Characterization of Powder- and Tablet Properties of Different Direct Compaction Grades of Mannitol Using a Kohonen Self-organizing Map and a Lasso Regression Model

Kosugi, Atsushi; Leong, Kok Hoong; Tsuji, Hinako; Hayashi, Yoshihiro; Kumada, Shungo; Okada, Kotaro; Onuki, Yoshinori

doi:10.1016/j.xphs.2020.05.010

Cited by 11 publications

(9 citation statements)

References 20 publications

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“…Similarly, Wagner et al investigated the compactability of five different spray-dried mannitol grades [8]. Recently, we also investigated the powder properties of 15 different commercial DC grades of mannitol [9]. In the course of our study, a wide range of powder and tablet properties concerning the different grades were examined: the variables to be examined were the powder properties representing flowability, size, shape, and manufacturing properties, and tablet properties including disintegration time (DT), friability, and tensile strength (TS).…”

Section: Introductionmentioning

confidence: 93%

“…Purified water at 37 ± 0.5 • C was employed as the test medium. A detailed explanation of this apparatus has been given elsewhere [9]. In short, a test tablet was placed on a stainless-steel plate having many small holes in a regular pattern and the bottom surface of the plate was faced with the test medium filled in the vessel.…”

Section: Disintegration Timementioning

confidence: 99%

“…We further characterized the powder and tablet properties of the clusters. We have previously measured various powder properties of the test mannitol grades [9]. This study used the following six powder properties: bulk density (V bulk ), compressibility index (CI), angle of repose (AR), median diameter of particle size (D50), specific surface area (SSA), and ejection stress (ES).…”

Section: Relationships Of Powder Properties Of Mannitol Grades With Tmentioning

confidence: 99%

“…The TS data were acquired from the model tablets prepared at a compression force of 5 kN, while those of friability and DT, compression force (kN) were from the model tablets with 65 N of hardness. The data of powder properties including V bulk , CI, AR, D50, SSA, DS, and ES are quoted from the previous study [9]. ** p < 0.01 and * p < 0.05 vs. the entire data.…”

Section: Relationships Of Powder Properties Of Mannitol Grades With Tmentioning

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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Section: Introductionmentioning

confidence: 93%

Section: Disintegration Timementioning

confidence: 99%

Section: Relationships Of Powder Properties Of Mannitol Grades With Tmentioning

confidence: 99%

Section: Relationships Of Powder Properties Of Mannitol Grades With Tmentioning

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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“…Also, it is not hygroscopic, although very soluble in water, thus offering excellent stability and compatibility with drugs [69]. Spray-dried mannitol is commercially available in two grades: the 100 or EZ and 200 or XL with the former having smaller mean particle size [70]. Unlike lactose, spray drying does not affect its crystallinity with the final product being comprised of β crystals (Parteck ® ) or a mixture of α and β mannitol crystals (Pearlitol ® , and Mannogem ® ) [71,72].…”

Section: Spray-dried Sugars and Polyolsmentioning

confidence: 99%

Spray Drying for Direct Compression of Pharmaceuticals

et al. 2021

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Tableting by direct compression (DC) is one of the simplest and most cost-effective drug manufacturing approaches. However, most active pharmaceutical ingredients (APIs) and excipients lack the compression and flow properties required to meet the needs of high-speed industrial tablet presses. Therefore, the majority of DC APIs and excipients are modified via processing/co-processing particle engineering techniques to boost their properties. Spray drying is one of the most commonly employed techniques to prepare DC grades of APIs and excipients with prominent advantages. This review aims to present an overview of the commercially marketed and investigationally-prepared DC APIs and excipients produced by spray drying.

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