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Izvorni znanstveni članak
https://doi.org/10.2478/v10007-012-0033-y

Study of in situ fluid bed melt granulation using response surface methodology

SIMON KUKEC ; Krka, d.d., 8501 Novo mesto, Slovenia
FRANC VREČER ; Krka, d.d., 8501 Novo mesto, Slovenia; University of Ljubljana, Faculty of Pharmacy, 1000 Ljubljana, Slovenia
ROK DREU ; University of Ljubljana, Faculty of Pharmacy, 1000 Ljubljana, Slovenia

Puni tekst: engleski, pdf (2 MB) str. 497-513 preuzimanja: 726* citiraj
APA 6th Edition
KUKEC, S., VREČER, F. i DREU, R. (2012). Study of in situ fluid bed melt granulation using response surface methodology. Acta Pharmaceutica, 62 (4), 497-513. https://doi.org/10.2478/v10007-012-0033-y
MLA 8th Edition
KUKEC, SIMON, et al. "Study of in situ fluid bed melt granulation using response surface methodology." Acta Pharmaceutica, vol. 62, br. 4, 2012, str. 497-513. https://doi.org/10.2478/v10007-012-0033-y. Citirano 07.12.2019.
Chicago 17th Edition
KUKEC, SIMON, FRANC VREČER i ROK DREU. "Study of in situ fluid bed melt granulation using response surface methodology." Acta Pharmaceutica 62, br. 4 (2012): 497-513. https://doi.org/10.2478/v10007-012-0033-y
Harvard
KUKEC, S., VREČER, F., i DREU, R. (2012). 'Study of in situ fluid bed melt granulation using response surface methodology', Acta Pharmaceutica, 62(4), str. 497-513. https://doi.org/10.2478/v10007-012-0033-y
Vancouver
KUKEC S, VREČER F, DREU R. Study of in situ fluid bed melt granulation using response surface methodology. Acta Pharm. [Internet]. 2012 [pristupljeno 07.12.2019.];62(4):497-513. https://doi.org/10.2478/v10007-012-0033-y
IEEE
S. KUKEC, F. VREČER i R. DREU, "Study of in situ fluid bed melt granulation using response surface methodology", Acta Pharmaceutica, vol.62, br. 4, str. 497-513, 2012. [Online]. https://doi.org/10.2478/v10007-012-0033-y

Sažetak
The objective of this work was to investigate the influence of selected individual variables (binder content, inlet air temperature, and product endpoint temperature) of in situ fluid bed melt granulation on the granule particle size distribution and percentage of dissolved carvedilol using a three-factor, five-level circumscribed central composite design. Increased binder content had the effect of increasing the granule particle size and drug dissolution rate. The effect of inlet air temperature and product endpoint temperature was found to be more pronounced in case of granule particle size parameters. Within the studied intervals, the optimal quantity of binder as well as optimal process parameters were identified and validated using response surface methodology. Utilizing these optimal process and formulation parameters, successful scaling up of the fluid bed melt granulation process was carried out. Granule characteristics obtained at pilot scale are comparable to those obtained at laboratory scale.

Ključne riječi
fluid bed melt granulation; carvedilol; central composite design; scale-up

Hrčak ID: 87232

URI
https://hrcak.srce.hr/87232

[slovenski]

Posjeta: 1.031 *