Influence of granulation and compression process variables on flow rate of granules and on tablet properties, with special reference to weight variation

Merkku, P.; Lindqvist, Ann-Sophie; Leiviskä, Kauko; Yliruusi, Jouko

doi:10.1016/0378-5173(94)90046-9

Cited by 30 publications

(36 citation statements)

References 4 publications

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“…Equations17a−17b show that principal factors for CS and DT are MCC, Moisture and ComF. The plots of the "overlapping responses" method for the data by Merkku et al 9 and Westerhuis et al 10 are shown in Figures 2 and 4, respectively.…”

Section: Methodsmentioning

confidence: 97%

Design Space Approach for Pharmaceutical Tablet Development

Chatzizacharia

Hatziavramidis

2014

Ind. Eng. Chem. Res.

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Methodologies to determine the Design Space of a pharmaceutical product, within which continuous improvement can be implemented and postapproval changes in material attributes and process parameters can be introduced without prior approval, are presented. The type of methodology used depends on the type of experimental data obtained for the purpose of determining the Design Space. However, when one is unsure about the data collected to determine the Design Space, one can determine the quality of the data from successive application of the various methods and evaluation of the desirability measure for each method. The Design Spaces for a two-and three-process tablet manufacturing are determined by Response Surface Method (RSM), Bayesian Post Predictive Approach (BPPA), and Artificial Neural Networks (ANN), based on local or global specification limits of the response variables provided by multiresponse optimization and overlapping responses, respectively. The Response Surface Method is the most effective of these methods in determining the Design Spaces for the aforementioned data sets, confirming that the particular data are complete and lack uncertainty or structure, the specific features that the Bayesian Post Predictive Approach and Artificial Neural Networks methods are suited to address, respectively.

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Section: Methodsmentioning

confidence: 97%

Design Space Approach for Pharmaceutical Tablet Development

Chatzizacharia

Hatziavramidis

2014

Ind. Eng. Chem. Res.

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“…2 and 3, it is reasonably implied that the granules are formed by accumulation of primary particles which are rolled and blended by the fluidizing air within the column. Formation of prepared granule is known as the so-called snowballing mechanism, attributed to the relatively spherical structure [7][8][9].…”

Section: Effect On the Granule Morphologymentioning

confidence: 99%

“…So far, there are several models of granulation mechanisms employed for explaining the formation of granules [1,[7][8][9][10][11][12].…”

Section: Effect On the Granule Morphologymentioning

confidence: 99%

“…They www.elsevier.com/locate/jiec found that using higher feed rate of liquid binder would result in the larger average size of granules. In 1994, Merkku et al studied the effect of granulation process parameters on physical properties of tablets prepared from granules [9]. It was found that binder-atomizing pressure had a significant effect of the friability and dissociation rate of the tablets produced.…”

Section: Introductionmentioning

confidence: 99%

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Granulation and tabletization of pharmaceutical lactose granules prepared by a top-sprayed fluidized bed granulator

Charinpanitkul

Tanthapanichakoon

Kulvanich

et al. 2008

Journal of Industrial and Engineering Chemistry

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“…The fluidization process allows automatically controlled operations and fluid bed granulators are becoming increasingly instrumented including indirect physical measurements, e.g. temperatures, flow rates, and pressure differences (5)(6)(7)(8)(9). Until recently, these measurements have mainly been utilized for monitoring purposes and not for finding critical interactions or variation sources of the processes.…”

Section: Introductionmentioning

confidence: 99%

Particle Size, Moisture, and Fluidization Variations Described by Indirect In-line Physical Measurements of Fluid Bed Granulation

et al. 2008

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Abstract. The aim of this study was to evaluate an instrumentation system for a bench scale fluid bed granulator to determine the parameters expressing the changing conditions during the spraying phase of a fluid bed process. The study focused mainly on four in-line measurements (dependent variables): fluidization parameter (calculated by inlet air flow rate and rotor speed), pressure difference over the upper filters, pressure difference over the granules (lower filter), and temperature of the fluidizing mass. In-line particle size measured by the spatial filtering technique was an essential predictor variable. Other physical process measurements of the automated granulation system, 25 direct and 12 derived parameters, were also utilized for multivariate modeling. The correlation and partial least squares analyses revealed significant relationships between various process parameters highlighting the particle size, moisture, and fluidization effect. Fluidization parameter and pressure difference over upper filters were found to correlate with in-line particle size and therefore could be used as estimates of particle size during granulation. The pressure difference over the granules and the temperature of the fluidizing mass expressed the moisture conditions of wet granulation. The instrumentation system evaluated here is an invaluable aid to gaining more control for fluid bed processing to obtain repeatable granules for further processing.

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Influence of granulation and compression process variables on flow rate of granules and on tablet properties, with special reference to weight variation

Cited by 30 publications

References 4 publications

Design Space Approach for Pharmaceutical Tablet Development

Design Space Approach for Pharmaceutical Tablet Development

Granulation and tabletization of pharmaceutical lactose granules prepared by a top-sprayed fluidized bed granulator

Particle Size, Moisture, and Fluidization Variations Described by Indirect In-line Physical Measurements of Fluid Bed Granulation

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