seminars - APV

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Making
Science
Work
IVIVC
of special dosage forms
12 th to 13 th November, 2008
Mainz, Germany
Course No. 6208
Arbeitsgemeinschaft für Pharmazeutische
Verfahrenstechnik e.V.
Gemeinnütziger wissenschaftlicher Verein
International Association for
Pharmaceutical Technology
Kurfürstenstraße 59
55118 Mainz / Germany
Phone: ++49/6131/9769-0
Fax: ++49/6131/9769-69
e-mail: apv@apv-mainz.de
http://www.apv-mainz.de
Target Group
Scientists from formulation development,
quality control/analytical
method, regulatory departments
and scientists from clinical research
are invited to join the seminar.

seminars
Programme
Wednesday, 12 th November, 2008
13.00 to 18.00
Welcome address and setting the
scene
Michael Horstmann, PhD
LTS Lohmann Therapie-Systeme AG,
Andernach, Germany
Peter Langguth, PhD
Johannes Gutenberg-University,
Mainz, Germany
Introductory lecture: Definition of
IVIVC, State of the art, limitations,
and guidelines
(De-)Convolution: the body as a
linear system?
Numerical or analytical methods?
Test of IVIVC based on data available
from ordinary equivalence
studies?
How to estimate the in-vivo
absorption and in-vivo release
functions?
Martin Holz, PhD
Statistikberatung Holz, Neuenburg,
Germany
Alternative routes of administration
– The role of a clinical research
institute – Pharmacokinetic peculiarities
Torben Thomsen, MD
Clinical Research Services Andernach
GmbH, Andernach, Germany
Regulatory experience with nonoral
forms: FDA’s perspective
Patrick Marroum, PhD
Food and Drug Administration,
Rockville, United States
Biopharmaceutic considerations in
drug product design and evaluation
Prof. Peter Langguth, PhD
Johannes Gutenberg-University
Mainz, Mainz, Germany
Thursday, 13 th November, 2008
08.30 to 16.00
TTS
Animal tissue models
Thermodynamic and kinetic
impact
Formulation design approaches
Specific performance tests
Michael Horstmann, PhD
Inhalers
Inhaler construction and formulation
approaches
Compendial in vitro models and
alternatives
Impact of inhaler design
Herbert Wachtel, PhD
Boehringer Ingelheim Pharma
GmbH & Co. KG, Ingelheim,
Germany
Injectables
Compendial in vitro models
Real time vs. accelerated tests
Feasibility of biostudies
Stefaan Rossenu
Janssen Pharmaceutica N. V., Beerse,
Belgium
Medicated chewing gums
Spit out method vs. classical BA
approach
Alternatives for compendial
methods
Gajendran Jayachandar, PhD
PHAST GmbH, Biozentrum,
Homburg/Saar, Germany
Implants
Compendial in vitro models
Real time vs. accelerated tests
Feasibility of biostudies
Prof. Karsten Mäder, PhD
Martin-Luther-University Halle-Wittenberg,
Halle, Germany
Regulatory remarks: FDA’s perspective
Compendial in vitro models
Real time vs. accelerated tests
Feasibility of biostudies
Patrick Marroum, PhD
Regulatory remarks: EU perspective
Jobst Limberg, PhD
Jürgen Schomakers
Federal Institute for Drugs and
Medical Devices (BfArM),
Bonn, Germany
Roundtable Discussion
Programme is subject to change

IVIVC of special dosage forms
A seminar organised by the APV focus groups
Drug Delivery and Biopharmacy and Pharmacokinetics
Course Leader
Michael Horstmann, PhD is a pharmacist
by profession and extended
his education in pharmacology and
related fields during doctoral studies
at the University of Münster.
He was awarded his PhD for his thesis
on chronic effects of nicotine
delivered via an implanted delivery
system in 1983.
He started his industrial career at
Beiersdorf AG in Hamburg establishing
a laboratory for transdermal
formulation development. Since his
move to LTS Lohmann Therapie-
Systeme AG in 1987 as deputy head
of R&D, he has led and supported
several transdermal and oral film
projects. Since 1999 he was promoted
and now leads the transdermal
and analytical research and development
group at LTS.
Johannes Kraemer, PhD is founder
and managing director of PHAST
laboratories. He is also the Qualified
Person for manufacturing and batch
release. He has been working in the
field of dosage form performance
testing since 1987.
He has obtained his degree in Pharmacy
from Frankfurt University and
his PhD in Pharmaceutical Technology
& Biopharmacy from Heidelberg
University.
With USP, Rockville, Kraemer is elected
member of the Biopharmaceutics
Expert Committee and co-chair
of the Mucosal Drug Delivery Advisory
Panel. In the FIP he is member
of the SIG Dissolution/In Vitro
Release Performance testing. His
scientific interest is focused on
IVIVC-based dissolution method
development for oral pharmaceutical
dosage forms and other formulations
with special regard to stability
problems.
Objectives
IVIVC standards were set for extended
release oral dosage forms by
CDER/FDA in September 1997.
Since the principles of IVIVC are
considered to be similar for non-oral
dosage forms, the guidance for oral
extended release products may be
applied for non-oral products as
well. Despite generally encouraging
comments by scientists and regulators,
there seems to be little application
of these concepts outside of the
oral delivery field. One of the reasons
for this might be differences between
the in vitro release methodology
applied to non-oral and oral extended
release dosage forms, how dissolution
profiles relate to product quality
and the type of specifications set.
Another one may be the notion that
non-oral forms are generally in
contact with a much smaller diffusional
tissue area than that in the
somehow ideal situation of the
intestinal mucosa.
This course will start with an introduction
summarizing current IVIVC
rules, clinical, formulation/processrelated
aspects and regulatory status.
On the second day speakers will
give their opinions on how IVIVC
could be applied to specific non-oral
dosage forms such as transdermals,
inhalers, injectables, implants and
chewing gums. In particular, the
speakers will discuss the established
in vitro dissolution tests, alternative
methods for measuring release and
the feasibility of using these methods
to predict in vivo absorption and its
variability.
Finally, during the roundtable discussion
speakers, organizers (and
participants) will debate and
attempt to develop common guidelines/standards
for the meaningful
in vitro characterisations for special
dosage forms.

Date
Course No. 6208
from 12 th Nov. 2008 13.00
to 13 th Nov. 2008 16.00
Location
Novotel Mainz
Augustusstraße 6
55131 Mainz, Germany
Phone: ++49/6131/954-0
Fax: ++49/6131/954-100
seminars
Registration
Anmeldung
Seminaranmeldung / Registration
by fax ++49/6131/9769-69
oder per Post an/or by postal service to:
APV Arbeitsgemeinschaft für
Pharmazeutische Verfahrenstechnik e.V.
Kurfürstenstraße 59
D-55118 Mainz
Registration fee
APV member 1360 EUR
Non-member 1490 EUR
(free of VAT according to
§ 4,22 UStG)
Coffee breaks, lunch, dinner
and proceedings included.
Accounts
Dresdner Bank AG Mainz
Account No. 2 325 159 00
Bank Code 550 800 65
Postbank Frankfurt/M.
Account No. 127 35-606
Bank Code 500 100 60
Veranstaltung/Course No. 6208
Titel/Title: IVIVC of special dosage forms
in Mainz, Germany, from 12 th to 13 th November, 2008
Titel, Vorname, Name
Title, First Name, Name
Firmenname
Company Name
Firmenadresse
Company Address
Telefon Fax
Phone
e-mail Adresse
e-mail Address
Registration
APV-Geschäftsstelle
Kurfürstenstraße 59
55118 Mainz, Germany
Phone: ++49/6131/9769-0
Fax: ++49/6131/9769-69
e-mail: apv@apv-mainz.de
You will receive a confirmation
of your registration with the
invoice.
Members of authorities pay
half of the APV member’s and
non-member’s registration fee
respectively.
Stellung im Betrieb Abteilung
Position in Company Department
APV-Mitglied Nichtmitglied
APV Member Non-member
Datum Unterschrift
Date Signature
Hotel reservation
Novotel Mainz
Augustusstraße 6
55131 Mainz, Germany
Phone: ++49/6131/954-0
Fax: ++49/6131/954-100
Participants must make their
own hotel reservation referring
to the APV seminar.
Deadline for special conference
rate: 15 th October, 2008.
Special rate: Single room incl.
breakfast buffet EUR 124.00
per night.
Mainz, June 2008