Effect of particle size distribution on flowability of granulated lactose

Kudo, Yozo; Yasuda, Masatoshi; Matsusaka, Shuji

doi:10.1016/j.apt.2019.10.004

Cited by 58 publications

(18 citation statements)

References 25 publications

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“…Generally, small particles show poor flowability but good compressibility [13]. The result, however, shows that both Journal of Nanomaterials the tablet hardness and the particle size of the agglomerated lactose increase at the same time (Figure 4) for the following possible reason.…”

Section: Resultsmentioning

confidence: 96%

Fabrication of Agglomerated Lactose Using Fluidized Bed for Good Compressibility

Wang

Xiang

et al. 2021

Journal of Nanomaterials

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In this work, a fluidized bed agglomeration process was used to produce agglomerated lactose with good compressibility. In the fluidized bed agglomeration, large lactose crystals were used as the core materials, fine-milled lactose particles were bound to the surface of large lactose cores, and lactose solution was used as the binder. A suspension of lactose solution is sprayed onto the fluidized lactose particles, forming liquid bridges among the large and small lactose particles to form agglomerated lactose. Good hardness of 75-88 N was achieved for the agglomerated lactose. The particle size and bulk density can be controlled. The effects of agglomeration parameters, including solution concentration and temperature, atomizing pressure, peristalsis speed, and material temperature, were investigated for the agglomeration result and the characteristics of the agglomerated lactose. The result also shows that high solution temperature and high solution concentration can improve fluidized bed agglomeration efficiency.

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Section: Resultsmentioning

confidence: 96%

Fabrication of Agglomerated Lactose Using Fluidized Bed for Good Compressibility

Wang

Xiang

et al. 2021

Journal of Nanomaterials

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“…The flow of powder during die filling, one of the crucial steps in the manufacturing of tablets, can affect not only the overall efficiency of the tableting process, but also the final product quality, such as weight and content uniformity [ 26 , 27 ]. The flowability of powders used in the manufacturing of tablets has a significant impact on the uniformity of tablet weight and drug content [ 28 ]. The angle of repose is an important test for determining the flowability of powders and granules [ 19 ].…”

Section: Resultsmentioning

confidence: 99%

Design Space Approach for the Optimization of Green Fluidized Bed Granulation Process in the Granulation of a Poorly Water-Soluble Fenofibrate Using Design of Experiment

et al. 2022

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In the pharmaceutical industry, the systematic optimization of process variables using a quality-by-design (QbD) approach is highly precise, economic and ensures product quality. The current research presents the implementation of a design-of-experiment (DoE) driven QbD approach for the optimization of key process variables of the green fluidized bed granulation (GFBG) process. A 32 full-factorial design was performed to explore the effect of water amount (X1; 1–6% w/w) and spray rate (X2; 2–8 g/min) as key process variables on critical quality attributes (CQAs) of granules and tablets. Regression analysis have demonstrated that changing the levels of X1 and X2 significantly affect (p ≤ 0.05) the CQAs of granules and tablets. Particularly, X1 was found to have the pronounced effect on the CQAs. The GFBG process was optimized, and a design space (DS) was built using numerical optimization. It was found that X1 and X2 at high (5.69% w/w) and low (2 g/min) levels, respectively, demonstrated the optimum operating conditions. By optimizing X1 and X2, GFBG could enhance the disintegration and dissolution of tablets containing a poorly water-soluble drug. The prediction error values of dependent responses were less than 5% that confirm validity, robustness and accuracy of the generated DS in optimization of GFBG.

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“…Good flowability of powders can be essential for further processing, to ensure, for example, a homogenous blending process and reproducible filling of the die during tableting. Different product attributes, such as residual moisture (1, 2), particle size distribution (3)(4)(5), particle morphology (4,5) and electrostatic charging (6,7) can affect the flowability of powders. Many drugs form needles or other poorly flowing crystal structures, so that further processing, like granulation or spray-drying, or the addition of glidants is required to produce a free-flowing powder.…”

Section: Introductionmentioning

confidence: 99%

Towards a better understanding of the role of stabilizers in QESD crystallizations

Hansen

Kleinebudde

2022

Pharm Res

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Quasi-emulsion solvent-diffusion crystallization (QESD) is a type of spherical crystallization which can be used as a particle design method to improve the flowability and micromeritic properties of drugs or excipients. Spherical particles are generated by dispersing a solvent phase in an antisolvent so that a transient emulsion is formed. Within the droplets the material can crystallize and agglomerate into spherical, hollow particles. Surfactants, such as surface-active polymers like hypromellose, are often required to stabilize the quasi-emulsion. To gain further understanding for the role of the stabilizer, a new screening-method was developed which compared different surface active polymers in solution at similar dynamic viscosities rather than at a set concentration. The dynamic viscosities of a low-viscosity grade hypromellose solution used in the previous publications describing the QESD crystallization of metformin hydrochloride by the authors was used as a target value. QESD crystallizations of metformin hydrochloride (MF) and celecoxib showed that the type of stabilizer and whether it is dissolved in the solvent or antisolvent has an effect on the agglomerates. For MF, the type of hypromellose used can have a significant influence on the properties of the agglomerates. More polymers could be used to stabilize the transient emulsion of celecoxib than previously found in literature. Furthermore, QESD crystallizations seem to be more robust when the stabilizer is dissolved in the antisolvent, however this can lead to a reduced drug load of the agglomerates.

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Effect of particle size distribution on flowability of granulated lactose

Cited by 58 publications

References 25 publications

Fabrication of Agglomerated Lactose Using Fluidized Bed for Good Compressibility

Fabrication of Agglomerated Lactose Using Fluidized Bed for Good Compressibility

Design Space Approach for the Optimization of Green Fluidized Bed Granulation Process in the Granulation of a Poorly Water-Soluble Fenofibrate Using Design of Experiment

Towards a better understanding of the role of stabilizers in QESD crystallizations

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