Workshops

Tablets and Capsules

(Manufacturing Technologies, Quality Assurance & Quality Control)
CHAIR: Prof. Dr. Dr. h.c. Adel Sakr (USA/KSA)
CO-CHAIR: Dr. Gabrielle Betz (SWITZERLAND)

About the workshop

The workshop is designed to provide the participants with a basic understanding of the following topics:

• Powder Handling
• Tablet Manufacturing Technologies
• Roll Compaction, Fluid Bed Technology, High Shear Granulation
• Scale Up
• PAT
• Tablet Design
• Processing of Potent Materials
• Tablet Presses: Press Parts, Setup, Operation, Maintenance, Troubleshooting
• Punches & Dies: Tooling Demonstration
• Capsule Filling Machines
• Quality Control/Quality Assurance, USP Specifications
• Concepts and Applications of Dissolution Testing

Learning Objectives

Upon completion of the workshop, each participant will be able to:

• Understand tablet press operation and  troubleshooting
• Understand TSM specifications and tooling options
• Understand the principles of operation for Tabletting equipment
• Understand the differences among the applications of  various tablet manufacturing techniques
• Design tablet formulations
• Design fluid bed technology protocols
• Understand granulation processes including the  influence of the process parameters on product quality
• Do troubleshooting on existing granulation processes
• Recommend the most suitable equipment for each of  the various unit operations used in Granulation,  Tabletting and Coating.
• Understand and solve manufacturing problems
• Understand the various formulation and  manufacturing factors that influence product quality.
• Understand the physico-chemical bases for  formulation.
• Understand the fundamentals of PAT
• Understand Quality Control/quality Assurance and USP specifications
• Understand the Concepts and Applications of  Dissolution Testing Biorelevant Dissolution, IVIVCs  and IVIVRs, and Dissolution Validation

Who should attend?

This workshop is designed to train a wide range of individuals involved with the design, formulation, manufacture, quality control and quality assurance of Pharmaceutical Tablets. Managers, supervisors, tablet press operators, tablet press maintenance technicians, granulation technicians, with experience and/or backgrounds in pharmacy, chemistry, biology, engineering and/or industrial technology will benefit from attending and actively participating in discussions during this workshop.

Workshop Agenda

February 7^th 2012

7:30—8:30	Registration/Sign-In
8:30—9:15	Introduction to Tablet Formulation  (Prof. Dr. Adel Sakr (USA, KSA))
9:15—10:00	A New Superior Excipient for Roller Compaction and Dry Granulation (Eng. Gregory Thoorens (BELGIUM))
10:00—10:15	Coffee Break
10:15—1:00	Methods of Tablet Manufacturing (Eng. Jeff Hoskinson (USA)) • Roll Compaction • Fluid Bed Processing • High Shear Granulation
1:00—2:00	Lunch
2:00—3:00	Tablet Press Set Up and Operation: Causes and Effects Eng. Doug Kirsch (USA)
3:00—4:00	Designing Tablets with Production Consideration In Mind Eng. Dale Natoli (USA)
4:00—4:15	Coffee Break
4:15—5:00	Insights Into the Tabletting Process Dr. Gabi Betz (SWITZERLAND)
5:00—5:45	Technologies for the Manufacture of “Patient Friendly” Dosage Forms Dr. John Tillotson (USA)

February 8^th, 2012

8:30—9:30	Scale Up in the ICH Q-9 Era: Application of Risk Management in Process Development Dr. Ehab Hamed (USA)
9:30—10:30	Using Mix Torque Rheometry in Pelletization Technology Dr. Mohamed Abbas Ibrahim (KSA)
10:30—11:00	Coffee Break
11:00—12:30	Gastro-Retentive and Pulsatile Drug Delivery Systems Polymer Coatings in Oral Extended Release Dosage Forms Prof. Dr. R. Bodmeier (GERMANY)
12:30—1:30	Lunch
1:30—2:30	Adjusting Desired Drug Release Kinetics from Ethyl Cellulose-Coated Pellets Pharm. Bruno Leclercq (BELGIUM)
2:30—3:30	Hard Capsule Filling Technology Eng. Fadhel Belaiba and Dr. Karlheinz Seyfang (GERMANY)
3:30—4:00	Coffee Break
4:00—5:00	Quality Control/Quality Assurance Prof. Dr. Adel Sakr (USA, KSA)
5:00—6:00	GMP Audit Pharm. Erik Naeser (SWEDEN)

February 9^th, 2012
CONCEPTS AND APPLICATIONS OF DISSOLUTION TESTING

9:00—9:15	Opening Remarks Prof. Dr. Sandra Klein (GERMANY)
9:15—10:30	Why Do We Do Dissolution Testing? Theoretical Background and Practical Aspects Prof. Dr. Sandra Klein (GERMANY)
10:30—11:00	Coffee Break
11:00—11:45	Setting of Dissolution Specifications Dr. Kerstin Pauli (GERMANY)
11:45—12:30	Selection of Dissolution Test Media Prof. Dr. Sandra Klein (GERMANY)
12:30—1:30	Lunch
1:30—2:30	Development of Dissolution Test Methods in the Pharmaceutical Industry Dr. Horst Dieter Friedel (GERMANY)
2:30—3:30	Biorelevant Dissolution Testing of MR Formulations: IVIVCs and IVIVRs Dr. Nikoletta Fotaki (ENGLAND)
3:30—4:00	Coffee Break
4:00—5:00	Validation of Dissolution Methods Kerstin Pauli (GERMANY)
5:00—6:00	Discussions and Closing Remarks

Chairs and Speakers

Prof. Dr. Dr. h.c. Adel Sakr is Distinguished Chaired Professor of Industrial Pharmacy and Pharmaceutics at the College of Pharmacy, King Saud University, Riyadh, KSA; Emeritus Professor at the University of Cincinnati, USA; academic and international consultant 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. Professor Sakr is an elected Fellow of AAPS and Graduate Fellow of the University of Cincinnati. He is the recipient of the Distinguished Faculty Achievement Award of the University of Cincinnati. Prof. Sakr is Emeritus Congress Chair, FIP-Industrial Pharmacy Section and is the recipient of the 2008 AAPS Outstanding Pharmacy Educator Award.

Dr. Gabriele Betz was the interim Chair in Pharmaceutical Technology, University of Basel, Switzerland for 4 years and is heading the Industrial Pharmacy Research Group. She advises more than 11 Ph.D. candidates, co-authored more than 30 publications and 100 conference presentations. She is the recipient of the NETS 2004, SHARE 2004 and FIP-IPS 2008 awards. She is a member of the “REGENZ” of University of Basel and a visiting professor to Future University, Egypt.

Engineer Dale Natoli, Vice President of Natoli Engineering Company, Inc., has over 32 years troubleshooting in the tablet compression industry. Natoli has published articles for major pharmaceutical publications and authored chapters in three books, including the “Tablet Specification Manual”, sponsored by the American Pharmaceutical Association. He presents lectures for universities, pharmaceutical associations and tablet manufacturers worldwide.

Engineer Doug Kirsch is the Technical Service Manager for the tablet press division at Natoli Engineering Company, Inc. With over 40 years of experience in the tablet compression industry, he has been with Natoli for over 28 years and has trained press operators and maintenance technicians worldwide. He began his career training in the U.K. with Manesty machines and then served as a Technical Service Representative for Manesty tablet presses over 10 years. For the next three years, he served as the Maintenance Manager for tablet compression at General Nutrition Corporation.

Gregory Thoorens, M.S. is a Senior Scientist at FMC BioPolymer, European Technical Center. Gregory graduated as Industrial Engineer with a specialization in biochemistry. During his thesis at Cargill, he characterized several excipients using an instrumented tablet press. The Belgian Royal Society of Chemistry awarded him a prize for the best Industrial Engineer thesis. Gregory also obtained a Master Degree in Pharmaceutical Engineering from UCL, Brussels.

 

 

Engineer Jeff Hoskinson is the Product Manager for Fluid Bed and High Shear Granulation Systems at Vector Corporation. His responsibilities include equipment configuration oversight and sales support. Jeff attained his Bachelor’s Degree in Mechanical Engineering from Iowa State University and his Master’s Degree in Business Administration from the University of Iowa.

Dr. John Tillotson is Applications Lead and a Senior Scientist in the R&D department at SPI Pharma. He has developed multiple orally dispersing tablet and powder technologies and formulations. Dr. Tillotson received his Ph.D. in Industrial Pharmacy from the University of Cincinnati (USA).

Dr. Ehab Hamed is Associate Director of R&D at CIMA LABS, a Cephalon Company. In this role, Dr. Hamed has successfully developed several orally disintegrating tablets products. He also led the efforts to develop new drug delivery platform that affords tampering deterrent attributes for drug of abuse. He holds a Ph.D. in Industrial Pharmacy from the University of Cincinnati, USA.

Dr. Mohamed Abbas Ibrahim is an assistant professor of Pharmaceutics, Kayyali Chair for Pharmaceutical Industries, King Saud University, KSA. He gained a Ph.D. in Pharmaceutical Technology from the University of Regensburg, Germany, in collaboration with Al-Azhar University. His research interests include biomaterials such as drug delivery systems and industrial pharmacy and he has published several international research articles in these areas.

Prof. Dr. Roland Bodmeier is Professor of Pharmaceutical Technology at the College of Pharmacy at the Freie Universität Berlin in Germany. Earlier, he served as an Associate Professor at the College of Pharmacy at the University of Texas at Austin, USA. His research focuses on innovative drug delivery systems with controlled drug release (peroral systems, biodegradable implants/microparticles, microencapsulation, multiparticulate dosage forms) and has resulted in more than 150 publications, book chapters and patents/-applications.

Bruno Leclercq is a pharmacist with experience gained at Reckitt & Colman (UK) in pharmaceutical solid dosage form development, at Thissen Laboratories in production of solid dosage forms and at Cerestar (starch and polyols manufacturer) in new product development. In his current position, he is responsible for global technical support and for the new products development of FMC BioPolymer pharmaceutical excipients.

Engineer Fadhel Belaiba is the regional commercial director at Harro Höfliger, his tasks consist of understanding the customer requirements and providing them with an individual solution during all phases, from process development, machine development & building, stability samples to product launch. He studied Business and Technical Engineering at the University of Cologne.

Dr. Karlheinz Seyfang is Division Leader Pharma Services, Harro Höfliger Verpackungsmaschinen GmbH, Germany. Ηe is expert Solid Dose production, Galenical development, Powder dosing and handling and Pulmonary Drug Delivery. He obtained his Master of Pharmaceutical Sciences and Doctor of Natural Science from the University of Wuerzburg.

Erik Naeser, M. Pharm. Sci., MBA, is a Swedish pharmacist having many years of experience in the pharmaceutical industry focusing on Quality Assurance. Nowadays Mr. Naeser works as an entrepreneur within the health care segment and also acts as a board member within the International Pharmaceutical Federation’s Industrial Pharmacy Section.

Prof. Dr. Sandra Klein is Professor of Pharmaceutical Technology at the Ernst-Moritz-Arndt-University in Greifswald, Germany. Her research is focussed on developing biorelevant in vitro models to predict drug bioavailability from oral and vaginal delivery systems and on improving the bioavailability of poorly soluble drugs. She is co-author of various original manuscripts and book chapters and has been an invited speaker at international dissolution workshops of AAPS, APV, CRS, FIP and WHO amongst others.

Dr. Kerstin Pauli is head of Dissolution Testing in Global Drug Development, Bayer Schering Pharma, Berlin, Germany. She is responsible for all aspects regarding dissolution testing of development projects including development and validation of dissolution methods, submission of development projects and handling of post approval changes, life cycle management and patent protection of market products and also for automation in dissolution testing (Robot Technology).

Dr. Horst-Dieter Friedel is head of a department in Global Quality Assurance for Pharma Drug Products and Active Pharmaceutical Ingredients, Bayer Schering Pharma, Berlin, Germany. He spent 15 years in the quality control for pharmaceutical drug products under development. He graduated in pharmacy and chemistry in Marburg, Germany and received his Ph.D. in pharmaceutical chemistry. He is co-chair of the FIP special interest group on Dissolution/Drug Release.

Dr. Nikoletta Fotaki is a Lecturer in Pharmaceutics at the University of Bath, UK. She participated in several research projects in the School of Pharmacy of the National and Kapodistrian University of Athens and in Hoffman La Roche. Her expertise is on drug absorption, biorelevant dissolution methods, biowaivers, in silico models, in vitro-in vivo correlations, formulation development, and animal models for the prediction of absorption.