837 KB37 KB199820252007Kotar-Jordan, BertaSmrkolj, MatejVrbinc, MihaVrečer, Francštevilka:2letnik:54str. 254-267ISSN:1318-0207COBISSID:2149233URN:URN:NBN:SI:doc-PML2MJYFenSlovensko kemijsko društvoActa chimica slovenicadonepezil hidrokloridhidratikarakterizacijapolimorfijaCharacterization of Physical Forms of Donepezil Hydrochloride|Different crystal forms and amorphous form of donepezil hydrochloride were prepared and characterized, using various analytical techniques. Hydrate form I is stable only at lower relative humidity (RH), while at higher RH it sorbesadditional water. Forms II, III and V were identified as polymorphs, whereas form III is thermodynamically stable. Form V was prepared by heating of hydrate IV at high temperature (about 150 °C). Three different forms of hydrate IV were obtained and characterized. Differential scanning calorimetry and X-ray powder diffraction are the most promising analytical methods for differentiation between crystal forms, both polymorphs and hydrates. Methods could be also used in determination of physical form of a drug, incorporated into solid dosage form. Thermal methods explain the most significant difference in dehydration of different forms IVČ transformation to pure polymorphic forms or mixture thereof. On heating of hydrates I and IV-1, two novel crystal forms were prepared and characterized, namely crystal forms VII and VIIIPripravili in karakterizirali smo razliene kristalne oblike in amorfno obliko donepezil hidroklorida. Hidrat I je stabilen le pri nizki relativni vlaznosti in pri visji relativni vlaznosti absorbira vodo. Oblike II, III in V so polimorfi, termodinamsko je stabilna oblika III. Oblika V nastane s segrevanjem hidrata IV pri temperaturi okrog 150 °C. Pripravili in karakterizirali smo tri oblike hidrata IV. Kot najprimernejsi metodi za doloeitev kristalnih oblik, tako polimorfov kot hidratov, sta se izkazali diferenena dinamiena kalorimetrija (DSC) in rentgenska praskovna analiza. Metodi sta uporabni tudi za doloeitev oblike donepezil hidroklorida v trdni farmacevtski obliki. S termieno analizo smo ugotovili razlike v dehidratacijirazlienih oblik hidrata IV, to je prehod v eisto polimorfno obliko ali v zmes polimorfov. Segrevanje hidratov I in IV-1 daje novi kristalni obliki VII in VIIITEXTznanstveno časopisjejournalsSlovenian National E-content AggregatorNational and University Library of SloveniaSlovensko kemijsko društvo