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Title:DOLOČEVANJE PORAZDELITVE VELIKOSTI DELCEV FARMACEVTSKE UČINKOVINE MOMETASON FUROAT V SUSPENZIJI, S POMOČJO OPTIČNE MIKROSKOPIJE
Authors:Šivec, Daša (Author)
Petek, Aljana (Mentor) More about this mentor... New window
Brodnjak-Vončina, Darinka (Co-mentor)
Svete, Peter (Co-mentor)
Files:.pdf MAG_Sivec_Dasa_2014.pdf (3,41 MB)
MD5: 7B58175E459C3337E49DA5AF8CFD6992
 
Language:Slovenian
Work type:Master's thesis/paper (mb22)
Typology:2.09 - Master's Thesis
Organization:FKKT - Faculty of Chemistry and Chemical Engineering
Abstract:Farmacevtska industrija za določevanje velikosti delcev farmacevtske učinkovine pozna veliko metod, ki se med seboj razlikujejo po principu določevanja in s tem tudi po dobljenih rezultatih. V zadnjem času je razvoj na tem področju zelo napredoval, tako da lahko danes hitro in rutinsko določimo vse vrste velikosti trdnih delcev, tako v suspenziji (npr. nosnih pršilih), kot delce v praškastih materialih. V magistrskem delu je prikazano določevanje velikosti delcev farmacevtske učinkovine s pomočjo optičnega mikroskopa in potrditev le-teh s pomočjo ramanske mikroskopije. Pri prvi tehniki smo uporabljali optični mikroskop s kamero in primerno programsko opremo za analizo slike. Programska oprema nam je omogočila ročno izbiro analiziranih delcev tako, da smo delce učinkovine sami izbrali. S to metodo smo dobili velikost delcev. Druga tehnika – ramanska mikroskopija, nam je s pomočjo ramanskega mikroskopa Renishaw inVia in ustrezne programske opreme potrdila pravilno izbiro določevanih delcev na podlagi ramanskega spektra. Za farmacevtsko učinkovino smo izbrali mometazon furoat, ki smo jo primerjali še z dvema farmacevtskima učinkovinama budezonid in flutikazon furoat v nosnem pršilu. Omenjene farmacevtske učinkovine v nosnem pršilu služijo pri odpravljanju simptomov alergijskega rinitisa. Poleg učinkovine pa nosna pršila vsebujejo tudi avicelno fazo (RC-591), ki deluje kot pomožna snov in vpliva na viskoznost vzorcev. Avicelna faza (RC-591) nas pri sami določitvi velikosti delcev ni zanimala. V magistrskem delu smo primerjali vse tri farmacevtske izdelke med seboj, tako generične kot referenčne. Rezultati kažejo, da smo z ramanskim mikroskopom Renishaw inVia potrdili izbiro pravih delcev učinkovine mometazon furoata, budezonida in flutikazon furoata v nosnem pršilu in ne delcev avicela RC-591. Iz analize velikosti delcev opazimo, da ni razlike med generičnimi in referenčnimi vzorci in da imajo vse analizirane nosne suspenzije enako velike delce učinkovine. Velikost delcev učinkovine mometazon furoat in flutikazon furoat je 9 µm, delci budezonida pa so nekoliko večji, 10 µm. Z ramanskim mikroskopom Renishaw inVia je potrjena hipoteza, da se avicel RC-591 lahko optično loči od mometazon furoata, budezonida in flutikazon furoata.
Keywords:učinkovine (mometazon furoat, budezonid, flutikazon furoat) nosnih pršil, optična mikroskopija, ramanska mikroskopija, velikost delcev, ramanski spekter
Year of publishing:2014
Publisher:[D. Šivec]
Source:Maribor
UDC:543.456:544.2(043.2)
COBISS_ID:18402070 New window
NUK URN:URN:SI:UM:DK:NKVDQN3K
Views:1649
Downloads:77
Metadata:XML RDF-CHPDL DC-XML DC-RDF
Categories:KTFMB - FKKT
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Secondary language

Language:English
Title:DETERMINATION OF THE PARTICLE SIZE DISTRIBUTION OF PHARMACEUTICAL SUBSTANCE MOMETASONE FUROATE IN SUSPENSION, USING OPTICAL MICROSCOPY
Abstract:There is a number of methods known in the pharmaceutical industry for determining the size of particles of a pharmaceutical substance, which are differentiated according to the determination principle and by this according to the received results. There has lately been much progress in the development in this field, meaning that all kinds of particle sizes, either those in suspension (eg nasal sprays) or as dust particles, can be determined nowadays quickly and routinely. The present master thesis presents the determination of the particle size of a pharmaceutical substance using optical microscopy and its confirmation using the raman microscopy. The first method involved an optical microscope with a camera as well as an adequate software for picture analysis. The software made it possible to manually select the analyzed particles, so we selected the particles on our own. This method gave us the particle size. By means of the second method – the raman microscopy – using the raman microscope Renishaw inVia and the adequate software – we were able to confirm the correct selection of particles based on the raman spectrum. As the pharmaceutical substance, mometasone furoate was selected, and a comparison was made with two other pharmaceutical substances, namely budesonide and fluticasone furoate, contained in a nasal spray. The mentioned pharmaceutical substances in a nasal spray help relieve allergic rhinitis symptoms. Besides substance, nasal sprays contain also an avicel RC-591 phase serving as an auxiliary substance influencing the viscosity of samples. The avicel phase (RC-591) was not a subject of our interest as regards the determination of the particle size. The present master thesis compares all three substances, both generics and references, among themselves. The results have indicated that by using the raman microscope Renishaw inVia we were able to confirm the correct selection of particles of the substances mometasone furoate, budesonide, and flutikasone furoate in a nasal spray and not the avicel RC-591 particles. It can be noticed from the particle size analysis that there is no difference between the generics and reference samples and that all analyzed nasal suspensions have substance particles of the same size. The particle size in the mometasone furoate and flutikasone furoate substances is 9 μm, whereas the particles in budesonide are a bit bigger, namely 10 μm. By means of the raman microscope Renishaw inVia, the hypothesis that the avicel RC-591 can be optically distinguished from mometasone furoate, flutikacone furoate, and budesonide, has been confirmed.
Keywords:: pharmaceutical substances (mometasone furoate, budesonide, fluticasone furoate), optical microscopy, raman microscopy, particle size, raman spectrum.


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