Generički peptidni lijekovi: metode karakterizacije i procjena istovjetnosti

master's thesis

• Title (english): Generic peptide drugs: characterization methods and sameness evaluation
• Author: Katarina Bernatović
• Mentor: Biserka Cetina Čižmek (mentor)
• Committee member: Biserka Cetina Čižmek (predsjednik povjerenstva)
• Committee member: Jelena Filipović-Grčić (član povjerenstva)
• Committee member: Anita Hafner (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; Zagreb
• Defense date and country: 2020-09-11, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract

Peptidni lijekovi i njihov široki terapijski potencijal postali su dostupniji općoj populaciji
dolaskom generičkih peptidnih lijekova na tržište. Usprkos tome što ne postoje opće
harmonizirane zakonske smjernice za proizvodnju i kontrolu kvalitete peptida, farmaceutska
industrija pod pritiskom je plasiranja generičkih peptidnih lijekova na tržište kako bi se
zadovoljile potrebe liječenja populacije. Kako bi generički lijek dobio odobrenje za stavljanje
na tržište, potrebno je dokazati njegovu istovjetnost s originalnim lijekom, često proizvedenim
različitim proizvodnim procesom. U svrhu ispitivanja istovjetnosti generičkih i originalnih
peptidnih lijekova provode se brojne usporedne analize korištenjem širokog spektra
analitičkih tehnika. Potrebno je provesti identifikaciju tvari, analizirati različite razine
strukturnog uređenja peptidnih molekula, ispitati njihova fizikalno-kemijska i biološka
svojstva te utjecaj na organizam u smislu imunogenosti te biološke aktivnosti i potentnosti.
Posebnu pažnju treba posvetiti ispitivanju prisutnih i mogućih onečišćenja u djelatnoj tvari te
u završnoj formulaciji. U radu je prikazana karakterizacija dekapeptida ikatibanta upotrebom
novijih osjetljivih analitičkih tehnika.

Abstract (english)

Peptide drugs and their wide therapeutic potential have become more available for patients
around the world when generic peptide drugs entered to drug market. Although there are
still no general guidelines for manufacturing and quality control of peptide drugs,
pharmaceutical industry is working under pressure in order to place generic peptides to the
market so they could accomplish their purpose in medical treatment. Pharmaceutical
companies that are seeking approval for putting generic peptide drugs on the market need to
demonstrate sameness between original and generic peptide drug. This is often challenging
due to the fact that manufacturing processess of original and generic drug could be different.
Wide range of analytical techniques are used in order to establish sameness and justify
equivalence between original and generic peptide drugs. Some of many comparative tests
that have to be done are identification of active pharmaceutical substance, molecule structure
characterization, examination of physicochemical and biological properties such as
biological activity and immunogenicity. Particular attention should be given to impurities
that could be present in the active substance material or final formulation of the drug. In this
Bachelor's Thesis, characterization of decapeptide icatibant using novel sensitive analytical
techniques has also been presented.

• Keywords: peptidni lijekovi; generički peptidi; generički lijekovi; istovjetnost lijeka
• Keywords (english): peptide drugs; generic peptides; generic drugs; sameness
• Language: croatian
• URN:NBN: urn:nbn:hr:163:834646
• Study programme: Title: Pharmacy; Study programme type: university; Study level: integrated undergraduate and graduate; Academic / professional title: magistar/magistra farmacije (magistar/magistra farmacije)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2021-04-29 13:29:12