Spray Drying
With Guided Tour at the Hovione Site (Workshop is fully booked)
Im Auftrag der ECA Academy

Programm

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

Analytics and characterisation of spray dried products

• Short Overview of Solid dispersions
• Analytical tools
• Novel screening methods – single droplet spray drying
• Screening protein formulations
• Understanding cohesion/adhesion balances
• Correlating structure with performance

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

Development of Scaleable Spray Drying Processes for Solid Drug Product Manufacture
The presentation starts from the target properties of pharmaceutical intermediates and products for oral solid dosage forms and for dry powder inhalation, viewing SD as a particle design tool. Examples of various product types, such as amorphous drug substances, solid dispersions, granulates and inhalable powder, are given. SD is then compared to other drying/ agglomeration processes more common in the pharma industry. A systematic approach for development of products/ processes by means of spray drying is illustrated. , A special focus is given to the scaleability of the SD processes.

Scale-up of a Spray Drying Process
The bench scale spray drying units can be found in most of the material characterisation and drug development teams, being also used as production units of high-value low-volume drugs. However, it is often underestimated the valuable information that lab experiments can give to help in a successful process scale-up. In this presentation a scale-up methodology will be presented where insight will be given on what and how lab scale data can be used, as well as, how scaling-up can be used to improve product properties.

• Usage of lab scale data and lab-scale limitations
• Product improvement during scale up
• Scale-up methodology
• Process development strategy

Trouble Shooting Session
In this interactive session, all the key elements of the preceding lectures are
brought together.
What to do if:

• Particles are too fine/coarse
• Yield is too low
• Final product moisture content is too high
• Different product characteristics after scale up

Amorphous Solid Dispersions – Manufacturing Technologies

Case Study: PAT Technology for Spray Drying

• PAT to support a theoretical spray dry model in scale-up
• FDA’s request for PAT to ensure product quality
• In line measurement of particle size and relative saturation

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

Supporting the development of oral dosage forms with Spray Drying

• Specific challenges of the formulation of Amorphous Solid Dispersions into tablets
• Bridging spray drying and tablet development
• Advantages and challenges of integrated ASD tablet development

Case study: Application of Spray Drying for Inhalation Products

• Critical quality attributes: an overview for composite formulations via spray drying
• Spray drying process: Thermodynamics aspects specific of Inhalation products
• Spray drying process : Atomization aspects (controlling particle size and morphology)
• Composite DPI formulations through spray drying