Critical Process Parameters
- Critical Material Attributes
- Risk assessments:
- Spray Drying Process
- Spray Dryer Design
- Qualification and Validation of a Spray Dryer
- Process Validation
- Scale-up
- Control Strategy
- Special tests during qualification and validation
Enhancing the Bioavailability of Poorly Soluble Drugs Using Spray Drying: Amorphous Solid Dispersions
- Introduction to ASD
- Manufacturing technologies (focusing on spray drying and melt extrusion)
- Case studies
Spray Drying of Biopharmaceuticals
For biopharmaceutical formulations, spray drying has only been used sparingly with freeze drying being the overwhelming choice as drying technology. However, over the last decade several developments within the pharmaceutical industry have taken place resulting in spray drying becoming a more accepted technology and more generally considered as an feasible technology for drying of biopharmaceuticals. In the presentation the challenges in spray drying of biopharmaceuticals will be discussed together with the possible solutions to overcome these.
- Biopharmaceuticals vs. Small Molecules
- Traditional Biopharmaceutical Drying Processes
- Spray Drying of Biopharmaceuticals
- Oral Delivery
- Parenteral Delivery (Aseptic Spray Drying)
- Outlook for Biopharmaceutical Drying Processes
Addressing the Analytical Challenges of Spray dried materials
- The importance of a reliable evaluation of physical stability;
- Quantifying improvements in solubility – biorelevant assessment of in vitro performance