709 research outputs found

    Physicochemical testing of plastic packaging systems for solid dosage forms according to USP 661.2.

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    Glavni funkciji ovojnine sta fizična in kemična zaščita farmacevtske oblike. Ovojnina ščiti farmacevtsko obliko pred mehanskimi poškodbami med distribucijo in shranjevanjem, prav tako jo ščiti pred kisikom, toploto, vlago in svetlobo. Ti dejavniki lahko povzročijo kemijske reakcije v farmacevtski obliki in s tem vplivajo na kakovost in varnost farmacevtske oblike. Zagotavljanje kakovosti, varnosti in učinkovitosti končnih izdelkov v farmacevtski industriji je osnovni pogoj za varovanje zdravja bolnikov in uspešno poslovanje farmacevtskega podjetja, zato mora biti tudi plastična ovojnina primerno preskušana. V magistrskem delu smo v skladu s predpisi v monografiji USP 661.2 izvedli fizikalnokemijske preskuse na 10 plastičnih ovojninah, izdelanih iz polietilena z visoko gostoto, ki so se med seboj razlikovale glede na razmerje površine na volumen, proizvajalca, glede na tehnologijo izdelave, barvo in glede različne sestave ovojnin. Preskušane ovojnine se lahko uporabljajo za pakiranje trdnih farmacevtskih oblik. Najprej smo izvedli preliminarno preskušanje kislosti oz. bazičnosti, v sklopu katerega smo izvedli preskus občutljivosti raztopine indikatorja metil rdečega ter preliminarno preskušanje na prečiščeni vodi. Na podlagi preliminarnega preskušanja smo nato s primerjavo rezultatov vrednotili raztopine vzorcev iz 10 ovojnin na treh paralelkah. Po izvedenem preliminarnem testiranju smo izvedli fizikalno-kemijsko preskušanje plastičnih ovojnin, in sicer smo izvedli preskus izgleda raztopine vzorca iz ovojnine (barva in bistrost),izvedli smo meritve absorbance, preskus kislosti oz. bazičnosti, meritve celotnega organskega ogljika ter tudi preskus elementnih nečistot, ki trenutno ni del fizikalnokemijskega preskušanja po USP 661.2.Na podlagi rezultatov smo ugotovili, da so bile vse raztopine vzorcev iz ovojnin brezbarvne in bistre, da so imele vse raztopine vzorcev iz ovojnin vrednost absorbance nižjo od 0,2, da so rezultati kislosti oz. bazičnosti in rezultati meritev celotnega organskega ogljika ustrezali specifikacijskim predpisom v USP 661.2. Iz rezultatov preskusa elementnih nečistot lahko sklepamo, da se v raztopine vzorcev iz ovojnin niso izločile elementne nečistote.Na podlagi vseh izvedenih preskusov torej lahko zaključimo, da vse preskušane ovojnine ustrezajo specifikacijskim predpisom v USP 661.2 in so primerne za uporabo.The main functions of packaging system are the physical and chemical protection of the dosage form. The packaging system protects the dosage form from mechanical damage during distribution and storage, as well as against oxygen, heat, moisture and light. These factors can cause chemical reactions in the dosage form and thus affect the quality and safety of the dosage form. Ensuring the quality, safety and efficacy of finished products in the pharmaceutical industry is a prerequisite for protecting the health of patients and for the successful business performance of a pharmaceutical company, therefore the plastic packaging systems have to be tested properly. The aim of the master thesis was to perform physicochemical tests according to the USP 661.2 monograph on 10 plastic packaging systems made of high-density polyethylene, which were different in terms of size, manufacturer, production technology, colour and packaging composition. The tested packaging systems can be used for the packaging of solid dosage forms. First, we performed a preliminary acidity or alkalinity test, where the test for sensitivity of methyl red indicator and the preliminary test on purified water were performed. On the basis of the preliminary testing we evaluated samples of 10 packaging systems on three parallels by comparing the results. After the preliminary testing, we performed physicochemical testing of plastic packaging systems, we tested the appearance of samples (colour and clarity), we performed the measurements of absorbance, acidity or alkalinity tests, total organic carbon measurements, as well as the test of elemental impurities, which is not yet part of the USP 661.2 physicochemical tests. Based on the results, we concluded that all the samples of packaging system were colourless and clear, all the samples of packaging system had values of absorbance less than 0,2, the results of acidity or alkalinity and also the results of measurements of total organic carbon corresponded to the specifications in USP 661.2. Based on the results of the test for elemental impurities, we can conclude that elemental impurities were not extracted from the packaging systems to the samples. On the basis of all the tests performed, we can conclude that all the packaging systems tested meet the specification requirements of USP 661.2 and are suitable for use

    The impact of the brand\u27s country of origin image on purchase intention

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    Živimo v času, ko lahko izberemo en izdelek, a različnih blagovnih znamk. Potrošnik se pri nakupu ne odloča le, kateri izdelek si želi, ampak izbira tudi med različnimi ponudniki (oz. znamkami) istega izdelka. Ker je izbira res velika, postanejo kupcem pomembni številni dejavniki, med drugim kakovost in podoba blagovne znamke. Namen diplomske naloge je bil raziskati povezavo med podobo države izvora ter kakovostjo, podobo blagovne znamke in nakupno namero. Zanimalo me je predvsem, ali se potrošniki še vedno zanašajo pretežno na izvor izdelka ali jim več pomenijo drugi dejavniki, kot sta kakovost in podoba blagovne znamke. Izsledki kvantitativne analize so pokazali, da se nakupna namera poveča, ko so podoba države izvora, kakovost in podoba blagovne znamke boljši. Ne gre sicer zanemariti ugotovitve, da je vpliv, ki ga ima podoba države izvora na nakupno namero, posreden ter manjši, kot ga imata kakovost in podoba znamke, po drugi strani pa ne smemo pozabiti, da potrošniki pri vrednotenju kakovosti in podobe znamke izhajajo prav iz podobe države izvora.We live in a time where while purchasing a product, we can choose from a variety of different brands. Consumers no longer base their purchase decisions on the type of the products they want, but also their brands. Because of the overwhelming choice, number of factors now impact their decision, including perceived quality and brand image. The aim of the thesis was to investigate the connection between country of origin image, perceived quality, brand image and purchase intention. My main goal was to explore whether consumers still predominantly rely on the origin of the product when making purchasing decisions, or are there other, more important factors involved such as quality and brand image. The results of the quantitative analysis suggest that purchase intention indeed increases with better country of origin image, perceived quality and brand image. While it is true that the influence of the country of origin image on purchase intention is indirect and lower than that of the perceived quality and brand image, it should not be forgotten that it is the image of the country of origin that consumers rely on when forming judgements about the quality and brand image

    Elemente der Montessori-Pädagogik beim DaF-Unterricht

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    In dieser Diplomarbeit ist ein didaktischer Vorschlag dargestellt, wie man den klassischen DaF-Unterricht mit den Elementen der Montessori-Pädagogik bereichern kann. Anhand verschiedener Fachliteratur sind die Anfänge der Montessori-Pädagogik und die Entwicklung der Wortartensymbole von Maria Montessori präsentiert. An einigen praktischen Beispielen und zwei ausgeführten Unterrichtsstunden ist die mögliche Handhabung mit den Wortartensymbolen beim DaF-Unterricht gezeigt. Der Analyse der ausgeführten Unterrichtsstunden folgt der Schluss, dass es durchaus möglich ist, die Elemente der Montessori-Pädagogik in den DaF-Unterricht zu integrieren.V diplomskem delu je podan didaktičen predlog, kako obogatiti klasičen pouk nemščine kot tujega jezika z elementi pedagogike montessori. Na podlagi različne strokovne literature so predstavljeni začetki pedagogike montessori in razvoj simbolov za besedne vrste, ki jih je razvila Maria Montessori. S praktičnimi primeri in izvedbo dveh učnih ur v razredu je prikazana možnost uporabe simbolov za besedne vrste pri pouku nemščine kot tujega jezika. Analizi izvedenih učnih ur sledi sklep, da je elemente pedagogike montessori mogoče integrirati v klasični pouk nemščine kot tujega jezika

    Institutionalizing ASEAN: celebrating Europe through network governance

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    This article provides a new piece for two of the puzzles of institutionalized cooperation in Association of Southeast Asian Nations (ASEAN). First, with regard to the organization's four decades of existence, there has always been a marked gap between ASEAN's rhetorical goals of cooperation and its actual achievements. What explains these systematic failures of implementation? Second, from the outset, ASEAN was criticized for its light institutionalization, which failed to deliver the substantial cooperation goals. Despite selected institutional reforms, ASEAN's autonomy has not increased remarkably and it has not made any major institutional innovations. Why does ASEAN design institutions it does not use? Why does this transformation gap occur? The author suggests a sociological institutional explanation and argues that major impulses for cooperation have come from outside Southeast Asia, most importantly from Europe. By mimicking the European integration process, ASEAN member states have effectively created an isomorphic organization. The Association's institutional development reflects a concern for international legitimacy and less an objective functional demand arising from the specific interactions of member states. This copying process has led to network governance within the organization

    Basel II in CAD 3

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