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Razvoj metode za vrednotenje sproščanja paracetamola iz granul, napolnjenih v slamice = Development of a method for evaluation of paracetamol dissolution from granules packed in straws : magistrski študijski program Industrijska farmacijaMinova, JasminaTesti, ki dokazujejo kakovost zdravila, omogočajo pridobitev dovoljenja za trženje. Trenutne konvencionalne zahteve za trdne farmacevtske oblike navajajo test razpadnosti in/oz. test sproščanja kot ... ključne za vrednotenje kakovosti teh zdravil. Pri večini zdravil so postopki, ki jih moramo uporabljati za dokazovanje zdravila, znani in natančno definirani. Izziv se pojavi pri vrednotenju trdnih farmacevtskih oblik - s specifično sestavo in obliko, pri katerih je implementacija veljavnih navodil in monografij otežena, ter ne odražajo dejanske kakovosti zdravila. Magistrska naloga je usmerjena na razvoj metode za vrednotenje sproščanja paracetamola iz zrnc, napolnjenih v slamice. Pri razvoju smo upoštevali monografije evropske in ameriške farmakopeje. Praktični del je bil razdeljen v tri faze. Prva faza povzema validacijske parametre, definirane v skladu z mednarodno konferenco o harmonizaciji. Vrednotili smo ustreznost analizne metode v smislu specifičnosti, linearnosti in razpona linearnosti, ponovljivosti ter stabilnosti raztopin. Za boljše osnovno razumevanje fizikalno-kemijskih lastnosti paracetamola smo izvedli še preliminarne študije, ki predstavljajo drugo fazo praktičnega dela magistrske naloge. V tej fazi smo vrednotili parametre, kot so topnost zdravilne učinkovine, kompatibilnost filtrov različnih materialov, volumen in sestava medija ter ustreznost aparata USP 1 in aparata USP 2. V zadnji fazi smo razvili postopek izvedbe analize za vrednotenje granul. Izbrali smo parametre: vrsto prezračenosti medija, hitrost vrtenja mešala in vpliv hidrodinamike na pojav učinka stožca; vsi našteti parametri so bili ovrednoteni. Kljub uradnim navodilom je bil izveden še preizkus zmožnosti prekrivanja neprijetnega okusa paracetamola kot parameter za nadzor kakovosti končne farmacevtske oblike.Type of material - master's thesis ; adult, seriousPublication and manufacture - Ljubljana : [J. Minova], 2020Language - slovenianCOBISS.SI-ID - 31213059
Author
Minova, Jasmina
Other authors
Planinšek, Odon
Topics
Farmacevtska tehnologija |
Analizna kemija |
sproščanje učinkovin |
paracetamol |
zrnca |
aparat USP 1 |
aparat USP 2 |
v kislini topni polimer
Library/institution |
City | Acronym | For loan | Other holdings |
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Faculty of Pharmacy, Ljubljana | Ljubljana | FFALJ |
reading room 1 cop.
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Database name | Field | Year |
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Links to authors' personal bibliographies | Links to information on researchers in the SICRIS system |
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Minova, Jasmina | |
Planinšek, Odon | 14935 |
Source: Personal bibliographies
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