Spray Drying - Live Online Training Solutions for the Pharmaceutical Industry

15/16 March 2022

Course No 19455

This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager". Learn more.

All times mentioned are CET.

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Speakers

Dr Sune Klint Andersen, Janssen Pharmaceutica
Dylan Jones, formerly Sanofi
Paulo Lino, Hovione FarmaCiencia
Dr Tiago Porfirio, Hovione FarmaCiencia
Dr Thomas Quinten, Janssen Pharmaceutica
Henrik Schwartzbach, Niro
Luis Sousa, Hovione FarmaCiencia
Dr Harald Stahl, GEA

Objectives

In this Live Online Conference you will get to know the different spray drying applications and what you have to consider when you implement them into your manufacturing process. You will learn

how to identify critical process Parameters
how to weigh up the pros and cons of spray drying and freeze drying and how to choose the right technique
how to scale up and develop a robust commercial SD process
how to control and optimize a Large Scale Spray Dryer
how to enhance the bioavailability of poorly soluble drugs by a SD technique

You will get first hand information by experts from industry. Benefit from their experience in applying the spray drying technology in the manufacture of various pharmaceutical products.

Background

Spray drying is presently one of the most exciting technologies for the pharmaceutical industry, being an ideal process where the end-product must comply with precise quality standards regarding particle size distribution, residual moisture/solvent content, bulk density and morphology.

One advantage of spray drying is the remarkable versatility of the technology, evident when analyzing the multiple applications and the wide range of products that can be obtained. From very fine particles for pulmonary delivery to big agglomerated powders for oral dosages, from amorphous to crystalline products and the potential for one-step formulations, spray drying offers multiple opportunities that no other single drying technology can claim.

Benefits of Spray Drying

High precision control over:
- Particle size
- Bulk density
- Degree of crystallinity
- OVIs and residual solvents
Typical application in pre-formulated products
- Microencapsulations
- Solid Solutions
- Improved bioavailability and stability
For products with unusual or difficult characteristics
- Sticky or hygroscopic products
- Slowly crystallizing products
- Difficult to isolate products
Rapid drying for temperature sensitive materials

Target Group

This Live Online Conference addresses specialists and executives working in the fields of pharmaceutical manufacture, research and development and quality control as well as technicians, planners and plant designers, especially those involved with the manufacture of powders and granules, as e.g. in the manufacture of solid dosage forms for oral or pulmonary administration.

Technical Requirements

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

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

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