seminars - APV

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.