Title Utjecaj sastava mješavina na svojstva gotovih tableta Title (english) Effect of mixture composition on tablet properties Author Matija Gretić Mentor Gordana Matijašić (mentor)Committee member Gordana Matijašić (predsjednik povjerenstva)Committee member Krunoslav Žižek (član povjerenstva)Committee member Bruno Zelić (član povjerenstva)Granter University of Zagreb Defense date and country 2015-07-17, Croatia Scientific / art field, TECHNICAL SCIENCES Abstract Svojstva koja čine tablete jednim od najboljih oblika gotovih lijekova su jednostavan način primjene i mogućnost preciznog doziranja djelatne tvari u tabletu prilikom proizvodnje kao i u liječenju. Kvalitetnim izborom pomoćnih tvari i primjenom tehnoloških postupaka moguće je oblikovati različite vrste farmaceutskih oblika te utjecati na svojstva gotovih tableta. Cilj ovog rada bio je ispitivanje utjecaja sastava mješavina za tabletiranje na svojstva gotovih tableta i ujednačenost sadržaja djelatne tvari, omeprazola. U eksperimentu je korišteno sedam komponenata iz kojih je pripremljeno pet različitih mješavina za tabletiranje. Kao osnovna komponenta u svim mješavinama korištena je granulirana saharoza dobivena granuliranjem usitnjene saharoze p.a. uz dodatak veziva polivinilpirolidona (PVP). Mikrokristalinična celuloza (MCC), manitol, laktoza te PanExcea MC200G izvorna i granulirana, korištene su kao sredstva za dopunjavanje u mješavinama. U svaku mješavinu kao sredstvo za klizenje dodano je 3 % magnezijevog stearata. Pojedinačnim komponentama i mješavinama određena je raspodjela veličina čestica, kut mirovanja, nasipna gustoća i gustoća nakon sabijanja te su izračunati indeksi kompresibilnosti i Hausnerov omjer. Postupak tabletiranja proveden je na ekscentričnoj tabletirki s jednim parom klipova te je na dobivenim tabletama ispitana raspadljivost, tvrdoća, dimenzije i rastrošljivost. Odabirom najpogodnije mješavine i tablete najboljih karakteristika dobivena je osnova za dodatak djelatne tvari, omeprazola. Omeprazol je dodan na dva načina, u procesu miješanja i u procesu granuliranja u fluidiziranom sloju. Osim provedenih standardnih testova karakterizacije, na dobivenima tabletama omeprazola provedeno je ispitivanje sadržaja djelatne tvari u 10 nasumično odabranih tableta. Rezultati su pokazali značajan utjecaj raspodjele veličina čestica na svojstva mješavina, a time i na karakteristike tableta. Granuliranje se pokazalo kao ključan korak u procesu izrade tableta jer je postignuta pogodna raspodjela veličina čestica, bolja tecivost mješavina, veća tvrdoća tablete te ujednačeniji sastav omeprazola u tabletama čime se osigurava točnost doziranja djelatne tvari.
Abstract (english) Tablets are the most suitable dosage forms due to the simplicity of use and the possibility of precise dosage of the active ingredient in the tablet during production as well as in treatment. Good selection of excipients and process technologies formulate different types of pharmaceutical dosage forms and affects the properties of the tablet. The aim of this study was to investigate the influence of the mixture composition on tablet properties and to ensure that each tablet contains the correct amount of active ingredient, omeprazole. Five different mixtures were prepared for tableting from seven components. All mixtures contained sucrose that was granulated in fluid-bed with a binder polyvinylpyrrolidone (PVP). Microcrystalline cellulose (MCC), mannitol, lactose and PanExcea MC200G, original and granulated, were used as fillers in prepared mixtures. Magnesium stearate (3 %) was added in each mixture as a glidant. The individual components and mixtures were characterized by the particle size distribution, angle of repose, bulk density and tapped density as well as calculated compressibility index and Hausner ratio. The tableting process was carried out in an eccentric tableting machine with a pair of pistons. Obtained tablets were tested on dissolution, hardness, dimensions and friability. The most appropriate mixture and the tablets of best quality were chosen as the basis for the addition of active substance, omeprazole. Omeprazole was added to the mixture in the process of simple powder blending and granulation process in a fluid-bed. Tablets were subjected to standard characterization tests, and additionally, omeprazole content was determined in 10 randomly selected tablets. The results revealed a significant effect of particle size distribution on the properties of a mixture, and thus the characteristics of tablets. It was shown that the granulation is a crucial step in the tableting process. Granulated materials achieved suitable particle size distribution, better flowability, greater hardness of tablets and more uniform composition of omeprazole in tablets thus ensuring the accuracy of dosage of the active ingredient.
Keywords
granuliranje
tabletiranje
omeprazol
saharoza
polivinilpirolidon
manitol
laktoza
raspodjela veličina čestica
nasipni kut
nasipna gustoća
gustoća nakon potresanja
rastrošljivost
raspadljivost
Keywords (english)
granulation
tableting
omeprazole
sucrose
polyvinylpyrrolidone
mannitol
lactose
particle size distribution
angle of repose
bulk density
tapped density
friability
dissolution
Language croatian URN:NBN urn:nbn:hr:149:036459 Study programme Title: Chemical Engineering - Graduate study Type of resource Text File origin Born digital Access conditions Open access Terms of use Created on 2017-03-06 10:12:07
