Estimation of capping incidence by indentation fracture tests

Kuppuswamy, Ramesh; Anderson, Sheree; Augsburger, Larry L.; Hoag, Stephen W.

doi:10.1208/ps030105

Cited by 13 publications

(11 citation statements)

References 16 publications

(12 reference statements)

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“…As an effort to mitigate this issue, Akseli et al (2014) presents a relationship between capping and process parameters including formulations. In addition, Kuppuswamy et al (2001)'s study is an attempt to predict the risk of capping by indentation hardness and observe crack development. Kuppuswamy et al (2001) investigated detection of formula prone to capping using indentation hardness test attributing capping to the residual die-wall pressure introducing microscopic cracks, which is hypothesized to develop into cracks, therefore capping due to insufficient plasticity.…”

Section: Quality: Mechanical Defectsmentioning

confidence: 99%

“…In addition, Kuppuswamy et al (2001)'s study is an attempt to predict the risk of capping by indentation hardness and observe crack development. Kuppuswamy et al (2001) investigated detection of formula prone to capping using indentation hardness test attributing capping to the residual die-wall pressure introducing microscopic cracks, which is hypothesized to develop into cracks, therefore capping due to insufficient plasticity. This study suggests that the plasticity of particles is related to localized defect development.…”

Section: Quality: Mechanical Defectsmentioning

confidence: 99%

“…Accordingly, many studies used the indentation hardness as a characterization method of mechanical properties of compacts (Bonaccorsi and Proverbio, 2006;Chtourou et al, 2002;Kuppuswamy et al, 2001;Tehrani et al, 2010) as well as an evaluation metrics of a compaction process (Chtourou et al, 2002).…”

Section: Quality: Hardnessmentioning

confidence: 99%

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Critical Review on Engineering Mechanical Quality of Green Compacts using Powder Properties

Pandeya²,

Karamchandani

et al. 2018

KONA

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For processes involving particulate materials, mechanical properties of green compacts are of great interest when they are final or intermediate products. Optimal quality of green compacts is achieved usually with empirical approaches, i.e., unexpected issues in processes or products' quality are usually mitigated by time and resource consuming trial-and-error methods. Issues of the powder compaction are commonly observed when there are problems in feed materials or operational conditions even without any substantial change in a formula. Such divergent behavior of particulate materials is especially problematic for product developments and reliable operations. It has been widely accepted hypothesis that properties of particles are determinants of mechanical behavior of powder during compaction and the quality of resulting compacts. With recent developments in nanotechnology, characterization and engineering of individual particles at a microscopic or sub-microscopic scale are now feasible. Leveraging recent technological advancements, there has been a good progress in regard to quantitative understanding of mechanical relationships between properties of particles, particle system and final product. This review highlights the recent developments and gaps in engineering mechanical quality of powder compacts in conjunction with the characterization of particle systems and compaction at multiple scales.

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Section: Quality: Mechanical Defectsmentioning

confidence: 99%

Section: Quality: Mechanical Defectsmentioning

confidence: 99%

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Critical Review on Engineering Mechanical Quality of Green Compacts using Powder Properties

Pandeya²,

Karamchandani

et al. 2018

KONA

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“…The procedure was as follows: (1) the stress relaxation test was preliminarily conducted before tableting under the same compression conditions used in the tableting, (2) a tablet was then prepared while monitoring the force-displacement curve and the decompression time, (3) the E p were calculated from the force-displacement curve, (4) the decompression time in the tableting was considered as the relaxation time t in Eq. (2), and the Y(t) was estimated from the result of the stress relaxation test, and (5) the E b (t) were estimated by Eq. (3).…”

Section: Applicability Of the E E -E P Diagram To The Doublecompressimentioning

confidence: 99%

“…An indentation fracture test 2) has been proposed as an out-of-die evaluation method, in which the capping tendency was evaluated by making a small indentation fracture on the tablet. An X-ray microtomography, 3,4) by which cracks inside a tablet can be directly visualized noninvasively, has also been employed as an out-of-die evaluation method.…”

mentioning

confidence: 99%

In-Die Evaluation of Capping Tendency of Pharmaceutical Tablets Using Force-Displacement Curve and Stress Relaxation Parameter

Nakamura

Sugino

Watano

2012

CHEMICAL & PHARMACEUTICAL BULLETIN

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A novel in-die evaluation method of tablet capping tendency was proposed based on a force-displacement curve and stress relaxation parameter in a tableting process. In our previous study (Chem. Pharm. Bull., 59, 2011, Nakamura et al.), the phase diagram consisting of elastic recovery energy (E e ) and plastic deformation energy (E p ) of compressed powder, named as the E e -E p diagram, was proposed. However, it was found that capping tendency of tablets prepared by double-compression with multi-component powder formulations cannot be discriminated using the E e -E p diagram. To improve the capping discrimination ability, we here proposed a novel corrected phase diagram consisting of the E e and an interparticle bonding parameter E b (t), named as the E e -E b (t) diagram. The E b (t) was proposed as a new parameter expressing strength of the interparticle bonding formed by the stress relaxation inside compressed powder. The E b (t) was defined as a product of the E p and the stress relaxation parameter Y(t), estimated from the force-displacement curve and the stress relaxation test. The capping discrimination ability of the diagrams was evaluated using a hierarchical-clustering analysis. The results exhibited that the capping tendency could be clearly discriminated using the proposed E e -E b (t) diagram at the double-compression and the multi-component powder formulations, as compared to the E e -E p diagram. This proposed diagram can be used for screening of the powder formulations to avoid the capping.Key words tableting; capping; stress relaxation; force-displacement curve; hierarchical-clustering analysis When pharmaceutical powders are compressed into tablets, cracking or lamination sometimes occurs inside the tablets. This phenomenon is well known as capping. The capping is one of the most common tableting troubles. Although many efforts have been made to overcome the trouble, the capping has still been an unsolved issue. Thus, a methodology to evaluate and avoid the capping has been a strong interest in pharmaceutical industries.Generally, capping tendency can be evaluated by out-ofdie or in-die evaluation methods. In the out-of-die evaluation methods the capping tendency is evaluated after ejection of the tablet from a die, whereas in the in-die evaluation methods the capping tendency is evaluated during preparation of the tablet.As an out-of-die evaluation method of the capping tendency, visual inspection after a friability test 1) is widely accepted. An indentation fracture test 2) has been proposed as an out-of-die evaluation method, in which the capping tendency was evaluated by making a small indentation fracture on the tablet. An X-ray microtomography, 3,4) by which cracks inside a tablet can be directly visualized noninvasively, has also been employed as an out-of-die evaluation method. However, the out-of-die evaluation methods are cumbersome, because they need to handle tablets after their preparation.By contrast, in-die evaluation methods can evaluate the capping tendency using data monitored...

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Quantitative Correlation of the Effect of Process Conditions on the Capping Tendencies of Tablet Formulations

Akseli

Stecuła

et al. 2014

Journal of Pharmaceutical Sciences

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Estimation of capping incidence by indentation fracture tests

Cited by 13 publications

References 16 publications

Critical Review on Engineering Mechanical Quality of Green Compacts using Powder Properties

Critical Review on Engineering Mechanical Quality of Green Compacts using Powder Properties

In-Die Evaluation of Capping Tendency of Pharmaceutical Tablets Using Force-Displacement Curve and Stress Relaxation Parameter

Quantitative Correlation of the Effect of Process Conditions on the Capping Tendencies of Tablet Formulations

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