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<strong>seminars</strong> 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 <strong>APV</strong> 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.
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