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Razvoj in vrednotenje redisperzibilnih posušenih emulzij s simvastatinom, izdelanih z metodo oblaganja pelet
Hauko, Saša (Author), Dreu, Rok (Mentor) More about this mentor... This link opens in a new window, Pohlen, Mitja (Co-mentor)

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Abstract
Emulzije so učinkoviti pristop povečanja biološke uporabnosti slabo vodotopnih učinkovin, vendar se pogosto srečujemo s pojavom flotacije, koalescence in Ostwaldovim zorenjem ter fazno inverzijo, kar povzroča težave s stabilnostjo teh dvofaznih sistemov. Ena od strategij za izboljšanje lastnosti klasičnih emulzij je njihovo preoblikovanje v posušene emulzije. V sklopu magistrske naloge smo z metodo zvrtinčenih plasti obložili pelete z emulzijo O/V, v katero je bila v oljno fazo vgrajena modelna učinkovina simvastatin, v vodni fazi pa raztopljen hidrofilni matriks ogrodja emulzije. Cilj magistrske naloge je bil razviti in izdelati s posušeno emulzijo obložene pelete, ki bodo izkazovale ustrezno fizikalno ter kemijsko stabilnost ter kot take v ločeni študiji potencialno izkazovale izboljšane biofarmacevtske lastnosti v primerjavi s klasično oblikovanim izdelkom na trgu. S preliminarnimi testi smo določali sestavo emulzije in določali kar najbolj optimalne procesne parametre. Za dosego optimizacije sestav formulacij emulzije smo ob izbrani procesni komori in vrednostih procesnih spremenljivk uporabili dve kritični lastnosti izdelka - odziva (sposobnost rekonstitucije emulzije in parameter enomesečne stabilnosti učinkovine) in ju po konceptu načrtovanja eksperimentov popisali z matematičnima modeloma. Pelete obložene s posušeno emulzijo so izkazovale ustrezno majhno širino porazdelitve velikosti, okroglo obliko in vsebnost vode manjšo od 1,5 %. Optimizirane formulacije so po rekonstituiranju v vodnem mediju izkazovale ozko porazdelitev velikosti kapljic olja z učinkovino, ustrezno stabilnost, učinkovito vgradnjo zdravilne učinkovine in izboljšani profil sproščanja v primerjavi z ne-lipidno formulacijo tablet, ki je trenutno dostopna na trgu in v primerjavi s čisto učinkovino.

Language:Slovenian
Keywords:LIPIDNI SISTEMI EMULZIJA POSUŠENA EMULZIJA TEHNOLOGIJA ZVRTINČENIH PLASTI SIMVASTATIN INTESTINALNI LIMFNI TRANSPORT
Work type:Master's thesis/paper (mb22)
Organization:FFA - Faculty of Pharmacy
Year:2020
Views:142
Downloads:69
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Secondary language

Language:English
Title:Development and evaluation of redispersible dry emulsion systems containing simvastatin, produced by using fluid bed coating
Abstract:
Emulsions are an effective approach to increase the bioavailability of poorly water-soluble active ingredients, but we often come across occurrence of flotation, coalescence and Ostwald ripping, as well as phase inversion, which causes problems with the stability of these two-phase systems. One of the strategies for improving the disadvantages of classical emulsions is their transformation into dried emulsions. As part of the master's thesis, pellets were coated with an O/W emulsion using the fluidized bed method, in which the active ingredient simvastatin was incorporated into the oil phase and the hydrophilic matrix of the emulsion framework was dissolved in the aqueous phase. The aim of the master's thesis was to develop and produce dried emulsion coated pellets that will show adequate physical and chemical stability and as such in a separate study potentially show improved biopharmaceutical properties compared to the classically designed product on the market. Preliminary tests were used to determine the composition of the emulsion and to determine the most optimal process parameters. To achieve optimization of the composition of emulsion formulations, we used two critical product properties - responses (ability to reconstitute emulsion and one-month stability parameter of the active ingredient) and showed them with mathematical models according to the concept of experimental design. Pellets coated with dried emulsion showed a correspondingly low size distribution width, round shape and water content less than 1.5 %. After reconstitution in aqueous medium, the optimized formulations showed a narrow distribution of oil droplet size with the active ingredient, adequate stability, effective drug incorporation and an improved release profile compared to the non-lipid tablet formulation currently available on the market and compared to the the pure active ingredient.

Keywords:LIPID BASED SYSTEMS EMULSION DRY EMULSION FLUID BED COATING TECHNOLOGY SIMVASTATIN INTESTINAL LYMPHATIC DRUG TRANSPORT

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