seminars - APV
seminars - APV
seminars - APV
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<strong>seminars</strong><br />
Making<br />
Science<br />
Work<br />
IVIVC<br />
of special dosage forms<br />
12 th to 13 th November, 2008<br />
Mainz, Germany<br />
Course No. 6208<br />
Arbeitsgemeinschaft für Pharmazeutische<br />
Verfahrenstechnik e.V.<br />
Gemeinnütziger wissenschaftlicher Verein<br />
International Association for<br />
Pharmaceutical Technology<br />
Kurfürstenstraße 59<br />
55118 Mainz / Germany<br />
Phone: ++49/6131/9769-0<br />
Fax: ++49/6131/9769-69<br />
e-mail: apv@apv-mainz.de<br />
http://www.apv-mainz.de<br />
Target Group<br />
Scientists from formulation development,<br />
quality control/analytical<br />
method, regulatory departments<br />
and scientists from clinical research<br />
are invited to join the seminar.
<strong>seminars</strong><br />
Programme<br />
Wednesday, 12 th November, 2008<br />
13.00 to 18.00<br />
Welcome address and setting the<br />
scene<br />
Michael Horstmann, PhD<br />
LTS Lohmann Therapie-Systeme AG,<br />
Andernach, Germany<br />
Peter Langguth, PhD<br />
Johannes Gutenberg-University,<br />
Mainz, Germany<br />
Introductory lecture: Definition of<br />
IVIVC, State of the art, limitations,<br />
and guidelines<br />
(De-)Convolution: the body as a<br />
linear system?<br />
Numerical or analytical methods?<br />
Test of IVIVC based on data available<br />
from ordinary equivalence<br />
studies?<br />
How to estimate the in-vivo<br />
absorption and in-vivo release<br />
functions?<br />
Martin Holz, PhD<br />
Statistikberatung Holz, Neuenburg,<br />
Germany<br />
Alternative routes of administration<br />
– The role of a clinical research<br />
institute – Pharmacokinetic peculiarities<br />
Torben Thomsen, MD<br />
Clinical Research Services Andernach<br />
GmbH, Andernach, Germany<br />
Regulatory experience with nonoral<br />
forms: FDA’s perspective<br />
Patrick Marroum, PhD<br />
Food and Drug Administration,<br />
Rockville, United States<br />
Biopharmaceutic considerations in<br />
drug product design and evaluation<br />
Prof. Peter Langguth, PhD<br />
Johannes Gutenberg-University<br />
Mainz, Mainz, Germany<br />
Thursday, 13 th November, 2008<br />
08.30 to 16.00<br />
TTS<br />
Animal tissue models<br />
Thermodynamic and kinetic<br />
impact<br />
Formulation design approaches<br />
Specific performance tests<br />
Michael Horstmann, PhD<br />
Inhalers<br />
Inhaler construction and formulation<br />
approaches<br />
Compendial in vitro models and<br />
alternatives<br />
Impact of inhaler design<br />
Herbert Wachtel, PhD<br />
Boehringer Ingelheim Pharma<br />
GmbH & Co. KG, Ingelheim,<br />
Germany<br />
Injectables<br />
Compendial in vitro models<br />
Real time vs. accelerated tests<br />
Feasibility of biostudies<br />
Stefaan Rossenu<br />
Janssen Pharmaceutica N. V., Beerse,<br />
Belgium<br />
Medicated chewing gums<br />
Spit out method vs. classical BA<br />
approach<br />
Alternatives for compendial<br />
methods<br />
Gajendran Jayachandar, PhD<br />
PHAST GmbH, Biozentrum,<br />
Homburg/Saar, Germany<br />
Implants<br />
Compendial in vitro models<br />
Real time vs. accelerated tests<br />
Feasibility of biostudies<br />
Prof. Karsten Mäder, PhD<br />
Martin-Luther-University Halle-Wittenberg,<br />
Halle, Germany<br />
Regulatory remarks: FDA’s perspective<br />
Compendial in vitro models<br />
Real time vs. accelerated tests<br />
Feasibility of biostudies<br />
Patrick Marroum, PhD<br />
Regulatory remarks: EU perspective<br />
Jobst Limberg, PhD<br />
Jürgen Schomakers<br />
Federal Institute for Drugs and<br />
Medical Devices (BfArM),<br />
Bonn, Germany<br />
Roundtable Discussion<br />
Programme is subject to change
IVIVC of special dosage forms<br />
A seminar organised by the <strong>APV</strong> focus groups<br />
Drug Delivery and Biopharmacy and Pharmacokinetics<br />
Course Leader<br />
Michael Horstmann, PhD is a pharmacist<br />
by profession and extended<br />
his education in pharmacology and<br />
related fields during doctoral studies<br />
at the University of Münster.<br />
He was awarded his PhD for his thesis<br />
on chronic effects of nicotine<br />
delivered via an implanted delivery<br />
system in 1983.<br />
He started his industrial career at<br />
Beiersdorf AG in Hamburg establishing<br />
a laboratory for transdermal<br />
formulation development. Since his<br />
move to LTS Lohmann Therapie-<br />
Systeme AG in 1987 as deputy head<br />
of R&D, he has led and supported<br />
several transdermal and oral film<br />
projects. Since 1999 he was promoted<br />
and now leads the transdermal<br />
and analytical research and development<br />
group at LTS.<br />
Johannes Kraemer, PhD is founder<br />
and managing director of PHAST<br />
laboratories. He is also the Qualified<br />
Person for manufacturing and batch<br />
release. He has been working in the<br />
field of dosage form performance<br />
testing since 1987.<br />
He has obtained his degree in Pharmacy<br />
from Frankfurt University and<br />
his PhD in Pharmaceutical Technology<br />
& Biopharmacy from Heidelberg<br />
University.<br />
With USP, Rockville, Kraemer is elected<br />
member of the Biopharmaceutics<br />
Expert Committee and co-chair<br />
of the Mucosal Drug Delivery Advisory<br />
Panel. In the FIP he is member<br />
of the SIG Dissolution/In Vitro<br />
Release Performance testing. His<br />
scientific interest is focused on<br />
IVIVC-based dissolution method<br />
development for oral pharmaceutical<br />
dosage forms and other formulations<br />
with special regard to stability<br />
problems.<br />
Objectives<br />
IVIVC standards were set for extended<br />
release oral dosage forms by<br />
CDER/FDA in September 1997.<br />
Since the principles of IVIVC are<br />
considered to be similar for non-oral<br />
dosage forms, the guidance for oral<br />
extended release products may be<br />
applied for non-oral products as<br />
well. Despite generally encouraging<br />
comments by scientists and regulators,<br />
there seems to be little application<br />
of these concepts outside of the<br />
oral delivery field. One of the reasons<br />
for this might be differences between<br />
the in vitro release methodology<br />
applied to non-oral and oral extended<br />
release dosage forms, how dissolution<br />
profiles relate to product quality<br />
and the type of specifications set.<br />
Another one may be the notion that<br />
non-oral forms are generally in<br />
contact with a much smaller diffusional<br />
tissue area than that in the<br />
somehow ideal situation of the<br />
intestinal mucosa.<br />
This course will start with an introduction<br />
summarizing current IVIVC<br />
rules, clinical, formulation/processrelated<br />
aspects and regulatory status.<br />
On the second day speakers will<br />
give their opinions on how IVIVC<br />
could be applied to specific non-oral<br />
dosage forms such as transdermals,<br />
inhalers, injectables, implants and<br />
chewing gums. In particular, the<br />
speakers will discuss the established<br />
in vitro dissolution tests, alternative<br />
methods for measuring release and<br />
the feasibility of using these methods<br />
to predict in vivo absorption and its<br />
variability.<br />
Finally, during the roundtable discussion<br />
speakers, organizers (and<br />
participants) will debate and<br />
attempt to develop common guidelines/standards<br />
for the meaningful<br />
in vitro characterisations for special<br />
dosage forms.
Date<br />
Course No. 6208<br />
from 12 th Nov. 2008 13.00<br />
to 13 th Nov. 2008 16.00<br />
Location<br />
Novotel Mainz<br />
Augustusstraße 6<br />
55131 Mainz, Germany<br />
Phone: ++49/6131/954-0<br />
Fax: ++49/6131/954-100<br />
<strong>seminars</strong><br />
Registration<br />
Anmeldung<br />
Seminaranmeldung / Registration<br />
by fax ++49/6131/9769-69<br />
oder per Post an/or by postal service to:<br />
<strong>APV</strong> Arbeitsgemeinschaft für<br />
Pharmazeutische Verfahrenstechnik e.V.<br />
Kurfürstenstraße 59<br />
D-55118 Mainz<br />
Registration fee<br />
<strong>APV</strong> member 1360 EUR<br />
Non-member 1490 EUR<br />
(free of VAT according to<br />
§ 4,22 UStG)<br />
Coffee breaks, lunch, dinner<br />
and proceedings included.<br />
Accounts<br />
Dresdner Bank AG Mainz<br />
Account No. 2 325 159 00<br />
Bank Code 550 800 65<br />
Postbank Frankfurt/M.<br />
Account No. 127 35-606<br />
Bank Code 500 100 60<br />
Veranstaltung/Course No. 6208<br />
Titel/Title: IVIVC of special dosage forms<br />
in Mainz, Germany, from 12 th to 13 th November, 2008<br />
Titel, Vorname, Name<br />
Title, First Name, Name<br />
Firmenname<br />
Company Name<br />
Firmenadresse<br />
Company Address<br />
Telefon Fax<br />
Phone<br />
e-mail Adresse<br />
e-mail Address<br />
Registration<br />
<strong>APV</strong>-Geschäftsstelle<br />
Kurfürstenstraße 59<br />
55118 Mainz, Germany<br />
Phone: ++49/6131/9769-0<br />
Fax: ++49/6131/9769-69<br />
e-mail: apv@apv-mainz.de<br />
You will receive a confirmation<br />
of your registration with the<br />
invoice.<br />
Members of authorities pay<br />
half of the <strong>APV</strong> member’s and<br />
non-member’s registration fee<br />
respectively.<br />
Stellung im Betrieb Abteilung<br />
Position in Company Department<br />
<strong>APV</strong>-Mitglied Nichtmitglied<br />
<strong>APV</strong> Member Non-member<br />
Datum Unterschrift<br />
Date Signature<br />
Hotel reservation<br />
Novotel Mainz<br />
Augustusstraße 6<br />
55131 Mainz, Germany<br />
Phone: ++49/6131/954-0<br />
Fax: ++49/6131/954-100<br />
Participants must make their<br />
own hotel reservation referring<br />
to the <strong>APV</strong> seminar.<br />
Deadline for special conference<br />
rate: 15 th October, 2008.<br />
Special rate: Single room incl.<br />
breakfast buffet EUR 124.00<br />
per night.<br />
Mainz, June 2008