Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Verbesserung der Arzneimittelsicherheit durch Aufnahme in das BtM-Gesetz am Beispiel des Tilidins ***

Mecit Gedik (Abschlußjahr: 2013)

Summary
Language: German
Tilidine is an opioid analgesic that is available for clinical use in combination with naloxone. The combination preparation with the exception of fast release solution is exempt from some of the provisions of the German Narcotic Drugs Act. In recent years reports of abuse and dependence on Tilidin with rapid drug release increased particularly among young people.
In January 2013 tilidine with rapid drug release was placed under the regulation of the German Narcotic Act.  
The master thesis explains why the inclusion of tilidine and naloxone is an improvement of drug safety.
It contains not only the legal aspects of narcotic drugs but also attempts to prevent abuse and dependence of tilidine.  
The fixed combination of tilidine with naloxone stopped the abusive use of tilidine in the seventies. But it also demonstrates why the fixed combination of tilidine and naloxone with rapid drug release can not completely prevent the oral tilidine abuse. The master thesis analyzes the decision of the Committee of Experts on drug narcotics (Sachverständigenausschuss für Betäubungsmittel).
Pages:50, Annexes: pages 4