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Vrednotenje segregacije binarnih zmesi s sferično kristalizirano laktozo
ID Grilc, Blaž (Author), ID Planinšek, Odon (Mentor) More about this mentor... This link opens in a new window

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Abstract
Segregacija zmesi je v farmacevtski industriji velik problem, za katerega ne poznamo preproste univerzalne rešitve. Najpomembnejši vpliv ima v procesu direktnega tabletiranja. Pri tem procesu izdelave trdnih farmacevtskih oblik uporabljamo zmesi zdravilne učinkovine in pomožnih snovi. Pripravljene zmesi so izpostavljene specifičnim mehanskim obremenitvam, ki povzročajo preurejanje delcev. Vsaka sprememba v lokalni sestavi zmesi direktno vpliva na enakomernost vsebnosti zdravilne učinkovine v posamezni odmerni enoti. Zato je vsakršno preurejanje delcev med procesom tabletiranja problematično in nezaželeno. Določene zmesi so bolj dovzetne za pojav segregacije, medtem ko so lahko druge povsem homogene, ob enakih okoljskih dejavnikih. Stopnje segregacije določene zmesi zaradi kompleksnosti sistema ne moremo vnaprej napovedati. V primeru, ko ne moremo zagotoviti zadostne robustnosti zmesi, moramo pred procesom stiskanja tablet izvesti dodatno procesno operacijo granulacije zmesi. Vsaka dodatna procesna stopnja pa predstavlja strošek in nevarnost za kontaminacijo izdelka. Zato si za izdelavo trdnih farmacevtskih oblik želimo postopek direktnega stiskanja tablet. V magistrski nalogi smo se lotili preučevanja lastnosti segregacije različnih laktoz. Primerjali smo komercialno dostopne laktoze z modificirano laktozo, ki smo jo pripravili na fakulteti. Vse laktoze, ki smo jih preučevali, so primerne za proces direktnega stiskanja tablet, saj izkazujejo dobre pretočne lastnosti in imajo primerno kompresibilnost ter kompaktibilnost. Komercialno dostopni laktozi sta bili Flowlac® 100 in Tabletose® 70. Modificirano laktozo pa smo pripravili s postopkom sferične kristalizacije po metodi dodatka netopila k raztopini. Ugotavljali smo vezavo modelne zdravilne učinkovine na površino laktoze in tvorbo urejenih zmesi. Pripravili smo zmesi treh različnih snovi z laktozami v dveh razmerjih in sicer z 12,5 % in 25 % zdravilne učinkovine. Z metodami nasutega stožca, vrtljivega bobna in sejanja na sitih smo preučevali stopnjo segregacije posamezne zmesi. Segregacija je pojem, ki nima količine, s katero bi jo lahko absolutno opisali. Rezultat vseh meritev je predstavljen v obliki primerjave med različnimi zmesmi. Iz dobljenih rezultatov smo ugotovili, da je sferično aglomerirana laktoza bistveno manj dovzetna za pojav segregacije od komercialno dostopnih. Zaradi svojih odličnih lastnosti predstavlja velik potencial za uporabo v proizvodnji trdnih farmacevtskih oblik.

Language:Slovenian
Keywords:segregacija laktoze sferična kristalizacija urejena zmes pomožne snovi
Work type:Master's thesis/paper
Typology:2.09 - Master's Thesis
Organization:FFA - Faculty of Pharmacy
Place of publishing:Ljubljana
Publisher:[B. Grilc]
Year:2015
Number of pages:VI, 43 f.
PID:20.500.12556/RUL-121045 This link opens in a new window
UDC:661.12(043.3)
COBISS.SI-ID:3959665 This link opens in a new window
Publication date in RUL:29.09.2020
Views:1152
Downloads:101
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Secondary language

Language:English
Title:Evaluation of segregation of binary mixtures with spherical crystalized lactose
Abstract:
Segregation of mixtures is a major problem in pharmaceutical industry for which we do not possess a standard solution. It has the most significant impact in process of direct tableting. In this process raw mixtures of the active pharmaceutical ingredient and excipients are used. During the production the mixtures are exposed to different mechanical stresses, which cause segregation of particles. Every deviation in homogeneity of mixture leads to the difference in uniformity of content of a single dosage form. There are different types of mixtures, some are very delicate to handle and the others can retain their homogeneity even at more harsh conditions. Complexity of the system is the reason why we can not predict the level of segregation. Segregation data of mixtures is experimentally determined. There are situations in which we can not prepare mixtures that are robust enough. And we must add additional process of granulation before tableting. Every extra process is connected with higher cost of production and there exists a higher possibility of contamination of the product. This master thesis was devoted to examination of segregation properties of different types of lactose. We have compared commercially available lactoses with a modified lactose which we prepared at the faculty. All examined excipients are appropriate for the usage in the process of direct tableting, because they exhibit good compressibility, compactness and flowing properties. Commercially available lactoses which we examined were Tabletose® 70 and Flowlac® 100. Modified lactose has been prepared by spherical crystallisation with a method solvent, anti-solvent. We have examined the bond between the lactose and a model active pharmaceutical ingredient and possible forming of organised mixtures. We have prepared mixtures of various active pharmaceutical ingredients with lactoses with different content (12.5 % and 25 %) of the active pharmaceutical ingredient. We have used the cone forming method, rotating drum and moving of powders through the sieve to determine the level of segregation. Segregation could not be quantified because there is no measurable unit of segregation. Therefore the result of any measurement is a comparison between different mixtures. Results have shown that mixtures with the modified lactose are at least twice less subjected to segregation than mixtures with commercially available lactoses. Because of the excellent properties of the modified lactose there is a huge potential in its application in the process of direct tableting.

Keywords:segregation of lactose spherical crystalisation organised mixtures excipients

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