Comparative analyses of flow and compaction properties of diverse mannitol and lactose grades

Paul, Shubhajit; Chang, Shao Yu; Dun, Jiangnan; Sun, Wenjuan; Wang, Kunlin; Tajarobi, Pirjo; Boissier, Catherine; Sun, Changquan Calvin

doi:10.1016/j.ijpharm.2018.04.058

Cited by 43 publications

(30 citation statements)

References 58 publications

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“…The three types of mannitol powders, used in respective comparison with the three lactose powders, were milled crystalline mannitol (Pearlitol 50C) (β-mannitol [ 23 ]), spray-dried mannitol (Pearlitol 200SD) (known to contain both α- and β-mannitol [ 24 ] and is crystalline [ 25 ]), and granulated mannitol (Pearlitol 300DC) (β-mannitol [ 8 , 23 ]). All mannitol powders were supplied by Roquette (Lestrem cedex, France).…”

Section: Methodsmentioning

confidence: 99%

Twin Screw Granulation: Effects of Properties of Primary Powders

2018

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Lactose and mannitol are some of the most commonly used powders in the pharmaceutical industry. The limited research published so far highlights the effects of process and formulation parameters on the properties of the granules and the tablets produced using these two types of powders separately. However, the comparison of the performance of these two types of powders during twin screw wet granulation has received no attention. The present research is focused on understanding the granulation mechanism of different grades of two pharmaceutical powders with varying properties (i.e., primary particle size, structure, and compressibility). Three grades each of lactose and mannitol were granulated at varying liquid to solid ratios (L/S) and screw speed. It was noticed that primary powder morphology plays an important role in determining the granule size and structure, and tablet tensile strength. It was indicated that the processed powders such as spray-dried and granulated lactose and mannitol can be used in formulation for wet granulation where flowability of active pharmaceutical ingredient (API) is poor.

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Section: Methodsmentioning

confidence: 99%

Twin Screw Granulation: Effects of Properties of Primary Powders

2018

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“…These properties are advantageous for a tablet filler, especially orally disintegrating tablets (ODTs). Furthermore, mannitol is more chemically inert than lactose, because mannitol is not accompanied by the Maillard reaction, which can occur between lactose and amine functional groups, in APIs, which leads to their degradation [4,5]. Thus, it can be used as an alternative filler to lactose.…”

Section: Introductionmentioning

confidence: 99%

“…As far as direct compression (DC) grade is concerned, there are various commercial grades. Each grade possesses different powder properties [4,6,7], which substantially affects the production and quality of the tablet products in a complex manner. Therefore, a comprehensive understanding of the effects of the different commercial grades on the properties of the resulting tablet has been very important for designing tablet formulations.…”

Section: Introductionmentioning

confidence: 99%

“…Therefore, a comprehensive understanding of the effects of the different commercial grades on the properties of the resulting tablet has been very important for designing tablet formulations. Several researchers have investigated different mannitol grades in terms of the characterization of powder properties and the effect on tablet properties [4,6,8]. For example, Paul et al examined 11 different grades of mannitol in terms of relationships between the powder properties (e.g., particle size, surface area, plasticity) and tableting performance (e.g., tensile strength of the resulting tablets) [4,6].…”

Section: Introductionmentioning

confidence: 99%

“…Several researchers have investigated different mannitol grades in terms of the characterization of powder properties and the effect on tablet properties [4,6,8]. For example, Paul et al examined 11 different grades of mannitol in terms of relationships between the powder properties (e.g., particle size, surface area, plasticity) and tableting performance (e.g., tensile strength of the resulting tablets) [4,6]. Similarly, Wagner et al investigated the compactability of five different spray-dried mannitol grades [8].…”

Section: Introductionmentioning

confidence: 99%

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Effect of Different Direct Compaction Grades of Mannitol on the Storage Stability of Tablet Properties Investigated Using a Kohonen Self-Organizing Map and Elastic Net Regression Model

et al. 2020

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This study tested 15 direct compaction grades to identify the contribution of different grades of mannitol to the storage stability of the resulting tablets. After preparing the model tablets with different values of hardness, they were stored at 25 °C, 75% relative humidity for 1 week. Then, measurement of the tablet properties was conducted on both pre- and post-storage tablets. The tablet properties were tensile strength (TS), friability, and disintegration time (DT). The experimental data were analyzed using a Kohonen self-organizing map (SOM). The SOM analysis successfully classified the test grades into three distinct clusters having different changes in the behavior of the tablet properties accompanying storage. Cluster 1 showed an obvious rise in DT induced by storage, while cluster 3 showed a substantial change in mechanical strength of the tablet including a reduction in the TS and a rise in friability. Furthermore, the data were analyzed using an Elastic net regression technique to investigate the general relationships between the powder properties of mannitol and the change behavior of the tablet properties. Consequently, we succeeded in identifying the crucial powder properties for the storage stability of the resulting tablets. This study provides advanced technical knowledge to characterize the effect of different direct compaction grades of mannitol on the storage stability of tablet properties.

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Practical Determination of Flow Properties

Schulze

2021

Powders and Bulk Solids

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Comparative analyses of flow and compaction properties of diverse mannitol and lactose grades

Cited by 43 publications

References 58 publications

Twin Screw Granulation: Effects of Properties of Primary Powders

Twin Screw Granulation: Effects of Properties of Primary Powders

Effect of Different Direct Compaction Grades of Mannitol on the Storage Stability of Tablet Properties Investigated Using a Kohonen Self-Organizing Map and Elastic Net Regression Model

Practical Determination of Flow Properties

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