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Študij fizikalne stabilnosti hidratne oblike K-0502 = Study of physical stability of hidrate form K-0502 : diplomska nalogaRibič, LarisaSposobnost spojine, da obstaja v veè kot eni kristalni obliki imenujemo polimorfizem. Razliène polimorfne modifikacije (polimorfi) se med seboj razlikujejo le v trdnem stanju, v tekoèem in plinastem ... stanju pa med njimi razlik ni. Medtem, ko polimorfizem pomeni razlièno ureditev kristalne resetke enakih molekul, pa psevdopolimorfizem predstavlja razlièno kristalno ureditev vsaj dveh razliènih molekul, t.j. trdne snovi in topila. Veèina zdravilnih uèinkovin je podvrzena polimorfizmu in psevdopolimorfizmu in priblizno tretjina jih je sposobna tvoriti kristaliniène hidrate.Pogost vzrok za fizikalno, kemijsko in biofarmacevtsko nestabilnost so neprièakovani medfazni prehodi v konèni farmacevtski obliki. Te spremembe moramo razumeti, spremljatiin kontrolirati, saj vplivajo na proces proizvodnje in na uèinkovitost produkta. V izogib tezavam med proizvodnjo in shranjevanjem, morazato biti prouèevanje polimorfizma in pseudopolimorfizma surovin in gotovih izdelkov vkljuèeno v predformulacijske studije.Namen naloge je bil preuèiti vpliv temperature in relativne vlaznosti zraka na fizikalno stabilnost èiste hidratne oblike K- 0502. V nalogi smo prouèevali fizikalne spremembe osnovne hidratne oblike- same in v binarnih zmeseh z izbranimi pomoznimi snovmi, pod vplivom obremenitve s temperaturo in vlago. Vpliv relativne vlaznosti zraka smo preuèevali z DVS in XRPD (in situ), spremembe pod vplivom temperature pa s pomoèjo DSC, TGA in XRPD.Ugotovili smo, da RV, oziroma posledièno adsorpcija vode, ne vpliva na fizikalno stabilnost nasega vzorca. Po izpostavitvi razliènim vrednostim RV, kristalna struktura osnovnegamonohidrata ostane nespremenjena. V nasprotju z RV, pa vzorci kazejo razlièno obnasanje pri termièni obremenitvi. Pri in situ segrevanju v rentgenudo 200°C, pri vseh treh vzorcih oblike I, zasledimo pojav dehidratacije osnovnega monohidrata v obliki A in B. Zasledimo tudi pojav novih faz (NF1 in NF2), z to razliko, da se NF2 pri vzorcu K - 0502ž 03 ne pojavi, v primerjavi z drugima dvema vzorcema K - 0502ž 01 in K - 0502ž 02. Vzorec K - 0502ž 02 kaze manjso fizikalno stabilnost v binarnih zmeseh kot vzorec K - 0502ž 03. Najhitreje prehod oblike I v obliko B zasledimo pri binarni zmesi, ki je sestavljena iz 20% vzorca K - 0502ž 02 in 80% mikrokristaliniène celuloze (MCC).Type of material - undergraduate thesisPublication and manufacture - Ljubljana : [L. Ribič], 2007Language - slovenianCOBISS.SI-ID - 2146929
Author
Ribič, Larisa
Other authors
Kos, Janko, 1959- |
Grčman, Marija
Topics
polimorfizem |
kristalinične snovi |
kapilarna kondenzacija |
dinamična diferenčna kalorimterija |
infrardeča spektroskopija |
analiza |
adsorpcija
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Library/institution |
City | Acronym | For loan | Other holdings |
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Faculty of Pharmacy, Ljubljana | Ljubljana | FFALJ |
reading room 2 cop.
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Database name | Field | Year |
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Links to authors' personal bibliographies | Links to information on researchers in the SICRIS system |
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Ribič, Larisa | ![]() |
Kos, Janko, 1959- | 04648 |
Grčman, Marija | 12417 |
Source: Personal bibliographies
and: SICRIS
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