Pharmaceutical Granulation and Compression
Three Day Intensive Course with an Emphasis on High Speed and Fluid Bed Granulation, Layering, Pellet Manufacture, Roller Compaction, Oral Dispersion Technology, Scale-Up, Transfer Technology, Melt Extrusion, Spray Drying and Compression Machinery
The aims of the Course are to provide a comprehensive and sound understanding of the theory and practice of tablet granulation and compression and to appreciate the various processes batch or continuous, that are available. The importance of the granulation process in producing good quality tablets will be emphasised. The modern techniques of extrusion, spheronisation, powder layering, roller compaction, fluid-bed processing, spray drying, melt extrusion, oral dispersion technology and tablet compression will be covered. The Course will be taught primarily by industrial scientists who have been closely involved with investigating these granulation and compression processes and thus a pragmatic approach will be adopted throughout.
Summary of Key Benefits of Attending
At the end of the Course participants will have:
- An understanding of the fundamental principles of granulation and the advantages, disadvantages and potential of the various granulation, layering, spray drying, oral dispersion, extrusion and spheronisation methods
- An understanding of the techniques and processes available for granulation in relation to controlled release products
- Detailed knowledge on current ideas and thoughts on Scale-Up, Transfer Technology and SUPAC
- An appreciation of some of the compression problems that can arise and how they can be overcome
- A knowledge of the factors that should be taken into consideration when selecting granulation and compression equipment
Methods and Reasons for Granulating
- Overview of granulation and compression. Techniques available. Theory of granulation.
- Review of available excipients; advantages and disadvantages. Rationale for selection
Properties of Granules
- Measurement of granule properties. Ideal granule characteristics.
Granulation for Controlled Release
- Review of current methods.
High Speed Granulation and End-Point Control
- Introduction and history. Machine design. Fixed bowl vertical; fixed bowl horizontal. Removable bowl. Operation. Practical experiences. Review of suppliers. Granulation end-point. Diosna probe. Review of techniques of monitoring impellor torque. Slip meter control. Automated control of whole process.
Integrated Mixer-Granulator Dryers
- Review. Advantages and disadvantages. Equipment available.
Fluid Bed Granulation
- Operation. Equipment selection. Fully automated systems. Rotary granulators. Comparison of methods.
- Solution, suspension and dry powder layering.
- F.S.D. Spray Drying
- Techniques available. Spray drying. Drum granulation. Comparison of methods.
Extrusion and Spheronisation
- Extrusion theory. Basic rheological modelling/formulation indicators. Types of extruders. Commercial extruders. Development extruders. Melt Extrusion: Carriers for Melt Extrusion, Solid Dispersions, Examples of Extruders/Other Equipment, Parameters Affecting Melt Extrusion, Formulation and Process Design Problems. Laboratory modelling. Properties of extrudates. Moisture movement across extrudates. The role of microcrystalline cellulose. Spheronisation: spheronisation theory. Commercial equipment. Problems of spheronisation. Evaluation of pellets.
Hot Melt Extrusion
- Review of process. Why hot melt extrusion. Types of solid dispersions. Types of carrier. Equipment. Case study
- Review of the current state of roller compaction. Equipment available. Advantages and disadvantages.
- Review. Why some materials compress satisfactorily whilst others compact poorly. Theory related to practice.
- Review of the current state of press design. Removable turrets and cleaning of presses
- Review and uses
Tabletting and Tooling Problems
- A review of problems that arise in production and how to avoid producing poor quality tablets.
Oral Dispersion Tableting Technology
Review of methods. Advantages and disadvantages of the technology. Equipment required.
Scale-Up, Transfer Technology and Supac
A workshop will be arranged on hot melt extrusion processes.
Prof Michael H. Rubinstein
Geert Verreck M.Eng., Ph.D.
Ian Smales PhD
Paul Burton C.Chem, M.R.S.C.
Harald Stahl Ph.D.
Jan Vogeleer B.Sc.
Ian Muir BSc., Ph.D
Gordon Prudhoe BSc
Marina Levina MSc., Ph.D.
GRANULATION AND COMPRESSION Experts
Michael H. Rubinstein B.Pharm., Ph.D., M.R.Pharm.S., M.I.Chem.E., C.Eng., Q.P. (Course Director) Professor Rubinstein is Chairman and Co-Founder of Quay Pharmaceuticals Ltd., a contract pharmaceutical R & D and Clinical Trials Manufacturing company in North Wales. Previously he was Professor of Pharmaceutical Technology and Director of the School of Pharmacy and Chemistry at Liverpool John Moores University. His research interests include the examination of the granulation process and he has published and lectured widely in the field of tableting technology and the formulation of solid dosage forms. Professor Rubinstein has worked for AstraZeneca and GlaxoSmithKline in production technical support, pharmaceutical development and research. He has published over 200 research papers and articles in the area of solid dosage form technology and in particular in tablet compression. He lead one of the only academic research teams using a high speed Compaction Simulator to fundamentally characterise powder compression. Professor Rubinstein is both a Chemical Engineer and a Pharmacist with Q.P. Status, is the author of 5 books in pharmaceutical technology and two patents and is the series editor of the book series in Pharmaceutical Technology now published by Taylor & Francis Ltd. Professor Rubinstein is a consultant to a number of pharmaceutical companies and governments and is the Conference Co-Ordinator for the annual Pharmaceutical Technology Conferences.
Geert Verreck M.Eng., Ph.D.
Dr Verreck is a Scientist in the Pharmaceutical Sciences Department of Johnson and Johnson in Belgium. He is responsible for the evaluation of the solid dispersion approach for new active compounds, including hot melt extrusion and solubility techniques. He has published 37 papers and is the author of 6 patents in this area.
Ian Smales B.Sc.
Mr Smales is an Associate Scientist at Pfizer Central Research and has responsibilities for optimization, scale-up and technology transfer of pharmaceutical products. He has specialist expertise in wet and dry granulation and in particular roller compaction.
Paul Burton C.Chem, M.R.S.C.
Mr Burton has had extensive experience as a Formulation and Process Development Scientist with Beecham Products, Cyanamid UK and SmithKline Beecham Pharmaceuticals. He has been involved in new product introduction, scale-up of solid dosage forms and process validation. Currently he is Process Technology Manager for Glatt Protech where he has responsibility for applications of fluidised bed technology, high shear granulation and tablet coating technologies.
Mr Lewis is an independent Consultant and was formerly Operations Manager at I.Holland Ltd., UK. His is accountable for all technical activities of the company and has 28 years expertise in compression and tooling problems.
Marina Levina MSc., Ph.D.
Dr Levina is a Lead Product Owner, OSD at GlaxoSmithKline responsible for Global Supply Oncology products. Previously, she worked as a Global Technical Manager, Excipients and Modified Release at Colorcon Ltd. Dr Levina has experience in the production of tablets by conventional and by ultrasound assisted compaction and with the development of various solid oral dose formulations for both immediate release and modified release applications. She has published over 70 research papers and communications in the area of Pharmaceutical Technology, including book chapters, peer-reviewed articles and poster abstracts presented at more than 20 national and international conferences and seminars. She is an Editorial Advisory Board member and reviewer for international pharmaceutical journals.
All who are working in pharmaceutical research, formulation, development, production, QA/QC and registration who require a sound understanding of the various granulation and compression methods and who wish to appreciate some of the advantages of the newer methods of granulation, spheronisation, roller compaction, layering, melt extrusion and compression that are now available.
Great overview of different methods and their advantages/disadvantages’
I wanted to know/hear more about some granulaton/compression
processes, that was achieved in this course’
‘Very relevant lectures/discussions. Good presenters’