Unit:
Κατεύθυνση Χημική Ανάλυση-Έλεγχος ΠοιότηταςLibrary of the School of Science
Supervisors info:
Νικόλαος Θωμαΐδης, Καθηγητής, Τμήμα Χημείας, Εθνικό και Καποδιστριακό Πανεπιστήμιο Αθηνών
Αναστάσιος Οικονόμου, Καθηγητής, Τμήμα Χημείας, Εθνικό και Καποδιστριακό Πανεπιστήμιο Αθηνών
Χρήστος Κόκκινος, Επίκουρος Καθηγητής, Τμήμα Χημείας, Εθνικό και Καποδιστριακό Πανεπιστήμιο Αθηνών
Original Title:
Development and validation of an HPLC-DAD method for the identification and quantitative determination of related substances of Naltrexone in a Long Acting Injectable formulation
Translated title:
Development and validation of an HPLC-DAD method for the identification and quantitative determination of related substances of Naltrexone in a Long Acting Injectable formulation
Summary:
Generic drugs is a rapidly growing sector in the last decades worldwide. In the first chapter of the theoretical part of this thesis, the meaning of generics is elucidated and a historical overview is presented, firstly. Then, generic drugs are examined from the financial and the regulatory point of view and the term of Bioequivalence, which is essential for generic drugs, is analyzed. Entering the second chapter, the drug delivery system categories are presented. The category of Long Acting delivery depots is highlighted and especially the Long Acting Injectable Microparticles and their manufacturing techniques. A special focus is given on the solvent extraction and evaporation technique, which is also the technique that is followed for the manufacturing of the brand-name drug, Vivitrol, and for the generic one that was utilized for the experimental part of the thesis.
In the experimental part, the development and the validation of an analytical method for the identification and the quantitation of the related substances of Naltrexone in Long Acting Injectable microparticles is presented. The method was proved to be fit for its purpose. Furthermore, a forced degradation study was conducted to determine the degradation profile of the impurities. 2.2 Bisnaltrexone, 10-Keto Naltrexone, Noroxymorphone and twelve unknown impurities exceeded the qualification threshold in some of the tested conditions.
Concluding, the results presented in this thesis highlight the importance of developing suitable analytical methods for the related substances determination since such methods belong to the key analytical methods for the understanding and development of the appropriate formulation.
Main subject category:
Science
Other subject categories:
Chemistry
Keywords:
Long acting injectables, Naltrexone, microparticles, related substances quantitation, HPLC-PDA
File:
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Master thesis third printout mirror margins.pdf
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File access is restricted only to the intranet of UoA.
