GRANULATION – FROM POWDER TO TABLET JUNE 07 to 09, 2011„EXPERT OF SOLIDS“ CertificationSeminar 2
www.oystar.huettlin.de
Objective of this seminarFollowing the seminar the participant will have a clear
understanding of the granulation process and the critical
issues. The participant will be able to perform a granulation
process in the high shear mixer, in the fl uid bed and in
its combination.
Course No. 6-GRA-0611
GRANULATION – FROM POWDER TO TABLET – JUNE 07 to 09, 2011Seminar 2 – „EXPERT OF SOLIDS“ certificated by OYSTAR HÜTTLIN
Today granulation is still the core process in the production of solid dosage forms. For this reason the second seminar of „EXPERT OF SOLIDS“ is focused on drying and granulation.
On the first day participants are introduced to the granulation process, flow properties and critical parameters will be explained. Participants will have the opportunity to familiarise themselves with the equipment for wet granulation.Day two begins by focusing on analytic and excipients used for granulation and the link to compression of the granules.After lunch participants sign in special interest groups and are working on small granulation projects.The third day will start on with the topic trouble shooting and a case study about granule properties. The seminar will close with a presentation of the group results.
Day One June 07, 201108.00 – 08.15 Registration 08.15 – 08.30 Introduction + Welcome M. Knöll (OYSTAR Hüttlin)08.30 – 10.30 Introduction, defi nitions/method of tablet A. A. Sakr (Univ. of Cincinnati U.S.A.) production focus on wet granulation This presentation will cover a brief overview of the basics for tablet design and
formulation. The properties and “intelligent” choice of tablet excipients for specifi c tablet
properties and the ideal characteristics of compressed tablets will be discussed. A brief
comparison between the technologies of tablet manufacturing will be conducted with
special emphasis on wet granulation.
10.30 – 10.45 Coffee Break 10.45 – 11.30 Basics of Hüttlin technology and process selection M. Knöll (OYSTAR Hüttlin) Basics of the function of the fl uid bed and high shear mixer. Thermodynamical basics
of drying and of the fl uid bed. Comparison between fl uid bed and dry oven. Comparison
between fl uid bed and high shear mixer granulation. Advantages and disadvantages
both methods and how to select the right process.
11.30 – 12.00 Analytical methods for In Process Control (IPC) H. Meyer (SOTAX GmbH) of granules and tablets The in-process control for the pharmaceutical production and development is still the
recognized standard to assure quality and to maintain process understanding. The most
frequent used characteristics are fl ow and the density of granules and friability, hardness,
shape and disintegration for tablets. The presenter will give a technical overview of the
methods and the equipment. Also the benefi t of automation will be highlighted.
12.00 – 13.00 Lunch Break13.00 – 14.30 Process parameters of high shear and M. Knöll (OYSTAR Hüttlin) fl uid bed granulators Parameters infl uencing the granulating process and how to use them for process control.
14.30 – 14.45 Coffee Break 14.45 – 17.45 A practical introduction to the granulation M. Knöll, R. Sill (OYSTAR Hüttlin) process using a high shear mixer and A. Hartung, M. Frank (OYSTAR Hüttlin) a fl uid bed combined with analytical methods D. Schulze (Univ. Braunschweig) The participants will be divided into several groups and will be introduced to the wet
granulation process, the analysis and the compression of the granules.
17.45 Transfer to hotel19.15 Pick-up for dinner
Day Two June 08, 201108.30 – 09.30 Tablet development and the role of excipients E. Stoyanov (JRS Pharma) The presentation describes some of the most used tabelt excipients and their advantages
and disadvantages in the tablet development, differences in wet granulation and direct
compression as well as some case studies.
09.30 – 10.15 Tablet manufacturing by direct compression J. Croenlein (Colorcon GmbH) This presentation provides an overview of direct compression as one of the simplest and
cheapest methods of tablet manufacture. A comparison is made of the formulations
produced by both fl uid bed and high shear granulation to the direct compression approach
using an amlodipine besylate formulation. Two DC case studies are also discussed for
cyclobenzaprine hydrochloride and sucralfate formulations.
10.15 – 10.30 Coffee Break 10.30 – 11.15 Tabletting and compression F. Oprach (Sandoz) The calculation and use of dwell times for production and validation in compressing
of solid dosage forms. The use of compression hardness profi les for a better process
understanding, set-up of compressing machines and justifi cation of process limits.
Impacts of the fi lling curve and the rotary feeder on the product quality of the tablets.
11.15 – 12.00 Benchmark of binders for wet granulation T. Cech (BASF) The focus of the presentation is to show, using the most popular wet granulation tech-
niques (bowl and fl uid bed), the performance of the most commonly used pharmaceutical
wet granulation binders. Since the properties of the fi ller material has a strong impact
on the granulation process, model fi ller materials such as Lactose, Ca-Phosphate and
Microcrystalline cellulose were used in the placebo formulations.
12.00 – 13.00 Lunch Break13.00 – 13.30 AccuSpray B. A. Helsdon (OYSTAR Manesty) “AccuSpray“ a new technological milestone from OYSTAR Manesty is a process for
applying a lubricant fi lm that has been designed to radically cut magnesium stearate
concentrations. With this technology magnesium stearate consumption can reduce
from an average of 100 g per production hour to as little as 4 g. It‘s particularly promising
for effervescent and orally disintegrating dosage forms, which dissolve rapidly in water
without forming any residue.
13.30 – 17.30 Special interest group for different granulation processes All Every participant can sign in a special interest group for the granulation process, likewise
for fl uid bed granulation or high shear mixer granulation.
17.30 Transfer to hotel19.15 Pick-up for dinner
Day Three June 09, 201108.30 – 09.30 Trouble shooting M. Frank (OYSTAR Hüttlin) Typical problems in fl uid bed and high shear processes are shown and different
solution methods are presented.
09.30 – 10.30 Infl uence of particle size and moisture onto A. Hartung (OYSTAR Hüttlin) the compression of granules Particle size and residual moisture but also the moisture pattern during the granulation
can have infl uence on the compression properties from granules. Based on case studies
correlation are presented.
10.30 – 10.45 Coffee Break 10.45 – 11.15 Preparation of the presentation All 11.15 – 12.00 Presentation of results from the project groups and wrap up All
12.00 – 13.00 Lunch
„EXPERT OF SOLIDS“ AND „MASTER OF SOLIDS“ CERTIFICATED BY OYSTAR HÜTTLINWho should attend?
Professionals engaged in development or production of solid dosage forms.
Description
The „EXPERT OF SOLIDS“ (four seminars, certificated by OYSTAR HÜTTLIN) is the preliminary stage of the „MASTER OF SOLIDS“ (additional two seminars, certificated by OYSTAR HÜTTLIN).
All aspects of development and production of solid dosage forms will be highlighted from the basis of granulation, via the experimental design to the compression of the tablets. A „MASTER OF SOLIDS“ will gain detailed knowledge in manufacturing solid dosage forms.
Individual courses on „EXPERT OF SOLIDS“ can be taken.
Scale-Up QbD
GranulationValidation of
Cleaning Process
certifi cated by OYSTAR HÜTTLIN
ExperimentalDesignCoating
MASTER OF SOLIDS
EXPERT OF SOLIDS
VALIDATION OF CLEANING PROCESSES OCTOBER 21 to 22, 2009 „EXPERT OF SOLIDS“ CertificationSeminar 1
www.oystar.huettlin.de
Course No. 2-VCP-1009
Objective of this seminarFollowing the seminar the participants will have a clear
understanding of the cleaning process and the critical issues.
The participant is able to create a cleaning SOP and to perform
a cleaning validation.
GRANULATION – FROM POWDER TO TABLET JUNE 17 to 18, 2009„EXPERT OF SOLIDS“ CertificationSeminar 2
www.oystar.huettlin.de
Objective of this seminarFollowing the seminar the participant will have a clear
understanding of the granulation process and the critical
issues. The participant will be able to perform a granulation
process in the high shear mixer, in the fl uid bed and in
its combination.
Course No. 2-GRA-0609
COATING – FINE PARTICLES, GRANULES, PELLETS, TABLETS NOVEMBER 18 to 19, 2009„EXPERT OF SOLIDS“ CertificationSeminar 3
Course No. 1-COA-1109
www.oystar.huettlin.de
Objective of this seminarProviding solutions to all types of challenges you face in
day-to-day coating business. Answers to the topics of taste
masking, preparation of solid dispersion, coating of pellets,
coating of tablets and the dissolution of these dosage forms.
The participant will be able to perform hands on coating
processes on the OYSTAR equipment.
STATISTICAL DESIGN SPACE DEVELOPMENT – FROM DESIGN OF EXPERIMENTS TO GRANULESFEBRUARY 17 to 18, 2010„EXPERT OF SOLIDS“ CertificationSeminar 4
Course No. 1-DOE-0210
www.oystar.huettlin.de
Objective of this seminarThe target of this seminar is to combine the theory of DoE
(statistical and mathematical aspects) with a practical
workshop (production of granules). We combine theoretical
knowledge with data from real granulation trials.
As a result of this seminar the participant will feel confi dent
in things like QbD, Design Space, Six Sigma and Capability
– quality systems for their operations improvement.In cooperation with
Our AddressHüttlin GmbHHohe-Flum-Strasse 4279650 SchopfheimGermanyP +49 7622 68 84 0F +49 7622 68 84 [email protected]
Please sign up to the seminar by fax, e-mail or download the PDF file from our homepage.
REGISTRATION FORM COURSE NO. 6-GRA-0611Granulation – From powder to the tablet – Seminar 2 in Schopfheim
Surname
Position
Company
Street / P.O. Box
Postcode
Phone
Date, Signature
First Name Title
Department
Industrial Sector
Location, Country
Fax
Your Contact PersonDr. Marcus KnöllP +49 7622 68 84 [email protected]
Price for Seminar1250€ (excl. VAT), 10% reduction for participants from a previous course(Inclusive: lunches and beverages during the seminar and dinner on the first and second day)
As soon as we receive your registration form we will send an invoice to you with our banking details and more detailed information on the seminar.
Please reserve single / double room(s) for night / nights from to .
Please organize a taxi transfer from the airport to the hotel / to OYSTAR Hüttlin and back.
(Flight information will be forwarded to Hüttlin as soon as possible.)
I will arrive by car.
The reservations are limited. Reservation is confi rmed when we receive full payment.
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• Heinrich Meyer GermanyHeinrich Meyer studied Chemistry at the Westfälische Wilhelms-
Universität of Münster/Germany. In 1995 he got a Ph.D. in Analytical
Chemistry at the University of Münster/Germany. He started his business
career as Product Specialist for Servomex, a British manufacturer of
analytical equipment for process control. From 2002 to 2010, he worked
for Büchi Labortechnik,fi rst as Sales Engineer and later on as Sales
Manager Germany. In 2010, he joined SOTAX, a Swiss company providing
solutions for pharmaceutical testing. As Sales and Marketing Manager
Germany he is responsible for the German territory.
• Dr. Frank Oprach Switzerland Dr. Frank Oprach studied Pharmacy in Braunschweig (Germany) and made
his theses with a topic in Pharmaceutical Biology (1987). He joined the
former Ciba-Geigy in Wehr (Germany) in the same year. Frank headed
from 1987 to 1995 different departments for QA/QC (Raw Materials,
Analytical Control of Finished Dosage Forms, Analytical Development)
and took over increased responsibilities as Qualifi ed Person, as well
as for the Microbiological Labs. From 1995 Frank became Department
Head for Solid Dosage Forms, Liquids and Semi Solids. From 2000 to
2002 Head of Pharmaceutical Development. From 2002 to 2006 Project
Team Leader for launches of solid dosage forms in Stein (Novartis
Pharma, Switzerland). Since 2006 Manager for Pharmaceutical Processes
for Sandoz AG, Basle.
• Dr. Edmont Stoyanov Germany Dr. Edmont Stoyanov graduated Pharmacy at the Medical University
in Sofia/Bulgaria. He holds his Ph.D. in the field of Organic and
Pharmaceutical Chemistry focused on the synthesis design, isolation
and analysis of novel biologically active substances. He worked fi ve
years as senior assistant professor in the industrial pharmacy depart-
ment at the Medical University of Sofi a and published over 30 papers
in the fi eld of organic and pharmaceutical chemistry. As Alexander von
Humboldt Research Fellowship holder, realized Mr. Stoyanov an own
project about a new microwave-assisted method for the preparation of
organic compounds. Edmont holds several patents on different subjects
like poly-functional formulating agents, ionic liquids and new application
of solid dose excipients. Dr. Stoyanov joined JRS Pharma Germany in
2006 as senior scientist and expert.
YOUR SPEAKERS
• Andrea Hartung GermanyAndrea Hartung studied Pharmacy from 2003 till 2007 at J. W. Goethe
University of Frankfurt / Germany. After her graduation she started as
a Ph.D. student in the group of Prof. Peter Langguth at the Johannes
Gutenberg University of Mainz /Germany in cooperation with OYSTAR
Hüttlin, Schopfheim / Germany. Her Ph.D. study is on granulation and
tabletting processes using statistical applications e.g. DoE to optimize
them. Furthermore she is experienced in Process Analytical Technology
– a new FDA approach, using timly controlled “inline” measurements
e.g. Near infrared spectroscopy for controlling critical process parameters
such as moisture and other particle attributes.
• Thorsten Cech GermanyThorsten Cech studied process technology (with a focus on pharma-
ceutical technology) at the University of Applied Sciences in Bingen/
Germany. During fi ve years at Knoll AG, he was consigned for the
development of solid oral dosage forms using melt extrusion technology.
Subsequently, he worked for fi ve years in the R&D development of OTC
products at Boehringer Ingelheim Pharma GmbH & Co. KG. Since 2005,
he has been responsible for the European Pharma Application Lab
of BASF SE in Ludwigshafen/Germany. His responsibility is the appli-
cation support concerning customers requests in the European region.
• Dipl.-Ing. (FH) Joerg Croenlein GermanyJoerg Croenlein holds a degree in Chemistry from Technical College
Fresenius, Wiesbaden/Germany. Parallel to his studies, from 1990 to
1994, he gained experience in analytics at Fresinus Institute, Taunusstein.
From 1995 to 1999 he worked for Boehringer Ingelheim in the Pharma-
ceutical Development department. Since 1999 he has been working
for Colorcon GmbH as Head of Laboratory and is currently holding the
position Area Technical Manager and Modifi ed Release Technologies.
• Brian A. Helsdon Great BritainAs an engineer with over 40 years experience of OYSTAR Manesty
products, Brian Helsdon has an extensive knowledge of the tableting
equipment gained for many years of working within the production and
engineering departments at OYSTAR Manesty in a number of senior
roles. In his current position he is responsible for OYSTAR Manesty‘s
customer training worldwide. He also lectures on tablet compression
technology, tablet coating equipment and tablet tooling.
• Dr. Marcus Knöll GermanyMarcus Knöll is a pharmacist and graduated from Philipps Universität
Marburg/Germany. After a six months research internship at University
of Florida/USA he accomplished his doctoral thesis „Enteric coated
Mucoadhesive Micropellets in Rotary Agglomeration Process for
Wet Spheronization“ (2002-2005). He is Head of Pharma Service at
OYSTAR Hüttlin, Schopfheim/Germany since 2005 with four co-workers.
• Manfred Frank GermanyManfred Frank has a degree in Engineering of Technical Physics and
worked for more than nine years as Project Engineer in R&D at AEG
and Endress&Hauser. Since 1990 he is the Head of Laboratory at
OYSTAR Hüttlin, Schopfheim/Germany and has nearly to 20 years
of experience in the fi eld of solid dosage forms. He is an expert in
development of formulations and processes for granulation and
coating. Manfred Frank combines knowledge of R&D with production.
• Prof. Dr. Dr. h. c. Ahmed Adel Sakr Saudi ArabiaAhmed Adel Sakr is Emeritur Professor at the Univ. of Cincinnati U.S.A.;
academic and international advisor to the board of trustees of Future
University, Egypt. He co-authored over 160 internationally published
research papers and presented more than 400 conference presentations,
invited presentations and/or courses. Prof. Sakr is an elected fellow
of AAPS and graduate fellow of the Univ. of Cincinnati. He is the
recipient of the Distinguished Faculty Achievement Award of this
University. Prof. Sakr is Emeritus Congress Chair, FIP-Industrial
Pharmacy Section and is the recipient of the 2008 AAPS Outstanding
Pharmacy Educator Award.
