Design Space Approach in Optimization of Fluid Bed Granulation and Tablets Compression Process

The aim of this study was to optimize fluid bed granulation and tablets compression processes using design space approach. Type of diluent, binder concentration, temperature during mixing, granulation and drying, spray rate, and atomization pressure were recognized as critical formulation and proces...

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Main Authors: Jelena Djuriš, Djordje Medarević, Marko Krstić, Ivana Vasiljević, Ivana Mašić, Svetlana Ibrić
Format: Article
Language:English
Published: Wiley 2012-01-01
Series:The Scientific World Journal
Online Access:http://dx.doi.org/10.1100/2012/185085
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author Jelena Djuriš
Djordje Medarević
Marko Krstić
Ivana Vasiljević
Ivana Mašić
Svetlana Ibrić
author_facet Jelena Djuriš
Djordje Medarević
Marko Krstić
Ivana Vasiljević
Ivana Mašić
Svetlana Ibrić
author_sort Jelena Djuriš
collection DOAJ
description The aim of this study was to optimize fluid bed granulation and tablets compression processes using design space approach. Type of diluent, binder concentration, temperature during mixing, granulation and drying, spray rate, and atomization pressure were recognized as critical formulation and process parameters. They were varied in the first set of experiments in order to estimate their influences on critical quality attributes, that is, granules characteristics (size distribution, flowability, bulk density, tapped density, Carr's index, Hausner's ratio, and moisture content) using Plackett-Burman experimental design. Type of diluent and atomization pressure were selected as the most important parameters. In the second set of experiments, design space for process parameters (atomization pressure and compression force) and its influence on tablets characteristics was developed. Percent of paracetamol released and tablets hardness were determined as critical quality attributes. Artificial neural networks (ANNs) were applied in order to determine design space. ANNs models showed that atomization pressure influences mostly on the dissolution profile, whereas compression force affects mainly the tablets hardness. Based on the obtained ANNs models, it is possible to predict tablet hardness and paracetamol release profile for any combination of analyzed factors.
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issn 1537-744X
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publishDate 2012-01-01
publisher Wiley
record_format Article
series The Scientific World Journal
spelling doaj-art-e4e5a477b6714685944a352541f62df42025-02-03T01:26:04ZengWileyThe Scientific World Journal1537-744X2012-01-01201210.1100/2012/185085185085Design Space Approach in Optimization of Fluid Bed Granulation and Tablets Compression ProcessJelena Djuriš0Djordje Medarević1Marko Krstić2Ivana Vasiljević3Ivana Mašić4Svetlana Ibrić5Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Belgrade, 11221 Belgrade, SerbiaDepartment of Pharmaceutical Technology, Faculty of Pharmacy, University of Belgrade, 11221 Belgrade, SerbiaDepartment of Pharmaceutical Technology, Faculty of Pharmacy, University of Belgrade, 11221 Belgrade, SerbiaDepartment of Pharmaceutical Technology, Faculty of Pharmacy, University of Belgrade, 11221 Belgrade, SerbiaDepartment of Pharmaceutical Technology, Faculty of Pharmacy, University of Belgrade, 11221 Belgrade, SerbiaDepartment of Pharmaceutical Technology, Faculty of Pharmacy, University of Belgrade, 11221 Belgrade, SerbiaThe aim of this study was to optimize fluid bed granulation and tablets compression processes using design space approach. Type of diluent, binder concentration, temperature during mixing, granulation and drying, spray rate, and atomization pressure were recognized as critical formulation and process parameters. They were varied in the first set of experiments in order to estimate their influences on critical quality attributes, that is, granules characteristics (size distribution, flowability, bulk density, tapped density, Carr's index, Hausner's ratio, and moisture content) using Plackett-Burman experimental design. Type of diluent and atomization pressure were selected as the most important parameters. In the second set of experiments, design space for process parameters (atomization pressure and compression force) and its influence on tablets characteristics was developed. Percent of paracetamol released and tablets hardness were determined as critical quality attributes. Artificial neural networks (ANNs) were applied in order to determine design space. ANNs models showed that atomization pressure influences mostly on the dissolution profile, whereas compression force affects mainly the tablets hardness. Based on the obtained ANNs models, it is possible to predict tablet hardness and paracetamol release profile for any combination of analyzed factors.http://dx.doi.org/10.1100/2012/185085
spellingShingle Jelena Djuriš
Djordje Medarević
Marko Krstić
Ivana Vasiljević
Ivana Mašić
Svetlana Ibrić
Design Space Approach in Optimization of Fluid Bed Granulation and Tablets Compression Process
The Scientific World Journal
title Design Space Approach in Optimization of Fluid Bed Granulation and Tablets Compression Process
title_full Design Space Approach in Optimization of Fluid Bed Granulation and Tablets Compression Process
title_fullStr Design Space Approach in Optimization of Fluid Bed Granulation and Tablets Compression Process
title_full_unstemmed Design Space Approach in Optimization of Fluid Bed Granulation and Tablets Compression Process
title_short Design Space Approach in Optimization of Fluid Bed Granulation and Tablets Compression Process
title_sort design space approach in optimization of fluid bed granulation and tablets compression process
url http://dx.doi.org/10.1100/2012/185085
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