Scaling-up of a lactose wet granulation process in Mi-Pro high shear mixers

Ameye, Dieter; Keleb, Eseldin I.; Vervaet, Chris; Remon, Jean Paul; Adams, Erwin; Massart, D.L.

doi:10.1016/s0928-0987(02)00218-x

Cited by 42 publications

(19 citation statements)

References 5 publications

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“…The PTP results verified the excellent taste masking efficiency of formulation D granules as compared to other formulations. These results are in accordance with the previous results (Sharma et al, 2012;Ameye et al, 2002;Ansari et al, 2009;Beatrice et al, 2004). LOD of granules were determined 3.76 ± 0.21, 3.45 ± 0.11, 3.25 ± 0.02 and 4.01 ± 0.01, respectively and results were in the standard range (4.0%).…”

Section: Results and Disscussionsupporting

confidence: 94%

Efficacious formulation of anti-malarial dry suspension for pediatric use

Mohammad¹

2012

Afr. J. Pharm. Pharmacol.

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This study was designed for concealing the bitter taste of an anti-malarial drug, artemether, by using various coating substances. Four granular formulations (formulations A, B, C and D) of artemether were prepared using different excipients and then were coated using methocil™ E5 and opadry ® enteric solutions in a simple coating pan. In the initial 2 min, the cumulative percentage amount of drug release in phosphate buffer at pH 6.8 from pure artemether and formulation A, B, C and D was 59.4 ± 4.2, 55.7 ± 3.5, 48.2 ± 3.8, 43.4 ± 4.1 and 30.8 ± 3.7, respectively. Formulation D exhibited minimum bitterness as its taste masking efficacy (44.73 ± 4.98) was significantly (P < 0.05) greater than other formulations. It can be concluded from results that granules of formulation D prepared by sodium metabisulphite and methyl paraben sodium and coated by opadry ® enteric had maximally reduced the bitterness of artemether with suitable dissolution behavior.

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Section: Results and Disscussionsupporting

confidence: 94%

Efficacious formulation of anti-malarial dry suspension for pediatric use

Mohammad¹

2012

Afr. J. Pharm. Pharmacol.

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“…Riippi et al (1998) performed the friability test on erythromycin acistrate tablets using a friabilator for 100 rotations. Ameye et al (2002) performed the friability test on tablets formed using granulated powder formulation. They used Pharma Test-type friabilator at 25 rpm for 4 min (100 rotations).…”

Section: Determination Of Tablet Quality Parametersmentioning

confidence: 99%

Feasibility of Relationships between Tablet Physical Quality Parameters and Mechanical Properties of Dry Powder Formulation

Pandeya

Puri

2013

KONA

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confidence: 99%

“…3) Because of the similar structure design to the pilot and production equipments, lab-scale machines are supposed to provide useful information for subsequent granulation in large scale machines of the same type and it is believed that this information will facilitate subsequent large-scale processing. 4,5) High shear granulation is a multivariate process and the product properties are sensitive to changes in the process variables such as impeller speed, chopper speed and kneading time hence it is important to work out the effects of these critical parameters. 2,4,[6][7][8] The microcrystalline cellulosebased (MCC-based) system and starch-based system are two main material systems used for high shear granulation; however, researchers usually chose one of the two systems for their investigations.…”

mentioning

confidence: 99%

“…4,5) High shear granulation is a multivariate process and the product properties are sensitive to changes in the process variables such as impeller speed, chopper speed and kneading time hence it is important to work out the effects of these critical parameters. 2,4,[6][7][8] The microcrystalline cellulosebased (MCC-based) system and starch-based system are two main material systems used for high shear granulation; however, researchers usually chose one of the two systems for their investigations. 5,9) Because of the popularity of these two systems and the difficulty in scaling up the process, comparison of the high shear granulating process with the two systems mentioned using lab-scale equipment that is representative of large-scale circumstances is necessary for the application of this technique.…”

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confidence: 99%

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Investigation of High Shear Wet Granulation Processes Using Different Parameters and Formulations

Wang

Heng

et al. 2008

CHEMICAL & PHARMACEUTICAL BULLETIN

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High shear mixers have been widely used in the pharmaceutical industry. There are several advantages of granulation in a high shear mixer: a shorter processing time; a need for less liquid binders compared with fluid bed granulators and, thus, a shorter drying process is obtained; voluminous materials can be densified. Moreover, granulation is performed in a closed system, which can include drying (microwave or vacuum); the porosity of the product can be influenced by the massing time and impact of the impeller; cleaning operations can be carried out easily either manually or by a clean-inplace system. 1) Different phases of growth were identified for high shear granulation: nucleation, fragmentation, densification, exponential growth due to coalescence, and break up. 2)Scale-up of the wet granulation processes from laboratory scale to pilot and production scale is problematic. Even within the same manufacture of machine, liquid requirement and granule properties in terms of granule size distribution and granule porosity might change by scaling-up due to the difference space and impact force between large-scale and small-scale machines. However, in many situations, pharmaceutical researchers have to deal with a shortage of active substances and granulation materials. In order to develop a formulation and study the process effectively, laboratoryscale equipment is used during the early stages of research. 3)Because of the similar structure design to the pilot and production equipments, lab-scale machines are supposed to provide useful information for subsequent granulation in large scale machines of the same type and it is believed that this information will facilitate subsequent large-scale processing. 4,5) High shear granulation is a multivariate process and the product properties are sensitive to changes in the process variables such as impeller speed, chopper speed and kneading time hence it is important to work out the effects of these critical parameters.2,4,6-8) The microcrystalline cellulosebased (MCC-based) system and starch-based system are two main material systems used for high shear granulation; however, researchers usually chose one of the two systems for their investigations. 5,9) Because of the popularity of these two systems and the difficulty in scaling up the process, comparison of the high shear granulating process with the two systems mentioned using lab-scale equipment that is representative of large-scale circumstances is necessary for the application of this technique. In addition, it has been found that the toroidal motion of the wet mass during the granulating process could have marked impact on the product properties and the reproducibility of the manufacturing process. 10)However, few studies report the possibility of maintaining this flow pattern of wet mass by adjusting the process parameters and the raw material.The aims of present study are to compare the manufacturing process for the two main material systems used for high shear granulation and to try to obtain information about p...

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Scaling-up of a lactose wet granulation process in Mi-Pro high shear mixers

Cited by 42 publications

References 5 publications

Efficacious formulation of anti-malarial dry suspension for pediatric use

Efficacious formulation of anti-malarial dry suspension for pediatric use

Feasibility of Relationships between Tablet Physical Quality Parameters and Mechanical Properties of Dry Powder Formulation

Investigation of High Shear Wet Granulation Processes Using Different Parameters and Formulations

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