20.500.12556/RUL-135172 Procesna analiza krušenja farmacevtske tablete Process analysis of pharmaceutical tablet friability Delo obravnava izzive krušenja in lomljenja farmacevtskih trdih oblik zdravil skozi celotno proizvodnjo. Tudi najmanjša deformacija vodi v izmet polizdelka, do katerega prihaja zaradi gravitacijskih spustov, ki so stalnica v vertikalni proizvodnji. Tablete morajo imeti zadostne mehanske lastnosti, da se preprečijo poškodbe med samim procesom proizvodnje. Hkrati pa morajo biti dovolj šibke, da jih končni uporabnik glede na navodila uporabe sam prelomi na enake dele oziroma se v telesu v določenem časovnem okvirju razgradijo in sprostijo aktivno farmacevtsko snov. V nalogi je predstavljen celoten proces proizvodnje, najpogostejši defekti kot tudi kontrola kakovosti farmacevtskih tablet. Za analizo krušljivosti smo uporabili preprost sistem za izvajanje gravitacijskih spustov iz različnih višin. Rezultate smo primerjali z numeričnimi simulacijami izvajanja farmacevtskega testa trdnosti kot tudi gravitacijskih spustov. Z vidika oblik polizdelkov smo deformacije med seboj primerjali. Ugotovili smo, da je izziv krušenja potrebno obravnavati celostno in ne zgolj z vidika oblike farmacevtskih tablet. The master's thesis addresses challenges of pharmaceutical solid forms of medicines crushing and breaking throughout the entire production process. Even the slightest deformation that can occur due to gravitational descents and are unavoidable in vertical production, lead to the ejection of the product. The tablets must have sufficient mechanical properties to prevent damage during the manufacturing process itself. At the same time, they must be weak enough for the end user to break them into equal parts according to the instructions for use, or for the tablet to decompose and release the active pharmaceutical ingredient in the body within a certain time frame. The thesis presents the entire production, the most common defects as well as quality control of pharmaceutical tablets. For the friability analysis, we used a simple system to perform gravitational descents from different heights. The results were compared with numerical simulations of performing a pharmaceutical strength test as well as gravity descents. We compared the deformations through different product shapes. We found that the challenge of friability needs to be addressed holistically and not just in terms of pharmaceutical tablet shapes. trda farmacevtska oblika zdravila proizvodnja tablet krušljivost lomljenje mehanske obremenitve kontrola kakovosti hard pharmaceutical form of the drug tablet production friability breaking mechanical loads quality control true false false [B. Murn] Slovenski jezik Angleški jezik Magistrsko delo/naloga 2022-02-26 08:30:50 2022-02-26 08:31:02 2022-09-14 04:11:57 0000-00-00 00:00:00 2022 0 Ljubljana 0 XIV, 70 str. 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 615.453.6:620.163.4(043.2) 237883 99937027 13769.pdf 13769.pdf 1 A2094F44E22311387F3D1EB407550533 72e714243e1009610c400ec9198e1ffd78f6f4dcfa9058ad733a166440d11521 c9b58729-96d5-11ec-abdb-00155dcfd717 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=154063 Fakulteta za strojništvo 0 0 0