CONTINUING EDUCATION COURSES IN INDUSTRIAL PHARMACEUTICAL SCIENCE AND PRACTICE

EUROPEAN CONTINUING
EDUCATION COLLEGE

COURSES FOR 2006

PHARMACEUTICAL GRANULATION AND COMPRESSION

A 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

30^th, 31^st January and 1^st February 2006, Kensington Park Hotel,London, U.K.

COURSE BACKGROUND

Granulation and compression are two very important processes that are carried out extensively by most pharmaceutical companies. However, the theory of granulationis little understood and the selection of a particular machine and granulation method, is often done o­n the basis of tradition, rather than by using strict scientific or cost-benefit criteria. The basic techniques have changed dramatically in recent years andgranulation for controlled release, extrusion, spheronisation, fluidisation techniques, spray drying, melt extrusion, oral dispersion technology and roller compaction are new technologies that are increasingly being used in modern pharmaceutical production, which exhibit many advantages over previously available techniques. As with granulation, compression is also little understood and why some materials/formulations will compress well whilst others compact with difficulty, is slowly being elucidated. The Course will examine current granulation and compression theory and practice. Emphasis will be made as to how this theory and practice relates to current pharmaceutical development and production, with special reference to the machinery used. Scale-Up, Transfer Technology and SUPAC will also be addressed. A particular feature of the Course will be the workshop o­n new melt extrusion technology.

COURSE OBJECTIVES

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 havebeen 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:

1.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.

2.An understanding of the techniques and processes available for granulation in relation to controlled release products.

3.Detailed knowledge o­n current ideas and thoughts o­n Scale-Up, Transfer Technology and SUPAC.

4.An appreciation of some of the compression problems that can arise and how they can be overcome.

5.A knowledge of the factors that should be taken into consideration whenselecting granulation and

            compression equipment.

6. Specialist knowledge o­n fluid-bed granulation, roller compaction, layering, spray drying, oral

            dispersion technology and melt extrusion.

7. Detailed knowledge o­n compression machinery.

8.An appreciation of the techniques available and their limitations for end-point granulation control.

9.A knowledge of the reasons why problems arise in the granulation and compression processes and

            how these problems can be avoided.

WHO SHOULD ATTEND

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.

COURSE OUTLINE

METHODS AND REASONS FOR GRANULATING

Overview of granulation and compression. Techniques available. Theory of granulation.

EXCIPIENTS

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.

LAYERING

Solution, suspension and dry powder layering.

SPRAY DRYING

F.S.D. Spray Drying

PELLET MANUFACTURE

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

ROLLER COMPACTION

Review of the current state of roller compaction. Equipment available. Advantages and disadvantages.

COMPRESSION THEORY

Review. Why some materials compress satisfactorily whilst others compact poorly. Theory related to practice

COMPRESSION MACHINERY

Review of the current state of press design. Removable turrets and cleaning of presses

COMPACTION SIMULATORS

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

WORKSHOP

A workshop will be arranged o­n hot melt extrusion processes.

LECTURERS

MICHAEL H. RUBINSTEINB.Pharm., Ph.D., M.R.Pharm.S., M.I.Chem.E., C.Eng., Q.P. (Course Director)

Professor Rubinstein is C.E.O of Quay Pharmaceuticals Ltd., a contract pharmaceutical R & D and Clinical Trials Manufacturing company o­n the Wirral. 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.

TERRY LEWIS

Mr Lewis is Operations Manager Casburt, U.K. His is accountable for all technical activities of the company and has 28 years expertise in compression and tooling problems.

HARALD STAHL Ph.D.

Dr Stahl is Senior Pharmaceutical Technologist with Niro Pharma Systems with world-wide process responsibility for the technologies supplied by Niro Pharma Systems. Previously he worked in the Pharmaceutical Development Division of Schering AG in Germany.

JAN VOGELEER B.Sc.

Mr Vogeleer is Manging Director of Courtoy N.V., manufacturers of tablet presses in Belgium. He has pioneered the design of new tablet machinery to enable tablets to be produced at faster speeds with minimal clean and down time and has a huge wealth of experience in novel design of compression machinery.

IAN MUIR BSc., Ph.D.

Dr Muir is Vice-President of Zydis at Cardinal Health in the U.K. He is responsible for product development for the fast dissolve Zydis technology. He has had previous experience in various aspects of product development from early compound selection to scale-up and commercialization.

GORDON PRUDHOEBSc

Mr Prudhoe is Quality Assurance Technical Group Manager for Sanofi-Sythelabo. His responsibilities include technical support for production and co-ordination, planning and execution of all transfer activities both in and out of Sanofi-Sythelabo plants worldwide. Mr Prudhoe was previously Manager in charge of the formulation and analytical groups and has developed over 50 generic products. Mr Prudhoe has worked in the industry for over 20 years in a development/production support role.

MARINA LEVINA MSc., Ph.D.

Dr Levina is Global Technical Manager, Excipients at Colorcon Ltd. and is responsible for all technical aspects of the range of Colorcon excipients. She has experience in the production of tablets by conventional and by ultrasound assisted compaction and with the development of solid oral dose formulations for both immediate release and sustained release applications

ABOUT THE COLLEGE

The European Continuing Education College, is now well established worldwide as the leading provider of up-to-date, pragmatically orientated, relevant short courses for Managers, Scientists, Engineers and Technicians. The College specialises in Courses for the pharmaceutical, biotechnology and healthcare industries. These courses are tailor-made to the requirements of the industry and as a result provide information of tremendous benefit to those who may not necessarily be at the forefront of knowledge in a particular area. Over the years our pharmaceutical courses, under the Direction of Professor Mike Rubinstein, have proved extremely popular and are often heavily oversubscribed. This success is mainly due to the very careful selection of material and lectures for the Courses, to the provision of workshops, clinics, case studies and discussion sessions, to the very extensive course notes provided and to small group participation.

Presenters are very carefully chosen from academia and the industry who are both experts and accomplished teachers and great care is taken to ensure that the Courses are right up-to-date and that there is proper integration of both the theoretical and practical considerations of the subject. All material is reviewed and assessed to make sure it is pertinent and relevant. Demonstrations, Case Studies and Workshops of actual pharmaceutical equipment, processes and methods are general features of most of the College courses. In addition most of our courses include problem solving sessions and recently the College has introduced E.C.E.C. Technical Clinics. Participants o­n our courses can let us know beforehand or bring with them, a particular problem or problems pertinent to the subject area of the course, which they would like advice about. This advice will be given either confidentially or more usually at a special open discussion session during the course, at which other participants can offer their advice and experience as well.

The E.C.E.C.also provides tailor-made ‘in-house’ courses for Pharmaceutical, Biotechnology and Healthcare companies.

If you would like further details of our forthcoming Courses, please ask our Office to put you o­n our mailing list. If you require details of our ‘in house’ course service, please contact our Office for more information.

FEES AND REGISTRATION

The participation fee is £1115.00 (exclusive of VAT). Places are strictly limited and therefore applications will be accepted o­n a first come basis. Under UK law all applications are subject to Value Added Tax (VAT) irrespective of the country of origin of participants. Most VAT registered companies/organisations can reclaim this tax. The fee includes full personal participation, extensive bound course notes, luncheons and light refreshments, o­n all days of the Course. Dinner at night is not included. Cancellations cannot be accepted less than 14 days prior to the start of the Course, but substitutions may be made at any time. The Course language will be English. An approved Certificate of Attendance will be given to each participant at the end of the Course.

TIMING OF THE COURSE

Registration will be at 8.45am o­n Monday 30^th January and the Course will commence promptly at 9.00am. The Course will finish at about 17.00 o­n Wednesday 1^st February. The Course will end at about 19.00 o­n each of the first two days.

‘E.C.E.C. TECHNICAL CLINIC’

The College recognises that participants may have a particular problem or problems that they would like advice about. o­n this course participants are invited to send in beforehand (or bring with them) details of their technical problems, which will be considered by the lecturers. A special open discussion session has been timetabled o­n this course at which participants’ problems will be discussed and advice given. At this session other course participants can offer their advice and experiences as well. If you would like advice to be given confidentially, please advise the College beforehand.

ACCOMMODATION

A special room rate of £138.00 (normal rate £190.00) per night single with bathroom, inclusive of breakfast (£172.00 twin/double (normal rate £207.00)), exclusive of VAT, has been negotiated for participants o­n this Course at the superb 4 star luxury Kensington Park Hotel in fashionable Kensington. The Hotel is opposite Kensington Palace and is peacefully situated in De Vere Gardens, just off Kensington High Street. The Hotel is close to Hyde Park, the stylish shops of Knightsbridge (Harrods) and Kensington and the Royal Albert Hall. The West End, Buckingham Palace, Piccadilly Circus, Trafalgar Square and the Houses of Parliament, in fact almost every major attraction, is within easy reach. Nightlife is no problem with cinemas, restaurants, clubs and theatres all in the vicinity. The Hotel has numerous restaurants and bars. High Street Kensington Underground Station is a couple of minutes walk from the Hotel.

DIRECTIONS

BY AIR: From Heathrow Airport the ‘Heathrow Express’ should be taken to Paddington Station. This express train service operates every 15 minutes and the journey time is 15 minutes. o­nce at Paddington Station in central London a short taxi ride can be taken to the Kensington Park Hotel off Kensington High Street. Alternatively the underground ‘tube’ can be taken from Paddington directly to High Street Kensington (4 stops o­n the Circle or District line). o­nce at High Street Kensington Underground Station the Hotel is a couple of minutes walk away. From Gatwick Airport take the train to Victoria and then either a taxi or the Underground (Circle or District Lines) 4 stops, directly to High Street Kensington.

BY TRAIN: All the main line stations connect with the London Underground and participants can get the Underground to High Street Kensington.

BY ROAD: Car parking facilities in Young Street are available nearby but it is expensive.

HOW TO REGISTER-

To register please complete the registration form and forward with your payment to the:

EUROPEAN CONTINUING EDUCATION COLLEGE

24 Menlove Gardens North,

Liverpool L18 2EJ, U.K.

Telephone:+44 (0)151 737 1993 Fax: +44 (0) 151 737 1070

E-MAIL: REGISTER@ECEC.CO.UKWEBSITE: WWW.ECEC.CO.UK

All applications will be acknowledged and a formal V.A.T. receiptissued. Telephone reservations (+44 (0) 151 737 1993) or better Fax (+44 (0) 151 737 1070) or E-Mail (REGISTER@ECEC.CO.UK) to the Courses’ Secretary will be provisionally accepted and confirmed o­n receipt of the form.

REGISTRATION FORM – PHARMACEUTICAL GRANULATION AND COMPRESSION

30^th, 31^st January and 1^st February 2006, The Kensington Park Hotel, Kensington, London, U.K.

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EUROPEAN CONTINUING EDUCATION COLLEGE

24 Menlove Gardens North

Liverpool L18 2EJ, U.K.

Tel: +44 (0) 151 737 1993Fax: +44(0) 151 737 1070

E-Mail: register@ecec.co.uk

www.ecec.co.uk

COURSES 2005/2006

    FOR FURTHER INFORMATION PLEASE CONTACT

Prof Mike Rubinstein

  Tel: +44 151 737 1993Fax: +44 151 737 1070

 E-MAIL: INFO@ECEC.CO.UK

                                                                                                            WWW.ECEC.CO.UK

24 Menlove Gardens North, Liverpool L18 2EJ, U.K.

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