<abstract xmlns="http://www.w3.org/1999/xhtml"><p>The objective of this work was to investigate the influence of selected individual variables (binder content, inlet air temperature, and product endpoint temperature) of <italic>in situ </italic>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.</p></abstract>

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.

A study of in situ fluid bed melt granulation using response surface methodology / Uporaba metodologije odgovornih površin za študij in situ granulacije s talinami v zvrtinčenih plasteh

University of Ljubljana, Faculty of Pharmacy, 1000 Ljubljana, Slovenia

Acta Pharmaceutica

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

A study of in situ fluid bed melt granulation using response surface methodology / Uporaba metodologije odgovornih površin za študij in situ granulacije s talinami v zvrtinčenih plasteh

Published Online: Jan 15, 2013

Page range: 497 - 513

DOI: https://doi.org/10.2478/v10007-012-0033-y

Keywords
fluid bed melt granulation, carvedilol, central composite design, scale-up

This content is open access.

A study of in situ fluid bed melt granulation using response surface methodology / Uporaba metodologije odgovornih površin za študij in situ granulacije s talinami v zvrtinčenih plasteh

Published Online: Jan 15, 2013

Page range: 497 - 513

DOI: https://doi.org/10.2478/v10007-012-0033-y

Keywordsfluid bed melt granulation, carvedilol, central composite design, scale-up

This content is open access.

Keywords
fluid bed melt granulation, carvedilol, central composite design, scale-up