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 (ah@apv-mainz.de) 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

Location Austria Trend Hotel Congress

Innsbruck

Rennweg 12a

6020 Innsbruck, AustriaPhone: +43 512 2115Fax: +43 512 2115-550

I herewith repealable authoriseAPV to use my E-mail address tosend me APV relevant materialincluding current programmeinformation. My acceptance canbe cancelled at any time in wri-ting

DateCourse no. 6580from 29 Jan. 2015 09:00to 30 Jan. 2015 13:30

Registration feeAPV member 1160 EURNon-member 1290 EUR(free of VAT according to § 4,22UStG)

Special rate for students with anAPV membership available onrequest.

Coffee breaks, lunch, dinner and proceedings inclu-ded.

RegistrationAPV-GeschäftsstelleKurfürstenstraße 5955118 Mainz/GermanyPhone: +49 6131 9769-0Fax: +49 6131 9769-69e-mail: apv@apv-mainz.de

You will receive a confirmationof your registration with theinvoice.

Members of authorities pay halfof the APV member’s and non-member’s registration feerespectively.

Hotel reservationAustria Trend Hotel Congress

Innsbruck

Rennweg 12a

6020 Innsbruck, AustriaPhone: +43 512 2115Fax: +43 512 2115-550

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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