Target Group • Pharmacists and other scientists • Engineers and technicians working on ODx and MBx • Everyone working in: • Pharmaceutical Development • Manufacturing • Regulatory Affairs • Quality Control • Business Development Hot Topics 29 to 30 January 2015 Innsbruck, Austria Course no. 6580 MAKING SCIENCE WORK Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V. Gemeinnütziger wissenschaftlicher Verein International Association for Pharmaceutical Technology ODx and MBx - Orodispersible and Mucoadhesive Buccal Formulations New products, novel technologies and tailored specifications
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ODx and MBx - Orodispersible and Mucoadhesive Buccal ... · Dear colleagues, various orodispersible drug formulations (ODx) and muco-adhesive buccal drug formulations (MBx) have been
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Target Group
• Pharmacists and other scientists• Engineers and technicians working on ODx and MBx • Everyone working in:
• Pharmaceutical Development• Manufacturing• Regulatory Affairs• Quality Control• Business Development
Hot Topics
29 to 30 January 2015
Innsbruck, Austria
Course no. 6580
MAKING SCIENCE WORK
Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V.Gemeinnütziger wissenschaftlicher VereinInternational Association for Pharmaceutical Technology
ODx and MBx - Orodispersible and Mucoadhesive Buccal Formulations New products, novel technologies and tailored specifications
Dear colleagues,
various orodispersible drug formulations (ODx) and muco-adhesive buccal drug formulations (MBx) have been recent-ly introduced into the pharmaceutical market. These inno-vative medicinal products are either based on orodispersibletablets (ODTs), films (ODFs), lyophilisates (ODLs) or granules(ODGs), or on mucoadhesive buccal tablets (MBTs) or films(MBFs). New dosage forms like orodispersible mini-tablets(ODMTs) already appear on the horizon.
The new dosage forms are intended to release the activepharmaceutical ingredient(s) for local action, e.g. cortico-steroids or local anesthetics, or systemic availability byabsorption through the oral mucosa, e.g. antiemetics orand pain killers. Still, there is confusing wording in scientificliterature, pharmacopoeial monographs and the labels ofthe existing products.
This seminar will reflect on the recent developments andinnovations in formulation development, manufacturingand quality control, biopharmaceutical methods for charac-terization and regulatory issues.
We are looking forward to meeting you in Innsbruck, whichcalls itself the “capitol of the Alps”.
Dr. Kathrin BartscherNextPharma Waltrop
Prof. Dr. Jörg BreitkreutzHeinrich-Heine-University
Dr. Michael Horstmanntransdermalpharma UG
Programme
Thursday, 29 January 2015, 09:00 to 18:15 h
Welcome and IntroductionDr. Kathrin BartscherNextPharma Waltrop, Waltrop, GermanyProf. Dr. Jörg BreitkreutzHeinrich-Heine-University, Düsseldorf, GermanyDr. Michael Horstmanntransdermalpharma UG, Neuwied, Germany
Part 1: Definitions and Overview of Orodispersibledosage forms (ODx)
Orodispersible tablets (ODTs), minitablets (ODMTs)and granules (ODGs) – History and current productsDr. Joachim HerrmannDr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany
Oral lyophilisates (melting tablets) – History and current productsLeon Grother Catalent Pharma Solutions, Swindon, United Kingdom
Orodispersible films (ODFs) – History and current productsDr. Armin Breitenbachtesa Labtec GmbH, Langenfeld, Germany
Part 2: Definitions and Overview of MucoadhesiveBuccal Formulations (MBx)
Mucoadhesion and mucoadhesive buccal preparationsProf. Andreas Bernkop-SchnürchUniversity of Innsbruck, Innsbruck, Austria
Mucoadhesive buccal films (MBFs)Mark SchobelMonosol Rx, Portage, IN, United States
Part 3: Processing Technologies and Materials
Formulation development and manufacturing of ODTs Dr. Dieter LubdaMerck Millipore, Darmstadt, Germany
Formulation development and manufacturing of ODFsand MBFsDr. Andreas Krekeler Hexal AG, Holzkirchen, Germany
Hot Topics
API printing technologiesDr. Carole PlanchetteRCPE GmbH, Graz, Austria
Packaging of ODFs and MBFsJohannes JansenOptima life science GmbH, Schwäbisch Hall, Germany
Discussion
Networking dinner
Friday, 30 January 2015, 09:00 - 13:30 h
Part 4: Biopharmaceutical and Clinical Evaluation ofODx and MBx
Drug permeation through oral mucosaProf. Dr. Eva RobleggKarl-Franzens-University, Graz, Austria
Requirements for bioequivalence assessment in case ofODx and conditions for biowaiver applicationsProf. Dr. Henning BlumeSocraTec R&D GmbH, Oberursel, Germany
Part 5: Quality Control and Regulatory Affairs
Pharmacopoeial specifications of ODFs, MBFs andODTs(follow-up of APV seminar in Dortmund 2013)Prof. Dr. Jörg BreitkreutzHeinrich-Heine-University, Düsseldorf, Germany
Analytical testing of ODx and MBxDr. Maren PreisSapiotec GmbH, Würzburg, Germany
Regulatory perspectives on ODx and MBxSpeaker from authority to be confirmed
Discussion, summary and closingDr. Kathrin BartscherProf. Dr. Jörg BreitkreutzDr. Michael Horstmann
Programme is subject to change
Table-top presentations
There is limited space available for table-top presentationsin front of the meeting hall. If you are interested to presentnews and recent products from your company, please askAPV-Office ([email protected]) for further information.
Be quick, as the exhibition was sold out at our previousseminar on ODFs.
How to get to Innsbruck?
Right in the heart of Europe, Innsbruck is very convenientlylocated. A well-developed road and rail network connectsthe Tyrolean capital to the world: A 12 autoroute (toll stik-ker required) leads from East (Munich, Salzburg, Brenner) toWest (Arlberg arena).
Innsbruck may be reached by plane through Innsbruck air-port or Munich airport. Convenient airport shuttles areavailable from both airports. In the winter season, there aremany direct flights to Innsbruck airport, e.g. from Amster-dam, Berlin, Düsseldorf, Eindhoven, Frankfurt, London Gat-wick, Moscow Domodedovo, Rotterdam, or Vienna.
Book early as there are numerous skiing tourist who fly toInnsbruck and move on to the very near, world-famous ski-ing resorts.
ODx and MBx - Orodispersible and Mucoadhesive Buccal Formulations
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Participants should make theirown hotel reservation referringto the APV seminar.
Deadline for special conferencerate: 01 December 2014.
Special rate: Single room incl. breakfast buf-fet from 100 EUR per night.
Mainz, October 2014
Registration by fax +49 6131 9769-69MAKING SCIENCE WORK
RegistrationAs soon as you have found a seminar of your inte-rest, it is very easy to register for it via fax, e-mailor online. We will process your registrationpromptly and certainly are available for any questi-ons that may arise.
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Follow-upAfter the event, we are open to receive any sugge-stions and critique that might arise during theseminar and will certainly help you with furtherquestions you may have.
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Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V.Gemeinnütziger wissenschaftlicher VereinInternational Association for Pharmaceutical Technology