Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory requirements for Transdermal Drug Delivery Systems - A step forward to feasibility and harmonisation?

Anke Müller (Abschlußjahr: 2015)

Summary
Language: English
The aim of this thesis is to provide regulatory guidance on recently arising qualityrelated challenges for registrations of Transdermal Drug Delivery Systems.
Although Transdermal Drug Delivery Systems offer several important advantages compared to "conventional" pharmaceutical dosage forms, they still belong to kind of niche products within the pharmaceutical market.
In the past, only few regulatory documents and hence only little guidance for this special dosage form were available. In the EU, requirements on the development and quality related topics were only briefly covered by the former EMA NfG on modified released products which primarily focussed on the needs for oral dosage forms with modified release characteristics.
Considering the increased number of marketing authorisation applications together with recent scientific developments for transdermal patches, the need for clear guidance on specific requirements for this dosage form increased.
By recently publishing the EMA Guideline on quality of transdermal patches together with the Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms more detailed guidance is now available related to the pharmaceutical development, manufacture, quality control and stability issues of this special dosage form.
The aim of this master thesis is to provide an overview on future quality-related challenges throughout the development and manufacturing of suitable and safe transdermal drug delivery systems. Issues on harmonisation with international requirements other than EU are partly covered where applicable.
The development and application of generic transdermal products will not be subject to this thesis.
Pages: 69