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

Akseli, Ilgaz; Stecuła, Adrian; He, Xiaorong; Ladyzhynsky, Nadia

doi:10.1002/jps.23951

Cited by 27 publications

(8 citation statements)

References 18 publications

(55 reference statements)

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“…The following parameters were identified: weight, 16 diameter, 17 thickness, 16,17 compression force, [18][19][20] tablet porosity, 17,18 tablet compression speed, 21,22 and speed of sound in the tablets in the radial direction. 23,24 These parameters could have either direct or indirect impact on the tablet breaking force and disintegration time. Meanwhile, as this work is targeted to establish a practical framework that can be adapted to more specific applications, we avoided factors that are very formulation dependent and thus hard to be generalized, such as disintegrant, lubricant, and binder, and so forth.…”

Section: Selection Of Input Variables To Modelsmentioning

confidence: 99%

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A Practical Framework Toward Prediction of Breaking Force and Disintegration of Tablet Formulations Using Machine Learning Tools

Akseli

Xie

Schultz

et al. 2017

Journal of Pharmaceutical Sciences

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Enabling the paradigm of quality by design requires the ability to quantitatively correlate material properties and process variables to measureable product performance attributes. Conventional, quality-by-test methods for determining tablet breaking force and disintegration time usually involve destructive tests, which consume significant amount of time and labor and provide limited information. Recent advances in material characterization, statistical analysis, and machine learning have provided multiple tools that have the potential to develop nondestructive, fast, and accurate approaches in drug product development. In this work, a methodology to predict the breaking force and disintegration time of tablet formulations using nondestructive ultrasonics and machine learning tools was developed. The input variables to the model include intrinsic properties of formulation and extrinsic process variables influencing the tablet during manufacturing. The model has been applied to predict breaking force and disintegration time using small quantities of active pharmaceutical ingredient and prototype formulation designs. The novel approach presented is a step forward toward rational design of a robust drug product based on insight into the performance of common materials during formulation and process development. It may also help expedite drug product development timeline and reduce active pharmaceutical ingredient usage while improving efficiency of the overall process.

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Section: Selection Of Input Variables To Modelsmentioning

confidence: 99%

“…There has been an established rough correlation between Young's modulus and tablet breaking force, which states that the tablet breaking force is proportional to the Young's modulus. 24,25 In this way, radial speed of sound can be used to indirectly reflect the breaking force of the tablet.…”

Section: Radial Speed Of Soundmentioning

confidence: 99%

A Practical Framework Toward Prediction of Breaking Force and Disintegration of Tablet Formulations Using Machine Learning Tools

Akseli

Xie

Schultz

et al. 2017

Journal of Pharmaceutical Sciences

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“…As mentioned above, because the mechanical properties of the tablet are density dependent, the differences in density distribution imply the different distribution of the mechanical properties in these two differently shaped types of tablets, which may have effects on the fracture process during diametrical compression. Akseli et al (2013Akseli et al ( , 2014) measured a ratio of Young's modulus in axial and radial directions of tablets using ultrasonic technique and they found that as the ratio deviated from unity, tablets expected to be more heterogeneous and this approach revealed that heterogeneities in the tablet lead to capping. In our research, double-radius tablet has more heterogeneous density than single-radius tablet as described in Fig.…”

Section: Fem Results Of the Tablet Thickness And The Density Distribumentioning

confidence: 97%

“…Capping typically occurs during compression, unloading or ejection from the die and subsequent coating and packaging, or physical testing (Akseli et al, 2014). It will be highly desired if one can know the changes of mechanical properties or mechanical state under the loading conditions and the correlations between these changes inside the tablet and capping.…”

Section: Introductionmentioning

confidence: 99%

Numerical evaluation of the capping tendency of microcrystalline cellulose tablets during a diametrical compression test

Furukawa¹,

Chen

Horiguchi

et al. 2015

International Journal of Pharmaceutics

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“…Then this situation requires an extensive investigation relying on trial-and-error approach to identify optimal (or working) recipe of process parameters even without finding out actual causes. 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.…”

Section: Quality: Mechanical Defectsmentioning

confidence: 99%

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

Cited by 27 publications

References 18 publications

A Practical Framework Toward Prediction of Breaking Force and Disintegration of Tablet Formulations Using Machine Learning Tools

A Practical Framework Toward Prediction of Breaking Force and Disintegration of Tablet Formulations Using Machine Learning Tools

Numerical evaluation of the capping tendency of microcrystalline cellulose tablets during a diametrical compression test

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

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