Current guidelines and practical experience
Despite an increasing number of approved Transdermal Systems (TDS) commercially available, TDS may still be considered a niche product/route for drug delivery.
Yet TDS remains a valuable drug delivery option with its ability to reach a wider patient profile in an alternative way.
Recently, some important guideline documents on TDS have been created or revised which can provide general guidance in setting up TDS analytics. However, only a comparably small number of companies have hands-on experience in manufacture and testing of TDS, be it in the service sphere or at pharma/biotech companies.
This webinar considers both the main guideline documents as well as practical experience in TDS analytics gained at LTS over the past years.
The webinar will focus on the analysis of drug-in-adhesive (DIA) patches with systemic drug delivery by passive diffusion.
More specifically, this webinar will cover:
- The elements typically found in a TDS specification
- Analytical methods which are:
- (nearly) identical to testing of other dosage forms
- modified compared to other dosage forms
- unique for testing TDS
Presented by
Dr. Michael Komenda,
Corporate Senior Director, Head of Analytical Development R & D
Dr. Michael Komenda has more than 10 years experience in analytical development in the pharmaceutical industry. He studied chemistry at the University of Cologne, Germany, and at the Research Center Jülich, Germany, where he gained his doctorate degree in chemistry. He joined the Pharmaceutical Industry in 2003 and has held various positions in analytical development at SCHWARZ BIOSCIENCES. After the merger with UCB, he became head of analytical development at the German site and lateron head of the Transdermal Center of Expertise within UCB. Since 2012 he is head of Analytical Development at LTS in Andernach, Germany
