Osnovna načela proizvodnje i odobravanja nanosličnih lijekova

master's thesis

• Title (english): The basic principles of production and approval of nanosimilars
• Author: Sonja Lukić
• Mentor: Ivan Pepić (mentor)
• Committee member: Ivan Pepić (predsjednik povjerenstva)
• Committee member: Jasmina Lovrić (član povjerenstva)
• Committee member: Lovorka Vujić (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of pharmaceutical technology); Zagreb
• Defense date and country: 2016-02-12, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

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.

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.

• Keywords: nanoslični lijekovi; nanolijekovi; polimerni micelarnim nanonosači; nanočestice željezova oksida; liposomi
• Keywords (english): nanosimilars; nanodrugs; polymeric micelles; iron oxide nanoparticles; liposomes
• Language: croatian
• URN:NBN: urn:nbn:hr:163:491469
• 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: Access restricted to students and staff of home institution
• Created on: 2016-06-10 15:48:07