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master's thesis
42
6
The basic principles of production and approval of nanosimilars
Sonja Lukić (2016)
University of Zagreb
Faculty of Pharmacy and Biochemistry
Department of pharmaceutical technology
Cite this item:
https://urn.nsk.hr/urn:nbn:hr:163:491469
Metadata
Title
Osnovna načela proizvodnje i odobravanja nanosličnih lijekova
Author
Sonja Lukić
Mentor(s)
Ivan Pepić
(thesis advisor)
Abstract
Nanolijekovi su vrlo složeni farmaceutski oblici proizvedeni strogo kontroliranim procesima. Nanolijekovi predstavljaju revoluciju u liječenju brojnih bolesti jer omogućuju ciljanu dostavu lijeka, poboljšavaju topljivost i djelotvornost lijeka, a istodobno smanjuju imunogenost. Nanoslični lijekovi izrađeni su po uzoru na prvu generaciju nanolijekova iako postoje klinički značajne razlike između ove dvije skupine lijekova. Takve razlike predstavljaju veliki izazov u području postavljanja primjerenih regulatornih zahtjeva za proizvodnju i odobravanje nanosličnih lijekova. Ovaj rad daje pregled najčešće korištenih farmaceutskih oblika nanolijekova u kliničkoj praksi kao uvod u raspravu o osnovnim načelima proizvodnje i odobravanja triju farmaceutskih oblika nanosličnih lijekova. Nanoslični lijekovi zasnivaju se na tehnologiji polimernih micela i liposoma te nanočesticama željezova oksida. S ciljem boljeg razumijevanja trenutnog stanja u području odobravanja nanosličnih lijekova, u radu su objašnjena osnovna načela razvoja i ocjene odobrenih nanolijekova. U ovom radu također je objašnjena procjena sigurnosti farmaceutskih oblika nanolijekova kao bitan aspekt pri primjeni takvih lijekova. Nanoslični lijekovi pokazuju veliki potencijal za razvoj i primjenu. Razvoj i odobravanje ostalih skupina nanosličnih lijekova u velikoj mjeri ovisi o utvrđivanju jasnih regulatornih zahtjeva u smislu smjernica za proizvodnju djelotvornih i sigurnih nanosličnih lijekova.
Keywords
nanosimilars
nanodrugs
polymeric micelles
iron oxide nanoparticles
liposomes
Parallel title (English)
The basic principles of production and approval of nanosimilars
Committee Members
Ivan Pepić
(committee chairperson)
Jasmina Lovrić
(committee member)
Lovorka Vujić
(committee member)
Granter
University of Zagreb
Faculty of Pharmacy and Biochemistry
Lower level organizational units
Department of pharmaceutical technology
Place
Zagreb
State
Croatia
Scientific field, discipline, subdiscipline
BIOMEDICINE AND HEALTHCARE
Pharmacy
Pharmacy
Study programme type
university
Study level
integrated undergraduate and graduate
Study programme
Pharmacy
Academic title abbreviation
mag. pharm.
Genre
master's thesis
Language
Croatian
Defense date
2016-02-12
Parallel abstract (English)
Nanomedicines are complex pharmaceuticals which are produced in highy controlled manufacturing processes. They show the ability to provide targeted drug delivery, improve drug solubility and effectiveness. On the other hand they reduce a drug’s immunogenicity. Those positive factors resulted in great potential to revolutionize the treatment of many diseases. Despite the fact that nanosimilars are developed as a follow-on version to nanomedicines they show significant clinical differences which present a great challenge in defining a regulatory framework for manufacturing and registration of these drugs. This work provides an overview of most frequently used nanoparticles as an introduction to discussion on basic principles of manufacturing and marketing authorization of three different nanosimilars. First of them are nanosimilars based od polymeric micelles, second are iron oxide based nanosimilars and third are nanosimilars based on liposomes. To provide better understanding of the current state in regulatory of nanosimilars, this work provides basic principles of development of nanosimilars and evaluation on current state on the market of nanosimilars. Furthermore, in this work safety assessment of nanosimilars is discussed in detail. Due to the enormous potential and rapid growth of nanosimilars on the market, regulatory authorities need to develope a set of guidelines for manufacturing processes and marketing authorization of these medicines. Those guidelines would set a basis to greater number of safe and efficient nanosimilars on the market.
Parallel keywords (Croatian)
nanoslični lijekovi
nanolijekovi
polimerni micelarnim nanonosači
nanočestice željezova oksida
liposomi
Resource type
text
Access condition
Access restricted to students and staff of home institution
Terms of use
URN:NBN
https://urn.nsk.hr/urn:nbn:hr:163:491469
Committer
Petra Gašparac