Effect of excipient particle size distribution variability on compact tensile strength; and its in-line prediction by force-displacement and force-time profiling

European Journal of Pharmaceutical Sciences - Tập 159 - Trang 105703 - 2021
Wee Beng Lee1, Effendi Widjaja2, Paul Wan Sia Heng1, Lai Wah Chan1
1GEA-NUS Pharmaceutical Processing Research Laboratory, Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore 117543, Singapore
2MSD International GmbH, 50 Tuas West Drive, Singapore 638408, Singapore

Tài liệu tham khảo

Al-Zoubi, 2020, Mechanical properties of starch esters at particle and compact level - Comparisons and exploration of the applicability of Hiestand's equation to predict tablet strength, Eur. J. Pharm. Sci., 147, 10.1016/j.ejps.2020.105292 Bolhuis, 2011, Compaction properties of directly compressible materials, 143 2016, V Càrdenas, 2014, Strategies for selecting the calibration set in pharmaceutical near infrared spectroscopy analysis. A comparative study, J. Pharm. Innov., 9, 272, 10.1007/s12247-014-9192-3 Chen, 2001, Prediction of drug content and hardness of intact tablets using artificial neural network and near-infrared spectroscopy, Drug Dev. Ind. Pharm., 27, 623, 10.1081/DDC-100107318 Cogdill, 2007, Synthetic calibration for efficient method development: analysis of tablet API concentration by near-infrared spectroscopy, J. Pharm. Innov., 2, 93, 10.1007/s12247-007-9012-0 Danish, 1971, Flow rates of solid particulate pharmaceuticals, J. Pharm. Sci., 60, 548, 10.1002/jps.2600600407 Donoso, 2008, Prediction of tablet hardness and porosity using near-infrared diffuse reflectance spectroscopy as a nondestructive method, Pharm. Dev. Technol., 8, 357, 10.1081/PDT-120024689 Fell, 1968, The tensile strength of lactose tablets, J. Pharm. Pharmacol., 20, 657, 10.1111/j.2042-7158.1968.tb09832.x Gold, 1968, Powder flow studies III. Factors affecting the flow of lactose granules, J. Pharm. Sci., 57, 667, 10.1002/jps.2600570429 Halenius, 2014, Fast tablet tensile strength prediction based on non-invasive analytics, AAPS PharmSciTech, 15, 781, 10.1208/s12249-014-0104-0 2009, 1 IPQ, 2016. International Pharmaceutical Quality, PQRI survey results illustrate broad and costly impact of excipient variability. pp. 1–2. IQ, 2013. International Consortium for Innovation and Quality in Pharmaceutical Development, A survey to understand the current practices between pharmaceutical companies and excipient suppliers in evaluating the impact of excipient on drug product performance contributors. pp. 1–32. Jones, 1965, Some physical properties of lactose and magnesia, J. Pharm. Pharmacol., 7, 440 Kirsch, 1999, Nondestructive tablet hardness testing by near-infrared spectroscopy: a new and robust spectral best-fit algorithm, J. Pharm. Biomed. Anal., 3, 351, 10.1016/S0731-7085(98)00132-0 Kushner, 2010, Examining the impact of excipient material property variation on drug product quality attributes: a quality-by-design study for a roller compacted, immediate release tablet, J. Pharm. Sci., 100, 2222, 10.1002/jps.22455 Lee, 2019, Investigating the effect and mechanism of particle size distribution variability on mixing using avalanche testing and multivariate modelling, Int. J. Pharm., 563, 9, 10.1016/j.ijpharm.2019.03.045 Lee, 2020, The effect of rotation speed and particle size distribution variability on mixability: an avalanche rheological and multivariate image analytical approach, Int. J. Pharm., 579, 10.1016/j.ijpharm.2020.119128 Lum, 2011, Viscoelastic models, 2011, 9 Maschinot, 2017, A few tips on compressing the perfect tablet, Tablets Capsul., 15, 64 May, 2013, Hardness and density distributions of pharmaceutical tablets measured by terahertz pulsed imaging, J. Pharm. Sci., 102, 2179, 10.1002/jps.23560 McCormick, 2006, Evolutions in direct compression, Pharm. Technol., 29, 52 McKenna, 1982, Effect of particle size on the compaction mechanism and tensile strength of tablets, J. Pharm. Pharmacol., 34, 347, 10.1111/j.2042-7158.1982.tb04727.x Meggle, 2014a. Tablettose® Technical Brochure. pp. 1–8. Meggle, 2014b. Milled and Sieved Lactose. pp. 1–8. Oliver, 1992, An improved technique for determining hardness and elastic modulus using load and displacement sensing indentation experiments, J. Mater. Res. Technol., 7, 1564, 10.1557/JMR.1992.1564 Peeters, 2016, Assessment and prediction of tablet properties using transmission and backscattering Raman spectroscopy and transmission NIR spectroscopy, Asian J. Pharm. Sci., 11, 547, 10.1016/j.ajps.2016.04.004 Persson, 2018, A hybrid approach to predict the relationship between tablet tensile strength and compaction pressure using analytical powder compression, Eur. J. Pharm. Biopharm., 125, 28, 10.1016/j.ejpb.2017.12.011 Razavi, 2019, Toward predicting tensile strength of pharmaceutical tablets by ultrasound measurement in continuous manufacturing, Int. J. Pharm., 507, 83, 10.1016/j.ijpharm.2016.04.064 Razavi, 2018, Quantification of lubrication and particle size distribution effects on tensile strength and stiffness of tablets, Powder Technol., 336, 360, 10.1016/j.powtec.2018.06.001 Riepma, 1991, Consolidation and compaction of powder mixture: II. Binary mixtures of different particle size fractions of a-lactose monohydrate, Int. J. Pharm., 76, 9, 10.1016/0378-5173(91)90338-O Rizzuto, 1984, Modification of the sucrose crystal structure to enhance pharmaceutical properties of excipient and drug substances, Pharm. Technol., 8, 32 Roberts, 1985, The effect of punch velocity on the compaction of a variety of materials, J. Pharm. Pharmacol., 37, 377, 10.1111/j.2042-7158.1985.tb03019.x Shi, 2017, Effect of particle size and cohesion on powder yielding and flow, KONA Powder Part. J., 35, 226, 10.14356/kona.2018014 Short, 2009, J. A near-infrared spectroscopic investigation of relative density and crushing strength in four-component compacts, Pharm. Sci., 98, 1095, 10.1002/jps.21473 Takahashi, 2020, Application of novel compaction indicator for the optimization of compaction conditions based on a compaction simulation study, Int. J. Pharm., 587, 10.1016/j.ijpharm.2020.119574 Teh, 2020, Impact of die wall material on the mechanical properties of paracetamol tablets, Int. J. Pharm., 25 2012, 868 Tukey, 1949, Comparing individual means in the analysis of variance, Biom., 5, 99, 10.2307/3001913 2004, 1 2004, 1 Virtanen, 2008, Determination of the crushing strength of intact tablets using Raman spectroscopy, Int. J. Pharm., 360, 40, 10.1016/j.ijpharm.2008.04.022 Vromans, 1986, Studies on tabletine; properties of lactose; the effect of initial particle size on binding properties and dehydration characteristics of α-lactose monohydrate, Drug Dev. Ind. Pharm., 12, 1715, 10.3109/03639048609042605 Alderborn G., Frenning G., 2008 Mechanical strength of tablets, in: Augsburger L.L., Hoag S.W. (Eds.), Pharmaceutical Dosage forms. Tablets: Volume 3. Tablets Manufacture and Process Control. New York: Informa Healthcare. 2008 pp. 207–236.