Ispitivanje stabilnosti farmaceutskih dozirnih oblika

undergraduate thesis

• Title (english): Stability studies for pharmaceutical dosage form
• Author: Andrea Drača
• Mentor: Gordana Matijašić (mentor)
• Committee member: Gordana Matijašić (predsjednik povjerenstva)
• Committee member: Jasna Prlić Kardum (član povjerenstva)
• Committee member: Juraj Šipušić (član povjerenstva)
• Granter: University of Zagreb; Faculty of Chemical Engineering and Technology; Zagreb
• Defense date and country: 2020-09-22, Croatia
• Scientific / art field, discipline and subdiscipline: TECHNICAL SCIENCES; Chemical Engineering

Abstract

Stabilnost je važan faktor koji utječe na kvalitetu, djelotvornost i sigurnost lijeka te su upravo zato studije stabilnosti jedan od temeljnih koraka u istraživanju i razvoju farmaceutskih proizvoda. Ispitivanje stabilnosti provodi se u svim fazama razvoja lijeka, od ispitivanja stabilnosti djelatne tvari do ispitivanja utjecaja pakiranja na stabilnost gotove formulacije. Dugoročne studije ispitivanja stabilnosti provode se s ciljem utvrđivanja roka valjanosti koji je definiran kao vrijeme unutar kojeg proizvod posjeduje iste karakteristike kao i u vrijeme proizvodnje. Svrha ovog rada je ispitati oslobađanje dronedaron-hidroklorida in vitro metodom iz različitih dozirnih oblika te ispitati stabilnost dozirnih oblika nakon tri mjeseca. Korištenjem metoda neovisnih o modelu, opisani su profili oslobađanja djelatne tvari. Na temelju izračunatih vrijednosti faktora razlike i faktora sličnosti može zaključiti da svi ispitani farmaceutski dozirni oblici ostaju stabilni nakon tri mjeseca. Najveću podudarnost profila oslobađanja djelatne tvari prije i nakon ispitivanja stabilnosti pokazuju 3D-tiskane tablete.

Abstract (english)

Stability is an important factor that is related with the quality, efficacy and safety of a drug product. Consequently, stability studies are one of the fundamental steps of pharmaceutical research and development. The stability studies are performed at various stages of drug development, from stability testing of active pharmaceutical ingredient to the influence of packaging materials on the stability of drug products. Long-term stability testing is performed to provide information about the shelf life of a drug product, which is defined as the time-lapse during which the drug product retains within the same characteristics that it possessed at the time of manufacture. The purpose of this study is to investigate the release of dronedarone hydrochloride from different dosage forms by in vitro tests in order to verify the stability of pharmaceutical dosage forms after three months. Drug release profiles are described by using model-independent method. According to calculated values of the difference factors and the similarity factors it can be concluded that all tested dosage forms remain stable during three months. Best compatibility of drug release profiles was observed for 3D-printed tablets.

• Keywords: studije stabilnosti; dozirni oblici; in vitro ispitivanje; faktor sličnosti; faktor razlike
• Keywords (english): stability studies; dosage forms; in vitro methods; similarity factor; difference factor
• Language: croatian
• URN:NBN: urn:nbn:hr:149:204053
• Study programme: Title: Chemical Engineering - Undergraduate study; Study programme type: university; Study level: undergraduate; Academic / professional title: sveučilišni/a prvostupnik/ prvostupnica (baccalaureus/baccalaurea) inženjer/inženjerka kemijskog inženjerstva (sveučilišni/a prvostupnik/ prvostupnica (baccalaureus/baccalaurea) inženjer/inženjerka kemijskog inženjerstva)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2023-05-03 11:36:04