Masterarbeit

The representation of transdermal systems in the leading pharmacopoeias within the ICH-area and the elaboration of transdermal finished product Monographs ***

Dr. Jutta Keil (2018)

Summary
Language: Englisch
Transdermal Therapeutic Systems (TTS) are one of the oldest and proven pharmaceutical dosage forms. However, they account for a very small market share of <1% and will be prescribed only as niche products compared to the conventional medicinal products. Although TTS offer several significant advantages, the routine administration only became of greater importance in the latter third of the 20th century, when systems with precise and reproducible drug release rates were developed. To date, there are some guidelines on the quality and testing requirements of this dosage form and in 2015, the specific EMA guideline came into force, but the available information in the pharmacopoeias within the ICH area is incomplete and needs urgently to be harmonized.
The aim of this master thesis is to give an overview over the compendial requirements on the quality and analytical testing of transdermal therapeutic systems within the ICH area. The thesis is intended to provide proposals for the harmonization and so to contribute to the efforts of the Pharmacopoeial Discussion Group. Finished product monographs of the USP, BP and JP are presented and evaluated regarding consistency. Finally, a harmonized monograph of Nicotine-TTS and an improved monograph of Buprenorphine-TTS are developed, justified and offered to be ready for submission to the EDQM.
Pages: 65, Annexes: 3, pages: 6