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Methodology to estimate the break force of pharmaceutical tablets with curved faces under diametrical compression.
Int J Pharm. 2019 Jan 10; 554:399-419.IJ

Abstract

This paper develops a methodology to estimate the break force of curved faced tablets under diametrical compression. Common excipients used in pharmaceutical tablet formulations, including microcrystalline cellulose, calcium phosphate and mannitol as well as their mixtures were characterised. Compacts of different densities were manufactured and their compressive and tensile strength was measured. The break force of curved face tablets having a comprehensive range of face curvatures and thickness was measured using the diametrical compression method ("hardness" test). Equation σd=FπD2atD+bWD-1 introduced by Shang et al. (2013) was used to relate the break force (F) to tablet geometry (D, t, W) and material tensile strength (σd). Here, we propose a method to estimate the parameters a and b using data for flat faced tablets. The method was validated for four mixtures. The errors were analysed and compared with the USP29 method σd=10FπD2(2.84(t/D)-0.126t/W+3.15(W/D)+0.01)-1. The proposed method has better accuracy, however, requires additional characterisation of the compressive strength of the material.

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Publisher Full Text (DOI)

Authors+Show Affiliations

Al-Sabbagh M
Department of Engineering, University of Leicester, University Road, Leicester LE1 7RH, UK; Department of Mechanical Engineering, Al-Mustansiriyah University, Baghdad, Iraq.
Polak P
Department of Engineering, University of Leicester, University Road, Leicester LE1 7RH, UK.
Roberts RJ
Pharmaceutical Technology & Development, AstraZeneca, Macclesfield SK10 2NA, UK.
Reynolds GK
Pharmaceutical Technology & Development, AstraZeneca, Macclesfield SK10 2NA, UK.
Sinka IC
Department of Engineering, University of Leicester, University Road, Leicester LE1 7RH, UK. Electronic address: ics4@le.ac.uk.

MeSH

Chemistry, PharmaceuticalCompressive StrengthDrug CompoundingExcipientsHardness TestsPharmaceutical PreparationsPressureReproducibility of ResultsTabletsTechnology, PharmaceuticalTensile Strength

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

30308275

Citation

Al-Sabbagh, M, et al. "Methodology to Estimate the Break Force of Pharmaceutical Tablets With Curved Faces Under Diametrical Compression." International Journal of Pharmaceutics, vol. 554, 2019, pp. 399-419.
Al-Sabbagh M, Polak P, Roberts RJ, et al. Methodology to estimate the break force of pharmaceutical tablets with curved faces under diametrical compression. Int J Pharm. 2019;554:399-419.
Al-Sabbagh, M., Polak, P., Roberts, R. J., Reynolds, G. K., & Sinka, I. C. (2019). Methodology to estimate the break force of pharmaceutical tablets with curved faces under diametrical compression. International Journal of Pharmaceutics, 554, 399-419. https://doi.org/10.1016/j.ijpharm.2018.10.014
Al-Sabbagh M, et al. Methodology to Estimate the Break Force of Pharmaceutical Tablets With Curved Faces Under Diametrical Compression. Int J Pharm. 2019 Jan 10;554:399-419. PubMed PMID: 30308275.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Methodology to estimate the break force of pharmaceutical tablets with curved faces under diametrical compression. AU - Al-Sabbagh,M, AU - Polak,P, AU - Roberts,R J, AU - Reynolds,G K, AU - Sinka,I C, Y1 - 2018/10/08/ PY - 2018/06/13/received PY - 2018/09/16/revised PY - 2018/10/06/accepted PY - 2018/10/12/pubmed PY - 2019/4/4/medline PY - 2018/10/12/entrez KW - Break force KW - Diametrical compression test KW - Powder KW - Tablet KW - Tensile strength SP - 399 EP - 419 JF - International journal of pharmaceutics JO - Int J Pharm VL - 554 N2 - This paper develops a methodology to estimate the break force of curved faced tablets under diametrical compression. Common excipients used in pharmaceutical tablet formulations, including microcrystalline cellulose, calcium phosphate and mannitol as well as their mixtures were characterised. Compacts of different densities were manufactured and their compressive and tensile strength was measured. The break force of curved face tablets having a comprehensive range of face curvatures and thickness was measured using the diametrical compression method ("hardness" test). Equation σd=FπD2atD+bWD-1 introduced by Shang et al. (2013) was used to relate the break force (F) to tablet geometry (D, t, W) and material tensile strength (σd). Here, we propose a method to estimate the parameters a and b using data for flat faced tablets. The method was validated for four mixtures. The errors were analysed and compared with the USP29 method σd=10FπD2(2.84(t/D)-0.126t/W+3.15(W/D)+0.01)-1. The proposed method has better accuracy, however, requires additional characterisation of the compressive strength of the material. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/30308275/Methodology_to_estimate_the_break_force_of_pharmaceutical_tablets_with_curved_faces_under_diametrical_compression_ DB - PRIME DP - Unbound Medicine ER -