Department
Dermatopharmacology
Annual Report 1999/2000
of
the Department Dermatopharmalogy in the Gesellschaft für Dermopharmazie e.V. (Society
for Dermopharmacy), reporting period June 1999 to May 2000
Members
The number of members has increased by 1 member from industry to 24.
As before, however, the majority of members comes from the field of academia.
Unfortunately, there is no member from the field of the public pharmacy up to
date.
The
following two department activities took place last year
1)
Coorganization of the two-day event's first part ‚The skin as a biological
barrier' of the ‚Third International Course and Workshop on Cell Culture and Other
Alternative Methods for Drug Delivery Research' of the department Biopharmacy
and Pharmaceutical Technology at the University of the Saarland. The course took
place in Saarbruecken from 23 February to 3 March 2000. 44 international speakers
have cooperated in this international course and more than 100 participants from
all over Europe but also from Asia, the United States and Middle East have participated.
This event's aim was to serve as platform for disucussion between experienced
scientists of the respective fields, doctorands, representatives of industry and
public authorities. Furthermore, there was a possibility to get acquainted with
the various analysis techniques for dermatologically applied drug forms in a practical
laboratory course of the part ‚The skin as a biological barrier'. Professor Richard
Guy (CH-Geneva) has undertaken to give an overview and introduction about the
skin as barrier. Professor Veronique Préat (B-Brussels) reported about the latest
status of the ‚electro-assisted delivery systems'. Different in-vitro test systems
as the cow udder model (BUS) (Professor Kiezmann, D-Hanover), models with excised
human skin (H. Wagner, D-Saarbruecken) and egg choriantallois membrane (Dr.Kunzi-Rapp,
D-Ulm) have been presented. The possibilities of application of reconstructed
skin equivalents have been explained by professor M. Fartasch (D-Erlangen), Dr.
M. Liebsch (phototoxicity; D-Berlin) and Dr. C. Wiemann (corrosivity test, D-Ludwigshafen).
About liberation processes, in-vivo methods, pharmacokinetic and pharmacodynamic
aspects, microdialysis and regulatory requirements reported Dr. P. Loos (D-Frankfurt),
Dr. B. Gabard (CH-Egerkingen), professor M. Fartasch (D-Erlangen), Dr. C. Leopold
(D-Duesseldorf) and Dr. S. Reiter (BfArM, D-Berlin). The following subjects have
been dealt with during a practical laboratory course: a) Franz-cell-technique,
b) a penetration model for the determination of drug-concentration-skin-depth
profiles developed in Saarbrueck, c) drug liberation from ointments in-vitro,
d) application of confocal laser scanning microscopy for the visualization of
transport processes in skin. In the second part of the course, additional barriers
as nasal, blood-air-barrier (pulmonal), gastro-enteric-tract-barrier and blood-brain-barrier,
the application possibility of computer simulation for the assessment of invasion,
epithelal permeability but also for the development of drug delivery systems,
various visualization and analytical methods as well as regulatory aspects have
been put up for discussion.
2) Establishing
of a ‚call for tenders text' for the collection of dermatopharmacological methods
which is to serve as basis for the editing of a catalogue for examined dermatopharmacological
methods. This text will be added to the GD homepage within the days to come.
Outlook/additional
activities
It has been planned to set up a virtual
discussion forum, i.e. department members can jointly discuss problematic issues
and formulations of questions via Internet (e-mail-exchange between the group
members) in the next year. We expect from this exchange an increase of departmental
activities, an improved information exchange and a stimulation of discussion.
(reported by Dr. Ulrich Schäfer)
Third International Intensive Course and Workshop on Cell Culture and Other Alternative Methods for Drug Delivery Research
Department of Biopharmaceutics and Pharmaceutical Technology, Saarland University, Saarbrücken/Germany , 23rd February till 3rd March 2000.
For the third time this international 10-days course was held at Saarland University, organized by Prof. Dr. Claus-Michael Lehr and Dr. Ulrich Schäfer. It was financially supported by the EU-program SOCRATES (former IC 9-71 ERASMUS) as a part of the European Network GALENOS’ ongoing European Masters Program for Advanced Drug Delivery Research. APV (international Association for Pharmaceutical Technology), CRS (Controlled Release Society, Germany local chapter), DPhG (German Pharmaceutical Society), the German Society for Dermopharmacy (GD) and EUFEPS (European Federation for Pharmaceutical Sciences) acted as sponsors. The workshop featured presentations and discussions together with a practical lab courses and a poster session. The course was attended by 44 speakers and more than 100 participants for the largest part from Europe, but also from overseas (USA, Middle East and Asia).
Major aim of the course was to create a platform
for both the scientific discussion between experts, as well as to provide relevant
basic information for graduate students and novices to this field, either working
in academia or in the pharmaceutical industry. Hence, it was structured to bring
together post graduate students, academics, industrialists as well as regulators.
The
skin as a biological barrier
The program of the workshop was basically structured into two major sections; the first two days (24th. and 25th. February) dealt with the skin as a biological barrier and it began with lectures from Prof. Richard Guy (CH-Geneva), on the fundamentals of this barrier, and on electro-assisted delivery systems presented by Prof. Veronique Preat ( B-Brussels). The different in vitro test models (cow udder, excised human skin and egg chorioallantois membrane) were firstly approached in the second session(Prof. Kiezmann D-Hannover; H. Wagner, D-Saarbrücken; Dr. Kunzi-Rapp, D-Ulm) followed by test models based on reconstructed skin (Prof. M Fartasch, D. Erlangen), Phototoxicity (Dr. M Liebsch, ZEBET, D-Berlin) and skin corrosivity issues (Dr. C. Wiemann, D-Ludwigshafen). In another separate session, in vivo test methods, including pharmacokinetic and pharmacodynamic assessments, microdialysis together with some regulatory aspects were addressed by Dr P. Loos (D-Frankfurt), Dr. B Gabard (CH-Egerkingen), Prof. M. Fartasch ( D-Erlangen), Dr. C. Leopold (D-Düsseldorf) and Dr. S. Reiter (BfArM, D- Berlin).
The seminars of this first part were followed by a laboratory course with practical demonstrations covering the following topics: 1) Franz diffusion cell, 2) Saarbruecken skin penetration model, 3) Drug liberation from ointments in vitro, and 4) Confocal laser scanning microscopy as a functional imaging tool for the evaluation of drug penetration. The participants were divided into four groups each with a maximum number of 10 and they had the opportunity to see the preparation of excised human skin for drug penetration studies as well as its introduction into the different test permeation models, sampling, and basic data analysis. The practical part was supervised by Dr. U. F. Schaefer (Saarland University), Dr. C. Leopold (Heinrich Heine University/ Duesseldorf) as well as the Ph.D. students in the department.
Mucosal and other barriers
The second part of the course
(28th. Feb.-3rd. March) was dedicated to the different mucosal barriers for drug
delivery and was divided into six subsections.
The regulatory aspects were introduced first,
which focused on the standardization and validation of in vitro test models as
alternative methods to animal studies (Prof. Spielmann, ZEBET,-D- Berlin) patent
licensing issues of cell culture systems (M. Grund, D-Munich) and the FDA guidance
for industry on waiver of in vivo bioavailability and bioequivalence testing (Dr
Lawrence Yu, FDA, USA-Wahington; Prof. H. Blume, D-Frankfurt). The biological
barriers of the GI tract were discussed into two session, encompassing at one
end monitoring of GI transit (Prof W. Weitschies, D- Greifswald) gut wall metabolism
and proteins (Prof. U. Fuhr, D-Köln; Prof. H. Kroemer, D-Greifswald) validation
of epithelial cell cultures for drug transport studies (Dr. E, Haltner, D-Saarbrücken;
Dr. W. Rubas, USA-San Francisco) vesicular trafficking in epithelial cells (Prof.
C. Okamoto, USA-Los Angeles) and bioelectrical characterization of epithelial
tissues (Prof. K.J. Kim, USA-Los Angeles). At the other end physiological dissolution
testing (Prof. J Dressman, D-Frankfurt), Ussing chamber (Prof. J. Tucker, NL-Utrecht),
intestinal perfusion techniques (Dr. Th Grammatte, D-Dresden) and secretory carriers
affecting intestinal permeability and drug absorption (Prof. P. Langguth, D-Mainz)
were covered.
In another session, the emphasis was moved to nasal and pulmonary drug delivery, and a profound description of the available and newly characterized in vitro test models such as those for nasal drug absorption, upper and lower airway epithelium together with some drug delivery applications (Prof. H.P. Merkle, Ch-Zurich; Dr. G. Borchardt, NL-Leiden; Dr. M. Gumbelton,UK-Cardiff, Dr. D. Edwards, USA-Cambridge) . The blood brain barrier issue was touched through two lectures (Prof. H. Galla, D-Münster; Prof. G. Fricker, D-Heidelberg) dealing with in vitro cell culture models and enhancement of the transport of drugs through this barrier.
Computational methods for the estimating rate and extent of absorption, transmembrane modeling, epithelial permeability as well as molecular simulation for drug delivery were approached in a separate session by Prof.M. Bolger, USA-Los Angeles; Prof. I. Harworth, USA-Los Angeles; Dr. K Palm, S-Göteborg; Dr. M. Story, Australia; and Dr. A. Bick, UK.
The closing session was dedicated to visualization and analytical tools, including fluorescence correlation spectroscopy (Dr. H. Häberlein,D-Marburg), modern scanning probe techniques (Prof. U. Hartmann, D-Saarbrücken), scanning force microscopy (Dr. U. Bakowsky, NL-Groningen) cryo-electron microscopy (Dr. R. Wepf, D-Hamburg) and surface plasmon resonance spectroscopy (Dr. Struss, D-Frankfurt).
Very much as the first section, the second one was followed by a practical course, in which the participants came into closer contact with live tissue culture systems and had the opportunity to do some classical cell binding assays, transport experiments, ion transport and bioelectrical characterization of epithelial cells and a demonstration for the use of atomic force microscopy as a visualization technique for drug receptor interaction. The studies were mostly carried out Caco-2 cells. The second Lab-course was supervised by Prof. J. J. Tukker (Utrecht), Prof. M. Wirth (Vienna), Prof. K. J. Kim (Los Angeles-USA) and Prof. U. Hartmann (Saarland University) together with the assistance of post graduate students of the Department of Biopharmaceutics and Pharmaceutical Technology of Saarland University.
Poster session and Social Program
Over 30 poster presentations were displayed throughout the entire workshop and Saturday (26th February) was assigned as “Students day“, in which students had the opportunity to hold a short communication about their posters and present it to the others. The session provided an excellent forum where the students and established researchers could exchange ideas and opinions.
The social program of the course was an opportunity for the participants to experience and enjoy the German hospitality and to see some touristic attractions of the Saarland. On Sunday, all participants were invited to a day trip to the Saarschleife and to visit the Old Steelworks in Völklingen, an impressive heritage of a former industrial era, which nowadays enjoys the status of a World Cultural Monument by UNESCO. The President of Saarland University arranged for a reception party, and the Minister of Science and Culture personally welcomed the participants from all over the world and emphasized his readiness to support such gatherings again in the future. The congress dinner was served in a pleasant atmosphere and provided the participants with a good opportunity for personal contacts.