Roles of Granule Size in Over-Granulation During High Shear Wet Granulation

Shi, Limin; Feng, Yushi; Sun, Changquan Calvin

doi:10.1002/jps.22118

Cited by 48 publications

(39 citation statements)

References 16 publications

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“…Since tablets with tensile strength >2 MPa can be made using all four batches of HPC-coated ACM powders (Fig. 6), their tabletability is considered excellent (37). Coated ACM powders are therefore suitable for being used in a direct compression process in terms of powder tabletability.…”

Section: Tableting Performancementioning

confidence: 99%

Overcoming Poor Tabletability of Pharmaceutical Crystals by Surface Modification

Shi

Sun

2011

Pharm Res

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Section: Tableting Performancementioning

confidence: 99%

Overcoming Poor Tabletability of Pharmaceutical Crystals by Surface Modification

Shi

Sun

2011

Pharm Res

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“…4b, the roundness was positively correlated with the water content, d 50 was positively correlated with the uniformity coefficient, the compressibility was positively correlated with the angle of repose, and the proportion of fine particles (106-212 µm) was positively correlated with Carr's index. Interestingly, Shi et al 16) reported that increases in the amount of water added during the granulation process led to a change in the shape of granules from being elongated to being round in shape, suggesting that the raw material must be sufficiently wetted to obtain fine globular granules. On the contrary, roundness was negatively correlated with the compressibility and angle of repose.…”

Section: )mentioning

confidence: 99%

Evaluation of the Physicochemical Properties of Fine Globular Granules Prepared by a Multi-functional Rotor Processor

Kimura

Iwao

Ishida

et al. 2014

CHEMICAL & PHARMACEUTICAL BULLETIN

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Multiple regression analysis (MRA) and principal component analysis (PCA) have been used in the present study to examine the relationships between the operational conditions of a unique multi-functional rotor processor, material attributes such as water content during granulation, and a series of associated micromeritics, including the flowability, granule mean size and granule density values. A variety of different operational conditions were tested, including the binder flow rate, atomization pressure, slit air flow rate, rotating speed and temperature of the inlet air. The results of MRA revealed several trends, including (1) the granule mean size was negatively affected by the atomization pressure, and positively affected by the binder flow rate; (2) the granule flow property, Carr's index was positively affected by the atomization pressure, and negatively affected by the slit air flow rate; and (3) the granule density was positively affected by the rotating speed. Taken together, these results suggested that the binder flow rate, atomization pressure and slit airflow rate were critical process parameters for the preparation of fine globular granules. Using PCA, it was possible to examine each relationship of all 19 batches and 10 variables, as well as determine which process parameters or material attributes impacted on the quality of the final product. The PCA results revealed that the roundness was positively correlated with the water content. Therefore, we believe this fundamental information will be important for the development of processes for the facile manufacture of fine globular granules.Key words fine globular granule; flowability; experimental design; multiple regression analysis; multivariate data analysis A large number of functional granules have been developed by the pharmaceutical industry, including granules with sustained release, delayed release, and taste-masking properties. During the coating process in order to add the functionality of granules, if the granules are spheronized, uniform coating of the active ingredient becomes possible, 1) and the solubility behavior can be easily estimated using numerical equations such as Noyes-Whiteny's Equation and Hixson-Crowell's Cube Root Equation.2) The manufacturing processes associated with the preparation of spherical granules are therefore of critical importance.Extrusion-spheronization, centrifugal granulation, and fluidized bed rotogranulation have been applied as manufacturing processes for the preparation of spherical granules. 3-5)Extrusion-spheronization and centrifugal granulation generally require long operation times, and the material handling procedures associated with these processes are considered to be particularly complicated. Fluidized bed rotogranulation frequently leads to particle aggregation, suggesting that the granule mean sizes of the resulting particles are larger than the value required for the desired product. 6)Furthermore, for particles less than 100 µm in size, the application of a uniform film coating process be...

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“…The dispersibility of a powder in a liquid is related to its cohesiveness (McGinity et al, 1985). A decrease in cohesive forces between particles facilitates de-agglomeration (Shi et al, 2010) and has been reported to enhance drug dissolution (Qu et al, 2014;Tay et al, 2012). For poorly water-soluble drugs, attempts have been made to enhance their rate of dissolution by increasing the surface area of the drug through micronization (Bolhuis et al, 1997).…”

Section: Introductionmentioning

confidence: 99%

“…For example, powder free-flowing from a hopper under gravity is generally required to facilitate uniform and efficient die-filling during high-speed tablet manufacturing (Shi et al, 2010). The dispersibility of a powder in a liquid is related to its cohesiveness (McGinity et al, 1985).…”

Section: Introductionmentioning

confidence: 99%

Influence of coating material on the flowability and dissolution of dry-coated fine ibuprofen powders

Zhou

Denman

et al. 2015

European Journal of Pharmaceutical Sciences

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Roles of Granule Size in Over-Granulation During High Shear Wet Granulation

Cited by 48 publications

References 16 publications

Overcoming Poor Tabletability of Pharmaceutical Crystals by Surface Modification

Overcoming Poor Tabletability of Pharmaceutical Crystals by Surface Modification

Evaluation of the Physicochemical Properties of Fine Globular Granules Prepared by a Multi-functional Rotor Processor

Influence of coating material on the flowability and dissolution of dry-coated fine ibuprofen powders

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