Oral Solid Dosage Forms Oral Solid Dosage Forms

Transcrição

ECA
EUROPEAN COMPLIANCE
ACADEMY
Speakers
Erich Battanta
Novartis Pharma
Dr Urs Flury
Pharmaconduct
Günter Körblein
Senior Advisor in
Pharmaceutical Technology
Dr Rob Lammens
Technical Services Consult
Lammens
Oral Solid
Dosage Forms
Manufacture – Technology –
Compliance
Dr Jean-Denis Mallet
Formerly Head of the French
Pharmaceutical Inspection
Department
Barcelona, Spain
26 – 27 May 2009
Prof Dr Jean Paul Remon
University of Gent
Dr Harald Stahl
GEA Pharma Systems
Prof Dr Klaus-Jürgen
Steffens
University of Bonn
Dr Michel Ulmschneider
F. Hoffmann - La Roche
PD Dr Karl Gerhard
Wagner
Boehringer Ingelheim Pharma
Pre-Conference Course
Compile your own set of lessons
Fundamentals of granulation
Fundamentals of tabletting
highlights:

Approach to continuous processes: the total line
Trouble-shooting in the solida production
Hot stage extrusion and injection moulding
Multiple Unit Pellet System: MUPS Tablets
Effervescent and Multi Layer Tablets
Recent developments in Rotary Tabletting
Compaction Simulators for Formulation Development
GMP Inspection of Solida-Facilities
Use of Low-cost Equipment made in Far East
News from ACHEMA Exhibition
Objectives
This conference aims at informing about recent technologies in the manufacture of
oral solid dosage forms and how state-of-the art processes are to be designed to be
efficient and compliant and how trouble-shooting in production can be carried out.
Background
Solid dosage forms are still the most common dosage form, first and foremost tablets
with a portion of over 50%. Tablets are the least expensive dosage form, have a good
stability and open up adjustable possibilities of drug release. But although tabletting
is used since 1843 there are still open questions and problems in the daily routine.
Development and production of oral solid dosage forms with optimised therapeutic
attributes is as well as the implementation of stable and cost efficient processes of
large importance. Modern techniques like compression simulation, chemical imaging, NIR and multivariate data analysis can be used to overcome problems in daily
business.
Continuous processing
Fundamentals and expertise of tabletting and granulation
Trouble shooting using the multivariate approach
Special tablet forms
Adjusting release behaviour
Compaction simulation
Usage of low cost-equipment from far east
GMP Compliance in the Solida Factory
A deeper understanding of the basics of galenics of solid forms as well as detailed
expert knowledge will help to optimise the quality of daily work and during troubleshooting to solve production problems:
Target Audience
This event is designed for all managers and executives from Pharmaceutical Development, Production and Quality Assurance, responsible for development, transfer
or manufacture of solid dosage forms.
Moderator
Günter Körblein, Senior Advisor in Pharmaceutical Technology
Social Event
Pre-Conference Course
Fundamentals of Tabletting
Fundamentals of Granulation
On Tuesday, 26 May 2009, you are cordially invited to a
social event. This is an excellent opportunity to share
your experiences with colleagues from other companies in a relaxed atmosphere.
Your are an expert in tabletting, but not in granulation, or vice versa ?
Then take advantage of the Pre-Conference Course and complete your knowledge
of pharmaceutical technologies.You can choose between different lessons in granulation and compression and compile the ideal content for you. The Lessons are
designed to raise your knowledge from basic to deeper understanding.
The specific types of equipment will be discussed as well as working principles,
challenges during scale-up and trouble shooting in production environment.
Compile your own set of lessons:
Please choose three out of these six lessons; one lesson from each line
Tabletting Basics
or
Dry Granulation Basics
Granulation Basics
or
Basics of Tabletting with Single Stroke
Presses:
Eccentric presses, Pneumo Hydraulic
presses and Compaction Simulator
Basics of Tabletting with Rotary or
Tablet Presses
Basics of Wet Granulation: Fluid bed
and High Shear granulators
Conference Programme
Wet Granulation – Why and How Continuous?
Introduction
„Continu-Phobia“ – a Pharmaceutical Phenomenon?
The History – Justifications and Solutions
Why a Continuous Hype Today – Novel Techniques
The Beginning – Multi-Component Supply
Solutions for Granulation
Solutions for Drying
Blending-in Lubricants – The Stumbling Block
The “Total-Line” – Approach, Fiction or Reality?
Conclusion
Operating principle of various types of compaction simulators
Aspects of rotary presses to be simulated
Mimicking force time signals and punch movements of various rotary presses
Using a laboratory rotary press in formulation development and/or trouble
shooting
Comparing dwell time and total densification times of various rotary presses
Influence of speed of densification on tablet properties
−− Recognizing problems related to densification speed early in development
−− Using tensile strength and tablet porosity instead of hardness and compaction
force
Instrumenting compaction simulators
−− Requirements to precision and accuracy of force and displacement measurements
−− Ejection force, Residual force, Take off force
−− Measurement examples
−− Determining deformation behaviour of API’s/powders from Heckel Plots
Solving problems related to
−− Capping, laminating, sticking
−− Adhesion upon bilayer tabletting
Simulated and real “Force-Time-Profiles” of selected rotary presses
Comparing “Force-Hardness-Profiles” from a simulator and selected rotary presses
Influence of punch format on tablet properties
Containment, WIP/CIP aspects
Data-analysis for Process Understanding: multivariate approach
Added value of data-analysis & chemometrics
Measuring techniques for use in trouble shooting and root cause investigations
Short introduction to NIR
PCA – Principle Component Analysis
Chemical Imaging
Data-mining
Examples of applications
−− Identification & qualification of raw materials
−− Assessing dissolution issues
−− Evaluation and use of data
Recent developments in Rotary Tabletting
Features of recent tablet presses
−− Tooling
−− Containment
−− New Force Feeder
Latest Developments and Highlights from ACHEMA Exhibition
Multiple Unit Pellet System: MUPS Tablets – Principles, Processes, Limits
Formulation principles
Influence of compression on the release characteristics of coated pellets
Distribution and deformation of pellets within the tablet matrix
Minimising of film damages
Uniformity of content and mass
Fraction and seize of single units and their influence on tablet and mixture
characteristics
Programme (cont.)
Effervescent and Multi Layer Tablets
Challenges and solutions when manufacturing effervescent tablets
External lubrication
Challenges and solutions when manufacturing multi layer tablets
Machine concepts for the manufacturing of multi layer tablets
In depth discussion of the Bi layer compression cycle
Control and monitoring during compression of multi layer tablets
Hot Stage Extrusion and Injection Moulding
Introduction
−− Process
−− Materials
Formulation design
−− Oral drug delivery
−− Trans-drug delivery
−− Implants
Conclusion
Low-cost Equipment made in Far East - Experiences from Engineering and
Operation
Presentation of low cost manufacturing and equipment sourcing strategy of a global
pharmaceutical company based on solid dosage forms. The example will be based
on two new sites in Singapore and India from Novartis. Further different operational
strategies will be analysed as well as evaluation criteria for equipment selections.
Finally execution success factors will be discussed.
Pharmaceutical production for solid dosage forms
Low Cost manufacturing strategic
Evaluation criteria for equipment sourcing
Cost comparison
Example of execution issues
Traditional Equipment
Images: Novartis
Low Cost Equipment
Inspection of Solida-Facilities
(Oral) Solid Dosage Forms : a differentiated picture, from powders to soft capsules
Identification of main risks linked with the production of Oral Solid Dosage forms
Specific Regulatory requirements related to solida manufacturing
Some typical points assessed during solida facilities inspections
Case studies and most frequent deviations observed
Conclusion
Speakers
Erich Battanta, Novartis Pharma AG
Erich Battanta has a master in process engineering from the ETH Zürich. His career in Novartis
began in 1996 in the engineering department where he was involved as Project Engineer and
later as Project before becoming the Project Manager for a new production facility in Grimsby.
Afterwards he became Project Manager for a new green field solid dosage facility in Singapore. Currently he is Head of Engineering ChemOps responsible for Engineering and capital
investments within global chemical operations of Novartis.
Speakers (cont.)
Dr Urs Flury, Pharmaconduct GmbH
Urs Flury has a master degree in Microbiology/Biochemistry and a PhD degree in Natural
Science He started his career at Sandoz in the global pharmaceutical production department
as Project Leader where he was involved in the launches of new pharmaceutical products
and introduction of new technologies. Afterwards he became Head of Pharmaceutical Production Department for Solid Dosage Forms at the Site Stein (CH) of Novartis Pharma. Later
on, as Head of Manufacturing Standards & Technology in Global Technical Operations, he
developed new Global Manufacturing Strategies for Drug Products. Since 2008 he runs his
own business as consultant.
Günter Körblein, Senior Advisor in Pharmaceutical Technology
Günter Körblein has a degree in Mechanical Engineering. He started his career at Pharma
Consult in 1971 and joined Roha Arzneimittel some years later. He worked for Sandoz Pharma
in Basel as Head of Divisional Engineering. He joined Boehringer Ingelheim afterwards as
Head of Corporate Division Technology and finally worked for Uhde were he was Director
Marketing Uhde-Pharma. Now he works as Senior Consultant for the German Government
and the United Nations.
Dr Rob Lammens, Technical Services Consult Lammens
Dr Lammens studied Physical Chemistry and performed his PhD in Pharmaceutical Technology, before he joined the Pharmaceutical Technology Department of Bayer AG at Leverkusen
in 1981. Since 2001 he is a senior lecturer at the Pharmaceutical Technology Department of
the University of Bonn and is running the company Technical Services Consult Lammens.
Dr Jean-Denis Mallet, Formerly Head of the French Pharmaceutical Inspection Department
Jean-Denis Mallet is a doctor pharmacist, graduated in technological pharmacy (IPI) and
management (ISMA). He is currently a GMP auditor within the International Committee of the
Red Cross (ICRC). He was previously the Head of the Pharmaceutical Inspection Department
at the French Health Products Regulatory Agency (Afssaps). He also used to work in or with
the pharmaceutical industry during 12 years at various positions including QA, Production
Management, Engineering and GMP Consulting.
Prof Dr Jean Paul Remon, University of Gent
Prof. Dr. Jean Paul Remon is professor of Pharmaceutical Technology at the Faculty of Pharmaceutical Sciences of Ghent University. He has been Dean of the Faculty and Chairman of the
Department of Pharmaceutics since 1997. He is co-author of more than 320 international
publications and 17 patent/patent applications. The main field of research is solid dosage
forms more specifically: wet granulation, pelletilisation, hot stage extrusion, spray drying,
nasal powder delivery and veterinary dosage forms.
Prof. Dr. Klaus-Jürgen Steffens, University of Bonn
Prof.. Steffens holds a chair in Pharmaceutical Technology at the University of Bonn. He is an
expert in the development and production of solid dosage forms. The physicochemical characterization of raw materials and final products is one of his most important research fields
with more than 20 years experience in special analytical tools, among them spectroscopic
methods like NIRS and XRD.
Dr Harald Stahl, GEA Pharma Systems
Dr Harald Stahl worked the Pharmaceutical Development of Schering AG in Germany, where
worked on the the aseptic production of pellets. Since 1995 he served within GEA Process
Technology in various positions. Presently he owns the position of a Senior Pharmaceutical
Technologist of GEA Pharma Systems. He has published more than 20 papers on various
aspects of pharmaceutical production.
Dr Michel Ulmschneider, F. Hoffmann - La Roche AG
Michel Ulmschneider graduated in physical chemistry and is member of the PAT and analytical business process group in Basel. He has been at the forefront of the development of
quantitative near-infrared spectroscopic methods. His extensive experience in the field of
NIR and chemometrics led him to habilitate ate the University de Haute-Alsace in 2000.
PD Dr Karl Gerhard Wagner, Boehringer Ingelheim Pharma GmbH & Co. KG
Karl G. Wagner studied pharmacy and gained his PhD in pharmaceutical technology. After an
academic scholarship at the University of Texas he worked at the University of Tübingen at
the institute for pharmaceutical technology. After his postdoctoral lecture qualification he
joined Boehringer Ingelheim in Biberach and became head of the laboratory for galenic
research, modified release. He still holds the position of an external lecturer at the University
of Tübingen with the main research on modified release dosage forms.
Easy Registration
Form:
 Reservation
CONCEPT HEIDELBERG

P.O. Box 10 17 64
69007 Heidelberg
Germany
Reservation Form:
+ 49 6221 84 44 34
Internet:
@ e-mail:
[email protected]  www.gmp-compliance.org
Date Pre-Conference Course
Tuesday, 26 May 2009, 09.00 – 12.30 h
(Registration and coffee 08.30 – 09.00 h)
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in
the conference hotel. You will receive a room reservation form
when you have registered for the conference. Please use this form
for your room reservation or be sure to mention "VA 6040 ECA
Event" to receive the specially negotiated rate for the duration of
your stay. Reservation should be made directly with the hotel not
later than 14 April 2009. Early reservation is recommended.
Date Conference
Tuesday, 26 May 2009, 13.30 – 18.30 h
(Registration and coffee 13.00-13.30 h)
Wednesday, 27 May 2009, 08.30 – 15.30 h
Venue
nh-Hotel Constanza
C/Deu i Mata, 66-69
08029 Barcelona, Spain
Tel +34 93 2811500, Fax +34 93 4100335
Conference Language
The official conference language will be English.
Fees Pre-Conference Course & Conference
Non-ECA Members EUR 1,890,- per delegate plus VAT
ECA Members EUR 1,700.- per delegate plus VAT
APIC Members EUR 1,795.- per delegate plus VAT
(does not include ECA Membership)
EU GMP Inspectorates EUR 945.- per delegate plus VAT
The conference fee is payable in advance after receipt of invoice and
includes conference documentation, dinner on the first day, lunch on both
days and all refreshments. VAT is reclaimable.
Fees Conference
Non-ECA Members EUR 1,490.- per delegate plus VAT
ECA Members EUR 1,340.- per delegate plus VAT
APIC Members EUR 1,415.- per delegate plus VAT
(does not include ECA Membership)
EU GMP Inspectorates EUR 745.- per delegate plus VAT
The conference fee is payable in advance after receipt of
invoice and includes conference documentation, dinner on the first day,
lunch on the second day and all refreshments. VAT is reclaimable.
Organisation and Contact
ECA has entrusted Concept Heidelberg with the organisation of
this event.
CONCEPT HEIDELBERG
P.O. Box 10 17 64
69007 Heidelberg, GERMANY
Phone +49 (0) 62 21/84 44-0
Fax +49 (0) 62 21/84 44 34
E-mail: [email protected]
www.concept-heidelberg.de
For questions regarding content:
Dr Robert Eicher (Operations Director) at +49-62 21/
84 44 12 or per e-mail at [email protected].
For questions regarding reservation, hotel, organisation etc.:
Ms Marion Weidemaier (Organisation Manager) at +49-62 21/
84 44 46 or per e-mail at [email protected].

If the bill-to-address deviates from the specification
to the right, please fill out here:
Reservation Form (Please complete in full)
+49 6221 84 44 34
Oral Solid Dosage Forms, 26 – 27 May 2009, Barcelona, Spain
* Optional Pre-Conference Course on 26 May 2009: Please choose three out of the
six lessons; one lesson from each line
*
Tabletting Basics
or*
Dry Granulation Basics
*
Granulation Basics
or*
Basics of Tabletting with Single Stroke Presses
*
Tabletting with Rotary Tablet Presses or*
Basics of Wet Granulation
* Mr
* Ms
Title, first name, surname
Company
Department
CONCEPT HEIDELBERG
P.O. Box 10 17 64
Fax +49 (0) 6221/84 44 34
69007 Heidelberg
Germany
Important: Please indicate your company’s VAT ID Number
Purchase Order Number, if applicable
Street / P.O. Box
City
Zip Code
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General terms and conditions
If you cannot attend the conference you have two options:
1. We are happy to welcome a substitute colleague at any time.
2. If you have to cancel entirely we must charge the following processing fees: Cancellation
until 2 weeks prior to the conference 10 %,
until 1 weeks prior to the conference 50 %
within 1 week prior to the conference 100 %.
CONCEPT HEIDELBERG reserves the right to change the materials, instructors, or speakers without
notice or to cancel an event. If the event must be cancelled, registrants will be notified as soon as
possible and will receive a full refund of fees paid. CONCEPT HEIDELBERGwill not be responsible for
discount airfare penalties or other costs incurred due to a cancellation.
Terms of payment: Payable without deductions within 10 days after receipt of invoice.
Important: This is a binding registration and above fees are due in case of cancellation or nonappearance. If you cannot take part, you have to inform us in writing. The cancellation fee will then
be calculated according to the point of time at which we receive your message. In case you do not
appear at the event without having informed us, you will have to pay the full registration fee, even if
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participate in the conference (receipt of payment will not be confirmed)!
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