Studies on upscaling parameters of the Gral high shear granulation process

Horsthuis, G.J.B.; Laarhoven, J.A.H. van; Rooij, R.C.B.M. van; Vromans, Herman

doi:10.1016/0378-5173(93)90273-i

Cited by 62 publications

(16 citation statements)

References 3 publications

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“…There are multiple methods to scale up the high shear wet granulation process. These include keeping constant impeller speed,18 keeping constant normalized impeller power,19 and keeping constant Froude number 20. In addition, work has been done to scale up the wet granulation process based on a rheological model 21.…”

Section: Resultsmentioning

confidence: 99%

Formulation Development and Process Scale Up of a High Shear Wet Granulation Formulation Containing a Poorly Wettable Drug

Lunday

et al. 2008

Journal of Pharmaceutical Sciences

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Section: Resultsmentioning

confidence: 99%

Formulation Development and Process Scale Up of a High Shear Wet Granulation Formulation Containing a Poorly Wettable Drug

Lunday

et al. 2008

Journal of Pharmaceutical Sciences

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“…According to Horsthuis et al (11), scaling up needs to be performed by keeping the Froude number constant, as this results in comparable temperatures and size distributions, whereas a constant relative swept volume and a constant impeller tip speed do not. Our own measurements confirm this statement.…”

Section: Granulationmentioning

confidence: 99%

The Relation Between Granule Size, Granule Stickiness, and Torque in the High-Shear Granulation Process

et al. 2005

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“…Therefore, DoE studies on establishing a design space have often been conducted on a manufacturing scale smaller than the commercial scale based on scale-up rules. Widely used scale-up rules often include a constant Froude number 20 for blending and a constant Froude number 21 or power consumption of the impeller motor 22 for wet high-shear granulation. However, the scale-up of high shear granulation by Ogawa et al indicated that a constant peripheral velocity resulted in a discrepancy in the design spaces between manufacturing scales 12 .…”

Section: Introductionmentioning

confidence: 99%

Novel method to construct large-scale design space in lubrication process utilizing Bayesian estimation based on a small-scale design-of-experiment and small sets of large-scale manufacturing data

Maeda

Suzuki

Takayama

2012

Drug Development and Industrial Pharmacy

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A large-scale design space was constructed using a Bayesian estimation method with a small-scale design of experiments (DoE) and small sets of large-scale manufacturing data without enforcing a large-scale DoE. The small-scale DoE was conducted using various Froude numbers (X(1)) and blending times (X(2)) in the lubricant blending process for theophylline tablets. The response surfaces, design space, and their reliability of the compression rate of the powder mixture (Y(1)), tablet hardness (Y(2)), and dissolution rate (Y(3)) on a small scale were calculated using multivariate spline interpolation, a bootstrap resampling technique, and self-organizing map clustering. The constant Froude number was applied as a scale-up rule. Three experiments under an optimal condition and two experiments under other conditions were performed on a large scale. The response surfaces on the small scale were corrected to those on a large scale by Bayesian estimation using the large-scale results. Large-scale experiments under three additional sets of conditions showed that the corrected design space was more reliable than that on the small scale, even if there was some discrepancy in the pharmaceutical quality between the manufacturing scales. This approach is useful for setting up a design space in pharmaceutical development when a DoE cannot be performed at a commercial large manufacturing scale.

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Studies on upscaling parameters of the Gral high shear granulation process

Cited by 62 publications

References 3 publications

Formulation Development and Process Scale Up of a High Shear Wet Granulation Formulation Containing a Poorly Wettable Drug

Formulation Development and Process Scale Up of a High Shear Wet Granulation Formulation Containing a Poorly Wettable Drug

The Relation Between Granule Size, Granule Stickiness, and Torque in the High-Shear Granulation Process

Novel method to construct large-scale design space in lubrication process utilizing Bayesian estimation based on a small-scale design-of-experiment and small sets of large-scale manufacturing data

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