High-shear granulation of high-molecular weight hypromellose: effects of scale-up and process parameters on flow and compaction properties

Grdešič, Peter; Sovány, Tamás; Ilić, Ilija

doi:10.1080/03639045.2018.1496447

Cited by 8 publications

(6 citation statements)

References 32 publications

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“…Next, the median granule size G 50 as the critical quality attribute must be measured and given, since the granule size had a significant impact on the subsequent processes (e.g. tableting) as well as the final product quality 29 . As a result, 10 articles were found to fit for the above requirements, and 143 pieces of experimental data were successfully extracted.…”

Section: Methodsmentioning

confidence: 99%

Using a material database and data fusion method to accelerate the process model development of high shear wet granulation

Wang

Cao

et al. 2021

Sci Rep

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High shear wet granulation (HSWG) has been wildly used in manufacturing of oral solid dosage (OSD) forms, and process modeling is vital to understanding and controlling this complex process. In this paper, data fusion and multivariate modeling technique were applied to develop a formulation-process-quality model for HSWG process. The HSWG experimental data from both literature and the authors’ laboratory were fused into a single and formatted representation. A material database and material matching method were used to compensate the incomplete physical characterization of literature formulation materials, and dimensionless parameters were utilized to reconstruct process variables at different granulator scales. The exploratory study on input materials properties by principal component analysis (PCA) revealed that the formulation data collected from different articles generated a formulation library which was full of diversity. In prediction of the median granule size, the partial least squares (PLS) regression models derived from literature data only and a combination of literature data and laboratory data were compared. The results demonstrated that incorporating a small number of laboratory data into the multivariate calibration model could help significantly reduce the prediction error, especially at low level of liquid to solid ratio. The proposed data fusion methodology was beneficial to scientific development of HSWG formulation and process, with potential advantages of saving both experimental time and cost.

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Section: Methodsmentioning

confidence: 99%

Using a material database and data fusion method to accelerate the process model development of high shear wet granulation

Wang

Cao

et al. 2021

Sci Rep

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“…These results are per the flow time test, so it can be concluded that the runs with the best flow properties are runs 2 and 6. This is because the HPMC K100M has an irregular shape [23]. Irregular shapes can enlarge the space in the compression chamber so that the reduced volume will be even greater.…”

Section: Physical Properties Of Creatine Monohydrate's Floating Tabletmentioning

confidence: 99%

The Development of Alternative Dosage Form for Creatine Monohydrate: A Floating Tablet

Nur Hidayah,

Ardiana Wati,

Yuniarti

et al. 2023

J. Food Pharm. Sci

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Creatine monohydrate has been developed as a neuroprotective agent and can penetrate in vitro model of the blood-brain barrier. However, its delivery is hampered by its limited capacity of creatine transporter. The floating system is known to increase the residence time of drugs in the stomach; thus, the active substances can be absorbed more optimally. Therefore, this study is aimed to develop creatine monohydrate floating tablets by optimizing the proportion of HPMC K100M and NaHCO2 and evaluating the quality of floating tablets. The formula was designed Simplex Lattice Design method. Tablets were prepared by the wet granulation method and evaluated for granule and tablet parameters. The results showed that HPMC K100M significantly increased flow time, absorption rate, hardness, floating time, swelling index; decreased index tap, fragility, and floating lag time. Meanwhile, an increase in NaHCO2 significantly affects an increase in floating lag time. The optimum formula obtained was 18.87% HPMC K100M and 21.12% NaHCO2. Verification of the optimum formula showed that tablet parameters were not significantly different from the predicted formula. The studies suggest that this prototype can be developed to increase creatine residence time in the stomach.

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“…This is consistent with the other reports. [21][22][23] Further, the degree of owability improvement via these two types of processing techniques was nearly equal. Moreover, the particle size and size distribution of acidic and/or alkaline granules aer uid-bed coating were 2-3fold larger and more uniform than only those via high-shear wet granulation (e.g., citric acid granules; D 0.5 : 158.84-240.92 vs. 72.78 mm; Span: 1.51-1.72 vs. 2.63), which was in accordance with the SEM results.…”

Section: Surface Morphology and Powder Propertiesmentioning

confidence: 99%

Improvements in sticking, hygroscopicity, and compactibility of effervescent systems by fluid-bed coating

Zheng

Yang

et al. 2019

RSC Adv.

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High-shear granulation of high-molecular weight hypromellose: effects of scale-up and process parameters on flow and compaction properties

Cited by 8 publications

References 32 publications

Using a material database and data fusion method to accelerate the process model development of high shear wet granulation

Using a material database and data fusion method to accelerate the process model development of high shear wet granulation

The Development of Alternative Dosage Form for Creatine Monohydrate: A Floating Tablet

Improvements in sticking, hygroscopicity, and compactibility of effervescent systems by fluid-bed coating

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