Oral Solid Dosage Forms

Transcription

1 ECA E C ACADEMY UROPEAN OMPLIANCE Speakers Erich Battanta Novartis Pharma Dr Urs Flury Pharmaconduct Günter Körblein Senior Advisor in Pharmaceutical Technology Dr Rob Lammens Technical Services Consult Lammens Dr Jean-Denis Mallet Formerly Head of the French Pharmaceutical Inspection Department 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 Oral Solid Dosage Forms Manufacture Technology Compliance Pre-Conference Course Compile your own set of lessons Fundamentals of granulation Fundamentals of tabletting highlights: Barcelona, Spain May 2009 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

2 Objectives Background 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. 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 Moderator Social Event 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. Günter Körblein, Senior Advisor in Pharmaceutical Technology 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. Pre-Conference Course Fundamentals of Tabletting Fundamentals of Granulation 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 Tablet Presses or Basics of Wet Granulation: Fluid bed and High Shear granulators

3 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

4 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 Low Cost Equipment Traditional Equipment Images: Novartis 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.

5 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 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 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 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.

6 Easy Registration Reservation Form: CONCEPT HEIDELBERG P.O. Box Heidelberg Germany Reservation Form: info@concept-heidelberg.de Internet: Date Pre-Conference Course Tuesday, 26 May 2009, h (Registration and coffee h) Date Conference Tuesday, 26 May 2009, h (Registration and coffee h) Wednesday, 27 May 2009, 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 Early reservation is recommended. Venue nh-hotel Constanza C/Deu i Mata, Barcelona, Spain Tel , Fax 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 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 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. If the bill-to-address deviates from the specification to the right, please fill out here: Conference Language The official conference language will be English. Organisation and Contact ECA has entrusted Concept Heidelberg with the organisation of this event. CONCEPT HEIDELBERG P.O. Box Heidelberg, GERMANY Phone +49 (0) 62 21/ Fax +49 (0) 62 21/ info@concept-heidelberg.de For questions regarding content: Dr Robert Eicher (Operations Director) at / or per at eicher@concept-heidelberg.de. For questions regarding reservation, hotel, organisation etc.: Ms Marion Weidemaier (Organisation Manager) at / or per at weidemaier@concept-heidelberg.de. Reservation Form (Please complete in full) Oral Solid Dosage Forms, 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 CONCEPT HEIDELBERG P.O. Box Fax +49 (0) 6221/ Heidelberg Germany Department Important: Please indicate your company s VAT ID Number Street / P.O. Box City Zip Code Purchase Order Number, if applicable Country Phone / Fax (Please fill in) 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 you have not made the payment yet. Only after we have received your payment, you are entitled to participate in the conference (receipt of payment will not be confirmed)! wh/vers.1