BACKGROUND

More and more pharmaceutical products are reaching the market as multiparticulate dosage forms, mainly as pellets. The healthcare sector also frequently selects pellets as  the optimal marketable form of functional food. As there are quite a number of existing techniques relating to the production of pellets, it is often very difficult for a  formulator or marketing manager to make a choice, since every technique claims to be optimal.
This workshop aims to elaborate the advantages and drawbacks of the individual techniques, focusing on the optimal spectrum of each one but also consider the economical and ergonomical aspects of manufacturing processes. On special request of various participants, this workshop has been extended to include lectures on the main excipients for pelletizing and pellet coating, on functional pellet coating, compression of pellets into tablets, capsule filling and the most suitable capsule materials. All speakers are specialized, experienced and renowned experts from science and industry.

WHO SHOULD ATTEND

Typically, operators and researchers from the pharmaceutical and related industries will get the most out of this workshop. However, the workshop is also perfectly suitable for those who want a detailed overview of fluidized bed technology in a short space of time.

SPEAKERS

Jochen Berger
Ecolab (Schweiz) GmbH, Switzerland

Dr. Guido Büch
Novartis, Switzerland

Dr. Anne Ettner
Glatt GmbH, Germany

Pascale Gauthier
Université d‘Auvergne France, France

Samira El Mafadi Jian
Novacaps, France

Dr. Norbert Pöllinger
Glatt GmbH, Germany

Dr. Florian Priese
Novartis Technical Operations – Solids, Germany

Dr. Dirk Schmalz
Harke Pharma GmbH, Germany

Dr. Karlheinz Seyfang
Harro Höfliger GmbH, Germany

Lilia Sprich
Glatt GmbH, Germany

Prof. Sven Stegemann
Technische Universität Graz, Austria

Philippe Tschopp
Glatt GmbH, Germany

MODERATION

Klaus N. Moeller
TTC Technology Training Center

Location & Organization

TTC – Technology Training Center

Regina Bernstein / Klaus N. Moeller / Bianca Nowak

Werner-Glatt-Straße 1, 79589 Binzen, Germany

Tel +49 7621 – 664 308

Fax +49 7621 – 664 798

E-mail ttc@ttc-binzen.de

DETAILS

• The participation fee is € 1.490,– (exclusive of VAT).
• This fee includes participation, accompanying course notes, daytime catering and dinner. Any other expenses
  are to be borne by the attendee.
• Free attendance granted to a limited number of students.
• Participation is limited. Registrations will be confirmed
  on a first come first serve basis.
• Courses taking place in Germany are subject to
  Value Added Tax (VAT).
• Each participant will receive a certificate of attendance
  at the end of the course.

TUESDAY, 10 OCTOBER 2017

12:00
Transfer from hotel to TTC

12:30
Reception and registration

12:50
Introduction, Klaus N. Moeller

13:00
Principles of pellet production & processing: pelletizing, layering and coating. Introducing the basics of pellet manufacturing focusing on pharmaceutical applications. Giving an insight into theoretical backgrounds, standard manufacturing operations und required equipment and starter materials to create various pellet types and sizes. Florian Priese

14:00
Identifying new opportunities for products using multiparticulates: Life cycle management, pediatrics, animals health and more. Biopharmaceutical, physiological,  economical, safety and intellectual property advantages have created opportunities favoring the use of pellets over monolithic systems. Highlighting how the unique size and modified release properties of pellets can contribute to a superior solution. Florian Priese

15:00
Coffee break

15:30
Innovative starter beads for multiparticulate dosage forms.
More and more neutral and functional starter cores are
available on the market. Presenting the different products
and their characteristics. Philippe Tschopp

16:00
Excipients for pelletizing in fluidized bed processes.
Providing an insight into the common excipients for various
fluidized bed processes such as granulation and coating
focusing on pelletization. Dirk Schmalz

16:45
Advanced continuous fluidized bed technologies for
pellets and micro pellets. Presenting various continuous
fluidized bed processes. Outlining the opportunities to
optimize product quality and reduce manufacturing costs.
Norbert Pöllinger

17:30
Transfer to Hotel

19:30
Workshop Dinner

WEDNESDAY, 11 OCTOBER 2017

08:40
Transfer from Hotel to TTC

09:00
From multiparticulates to tablets – overview of possibilities and form adaptations for products and users. Spheres are multiparticulates products but can be easily compressed to obtain single tablets. Providing an overview on their purpose and the advantages for the products and the users. Pascale Gauthier

09:45
Process optimization considering QbD and using DoE – The basis for successful scale-up. Process optimization is a prerequisite for successful scale-up and process validation. Presenting real-life examples: Applying Quality by Design and Design of Experiments. Guido Büch

10:30
Coffee break

11:00
Scale-up of particle coating in the fluidized bed –
Understanding the process. Scale-up is the transfer of a
process from lab-scale to manufacturing scale. Presenting the
scale-up concept of particle coating using Wurster technology
as an example. Explaining the scale-up of the most important
process parameters in detail. Norbert Pöllinger

11:45 MicroPx technology – how to produce high drug loaded micro
pellets. Norbert Pöllinger

12:00 Developing a Pellet Process from Laboratory Scale to
Commercial Scale – A Case Study. Finding the right process
technology for the target formulation is a prerequisite for successful
process development, scale-up and process validation.
Presenting real-life examples of how to apply this approach.
Anne Ettner

12:45 Lunch

13:45 Capsule filling techniques. Outlining the functional
principles of capsule filling machines and dosing systems for
multiparticulates. Explaining what to consider in terms of
critical product parameters and filling performance.
Reviewing solutions for 100 percent in-line verification of
dosed mass. Karlheinz Seyfang

14:30 From micro to commercial scale – A look at Equipment for
the Real World. Discovering the full range of state-of-the-art
fluidized bed units (factory tour).

Practical Session: The hands-on experience with pellets in GMP and technical lab environments

15:00
Introduction to the practical part, Lilia Sprich

15:15
Practical part

• CPS technology – the new fluidized bed rotor process for direct pelletisation
• Wurster fluidized bed pellet coating – state-of-the-art applications with an established technology
• Fluidized bed pellet coating – applying a new tangential spraying technology
• Capsule filling demonstration

Claudio Cortazzo, Björn Haepp, Karlheinz Seyfang

17:30
Transfer to hotel

19:30
Workshop dinner

THURSDAY 12 OCTOBER 2017

08:40
Check-out from hotel and transfer to TTC

09:00
Taking a fresh look on multiparticulates in the age of patient centric product design. Advances in medical and pharmaceutical sciences, demographic changes and the increasing demands in healthcare are challenging, longstanding paradigms in the pharmaceutical industry. Providing a new perspective on innovation through a known
formulation approach is food for thought and fresh ideas. Sven Stegemann

09:45
Dripping methods to produce pellets. Dripping consists in extruding a liquid as droplets and solidifying them. The presentation will review the methods, their advantages
and limits, as well as their potential for industrial or biomedical applications. Samira El Mafadi Jian

10:30
Coffee break

11:00
GMP compliant cleaning of pharmaceutical equipment. Overviewing procedures, regulations and specific equipment parameters for optimized cleaning with focus on oral solid dosing processes. Jochen Berger

11:45
Summary

12:00
Snack buffet and logout

12:30
Transfer to Basel, German Railway Station (Badischer Bahnhof), Swiss Railway Station (SBB) and EuroAirport

Download the Workshop Flyer as PDF File.