APV Expert Workshop: The Preformulation Tool Box | CN 6740
The Key to Enter Successful Drug DevelopmentVenue
Best Western Premier IB Hotel Friedberger WarteHomburger Landstraße 4
60389 Frankfur am Main
Phone:+49 69 76 80 64 0
Fax:+49 69 76 80 64 555
Workshop programme for download
Description
Preformulation is the key to successful drug development.
In the preformulation phase, the physicochemical properties of APIs are characterized, potential liabilities are identified, and step by step various formulation approaches are screened and compared in order to turn Active Pharmaceutical Ingredients (APIs) into drugs which progress into (pre-)clinical programs.
This requires a critical set of compound sparing assays that gain information about
- solid state properties (e.g. crystallinity, melting point, hygroscopicity, polymorphism),
- solubility (thermodynamic and respectively kinetic),
- dissolution (intrinsic dissolution and from powder),
- permeability,
- and stability (chemical, physical).
This sound data package is the basis for the rational choice of formulation principles and for (preclinical) formulation development that takes bioavailability, manufacturability, and potential development risks into account.
Formulations considered during thecourse range from conventional to enabling formulations such as solubility- (e.g. cosolvents, cyclodextrins, lipids)), dissolution- (e.g. salts, amorphous solid dispersions), permeabilityenhancing (e.g. Pg-p inhibitors) formulations or formulations stabilizing supersaturated states.
This course covers the “whys” and “hows” of preformulation work and provides guidance for efficient preclinical formulation development.
Target groups
This seminar is aimed at all pharma professionals engaged in the development and evaluation of drug formulations, in particular in early development phase.
Objective
The seminar will cover all aspects of this topic starting from the solid state characteristics of drug substances of significance, the basics for the different formulation principles, guidance as to which principle to choose for which type of API, and recent development in the testing and evaluation of formulations with respect to bioavailability.
Relevant case studies presented by experts in the field will open up the discussion of connected issues in groups. These group discussions may suggest alternative approaches or strategies and add to the profit for each seminar participant.
There is also room to discuss further cases coming from the audience.
Speaker
Prof. Dr. Annette Bauer-Brandl
University of Southern Denmark, Odense M
Approbation; licence as a pharmacist (Germany) Dr.rer.nat; PhD in Pharmaceutics on physics of tableting
post-doc at Wellcome Laboratories, Dartford, UK
post-doc with Novartis, Basle, CH and University of Freiburg
assoc. / full professor at University of Tromsø, Norway
currently: full professor in Pharmaceutics at University of Southern Denmark
Research Interests:
Solid State of matter (API, polymorphism, amorphous materials)
Direct compression of tablets; bilk properties of solid materials; parametrisation of tableting
Solubility and solvation of API molecules
Formulations for poorly soluble drugs, e.g. Solid Phospholipid Nanoparticles SPLN
Dissolution rate and permeation of poorly soluble drugs
Permeapad(R) - th biomimetic permeation barrier
Dr. Christoph Saal
Merck KGaA
Dr. Christoph Saal studied chemistry at the Technical University of Darmstadt with a Ph.D. in Physical Chemistry. Currently he holds a position as Group Leader Molecule Characterization at Merck KGaA.
He is a member of EDQM expert groups for spectroscopic methods and holds a teaching position in Pharmaceutical Technology at the Goethe University Frankfurt.
Registration fee
Price | |
---|---|
Industrie | 1,490.00 € |
Behörde / Hochschule | 745.00 € |
Studenten | 178.00 € |
Organizer(s)
APV-Office
Dr. Martin Bornhöft
Phone: +49 6131 9769-0
Fax: +49 6131 9769-69
E-mail: apv@apv-mainz.de
www: https://www.apv-mainz.de/