Spray Drying - with Hands-on Spray Drying Course at GEA Niro

Spray Drying - with Hands-on Spray Drying Course at GEA Niro

Copenhagen, Denmark

Course No 17110


Costs

Non ECA Member: EUR 1990,--
ECA-Member: EUR 1790,--
EU/GMP Inspectorates: EUR 995,--
APIC Member Discount: EUR 1890,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Sune Klint Andersen, Janssen Pharmaceutica
João Henriques, Hovione
Dylan Jones, Sanofi
Prof Geoffrey Lee, Erlangen University, Germany
Mafalda Paiva, Hovione
Dr Tiago Porfirio, Hovione
Dr Thomas Quinten, Janssen Pharmaceutica
Henrik Schwartzbach,Niro A/S, Denmark
Dr Harald Stahl, GEA

Objectives

Take advantage of the opportunity to focus on spray drying technology and process and get a first hand demonstration of solutions for diverse requirements. Further, benefit from the practical day at the GEA Niro Site where you can get a hands-on experience in spray drying yourself. You will learn in small groups how the spray drying result is affected by different equipment, parameter changes, solvents etc.

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 analysing 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 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.

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
Spray Drying on Laboratory Scale
  •  Lab-scale & micro-scale spray dryers
  •  Design & process conditions
  •  Enthalpy calculations
  •  Advantages & limitations
  •  Examples
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
Hands-On Spray Drying Course on Thursday, 14 May 2020
On the third conference day you will have the opportunity to take advantage of an exclusive hands-on training. With that purpose three different spray dryers will be disposed at the GEA Niro Test Station. Experienced Trainers will lead you in very small groups, providing an intensive experience and directly applicable know-how.

You will see how different spray drying equipment, different solvents, products, and variation of process parameters affect the yield, residual moisture, bulk density and particle size. You will learn how to design feasibility studies, how to optimise production parameters and how to proceed a scale-up from laboratory to industrial scale. Furthermore, you will learn how to analyse and evaluate your product and the process by using methods like Laser Diffraction, Microscopy and LoD.

Target group of the Course:
Pharmaceutical Technologists Pharmaceutical Formulation Scientists Application Chemists Drug Development Engineers, Particle Design Engineers

Experiments
  • Labscale spray drying in once-through operation of aqueous/organic solvent applications under contained conditions and influence of process parameters on drying conditions
  • Upscale to pilot-scale spray drying of aqueous/organic solvent applications and influence of process parameters on particle size in closed-cycle operation
  • Upscale from pilot-scale to industrial scale spray drying of aqueous/organic solvent applications and influence of process parameters on particle size, bulk density and residual moisture/solvent content
A shuttle bus will bring you back to the hotel with a prior stop at the airport. Airport arrival is scheduled for approximately 16.15 h.
The course is held in very small groups, so number of participants is strongly limited. Early booking is recommended.

In certain cases participation in the workshop may not be possible due to competitive reasons.

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