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A study of in situ fluid bed melt granulation using response surface methodology
Kukec, Simon (Author), Vrečer, Franc (Author), Dreu, Rok (Author)

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Abstract
The objective of this work was to investigate the influence of selected individual variables (binder content, inlet air temperature, and product end point 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 end point 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.

Language:English
Keywords:granulacija s talinami v zvrtinčenih plasteh, karvedilol, središčni mešani načrt, prenos v večje merilo
Work type:Not categorized (r6)
Tipology:1.01 - Original Scientific Article
Organization:FFA - Faculty of Pharmacy
Year:2012
Number of pages:str. 497-513
Numbering:Vol. 62, no. 4
UDC:66.02+661.12:615.014
ISSN on article:1330-0075
DOI:10.2478/v10007-012-0033-y Link is opened in a new window
COBISS.SI-ID:3368049 Link is opened in a new window
Views:683
Downloads:97
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Record is a part of a journal

Title:Acta pharmaceutica
Shortened title:Acta pharm.
Publisher:Hrvatsko farmaceutsko društvo
ISSN:1330-0075
COBISS.SI-ID:13497349 This link opens in a new window

Secondary language

Language:English
Title:Uporaba metodologije odgovornih površin za študij in situ granulacije s talinami v zvrtinčenih plasteh
Abstract:
V raziskovalnem delu smo z uporabo tri-faktorskega pet-nivojskega središčnega mešanega eksperimentalnega načrta proučevali vpliv izbranih procesnih spremenljivk (delež veziva, temperatura vhodnega zraka in končna temperatura produkta) in situ granulacije s talinami na porazdelitev velikosti izdelanih granul in na delež raztopljenega karvedilola. Ugotovili smo, da povečana količina veziva v formulaciji kaže učinek povečanja velikosti izdelanih granul kakor tudi hitrosti raztapljanja karvedilola. Prav tako smo ugotovili, da temperatura vhodnega zraka in končna temperatura produkta izkazujeta izrazit vpliv na parametre velikosti granul. Z metodo odgovornih površin smo znotraj proučevanih intervalov določili in validirali optimalno količino veziva in optimalne procesne parametre. Z uporabo optimalnih formulacijskih in procesnih parametrov smo tehnologijo in situ granulacije s talinami uspešno prenesli iz laboratorijskega v večje (pilotno) merilo, pri čemer smo zagotovili primerljivost proučevanih lastnosti granulata.


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