Roller compaction in pharmaceutical manufacturing: Comprehensive insights into processes, equipment, and formulation development
Main Article Content
Abstract
Roller compaction is a crucial operation in pharmaceutical manufacturing, offering a versatile approach to granulation and powder processing. This review provides a comprehensive overview of roller compaction in pharmaceutical production, including its principles, advantages, disadvantages, and recent trends. In addition, it explores formulation development for roller compaction, emphasizing critical quality attributes, suitable excipients, and the influence of material properties. Ultimately, this review is intended to serve as a valuable resource for pharmaceutical researchers, process engineers, and industry professionals aiming to enhance their understanding of roller compaction and its pivotal role in modern pharmaceutical manufacturing.
Downloads
Article Details

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
References
Al-Asady, R. B. H. (2016). Roller compaction: Mechanical properties of primary particles, pre-compacted body and ribbon [Doctoral dissertation, University of Sheffield]. White Rose eTheses Online. https://etheses.whiterose.ac.uk/15971/
Amini, H., & Akseli, I. (2021). A multi-variate mathematical model for simulating the granule size distribution in roller compaction-milling process. AAPS PharmSciTech, 22(3), Article 97. https://doi.org/10.1208/s12249-021-01955-6
Amini, H., Palahnuk, H., & Akseli, I. (2020). Population balance modeling (PBM) of ribbon milling in pharmaceutical roller compaction process. Powder Technology, 376, 438–457. https://doi.org/10.1016/j.powtec.2020.08.036
Arndt, O.-R., & Kleinebudde, P. (2018). Roll compaction and tableting of high loaded metformin formulations using efficient binders. AAPS PharmSciTech, 19(5), 2068–2076. https://doi.org/10.1208/s12249-018-1012-5
Augsburger, L. L., & Shangraw, R. F. (1966). Effect of glidants in tableting. Journal of Pharmaceutical Sciences, 55(4), 418–423. https://doi.org/10.1002/jps.2600550414
Bacher, C., Olsen, P. M., Bertelsen, P., Kristensen, J., & Sonnergaard, J. M. (2007). Improving the compaction properties of roller compacted calcium carbonate. International Journal of Pharmaceutics, 342(1), 115–123. https://doi.org/10.1016/j.ijpharm.2007.05.007
Bindhumadhavan, G., Seville, J. P. K., Adams, M. J., Greenwood, R. W., & Fitzpatrick, S. (2005). Roll compaction of a pharmaceutical excipient: Experimental validation of rolling theory for granular solids. Chemical Engineering Science, 60(14), 3891–3897. https://doi.org/10.1016/j.ces.2005.02.022
Builders, P. F., & Arhewoh, M. I. (2016). Pharmaceutical applications of native starch in conventional drug delivery. Starch - Stärke, 68(9–10), 864–873. https://doi.org/10.1002/star.201500337
Chaiya, P., & Phaechamud, T. (2020). Compatibility between magnesium stearate and pharmaceutical acidic active Compounds/Excipients with DSC. Key Engineering Materials, 856, 190–197. https://doi.org/10.4028/www.scientific.net/KEM.856.190
Clarke, J., Gamble, J. F., Jones, J. W., Tobyn, M., Dawson, N., Davies, C., Ingram, A., & Greenwood, R. (2020). Determining the impact of roller compaction processing conditions on granule and API properties. AAPS PharmSciTech, 21(6), Article 218. https://doi.org/10.1208/s12249-020-01773-2
Csordas, K., Wiedey, R., & Kleinebudde, P. (2018). Impact of roll compaction design, process parameters, and material deformation behaviour on ribbon relative density. Drug Development and Industrial Pharmacy, 44(8), 1295–1306. https://doi.org/10.1080/03639045.2018.1446444
Cunningham, J. C., Winstead, D., & Zavaliangos, A. (2010). Understanding variation in roller compaction through finite element-based process modeling. Computers & Chemical Engineering, 34(7), 1058–1071. https://doi.org/10.1016/j.compchemeng.2010.04.008
Darji, M. A., Lalge, R. M., Marathe, S. P., Mulay, T. D., Fatima, T., Alshammari, A., Lee, H. K., Repka, M. A., & Narasimha Murthy, S. (2018). Excipient stability in oral solid dosage forms: A review. AAPS PharmSciTech, 19(1), 12–26. https://doi.org/10.1208/s12249-017-0864-4
Dawoodbhai, S., & Rhodes, C. T. (1989). The effect of moisture on powder flow and on compaction and physical stability of tablets. Drug Development and Industrial Pharmacy, 15(10), 1577–1600. https://doi.org/10.3109/03639048909052504
Desai, P. M., Liew, C. V., & Heng, P. W. S. (2016). Review of disintegrants and the disintegration phenomena. Journal of Pharmaceutical Sciences, 105(9), 2545–2555. https://doi.org/10.1016/j.xphs.2015.12.019
Dürig, T. (2010). Binders in pharmaceutical granulation. In D. M. Parikh (Ed.), Handbook of pharmaceutical granulation technology (pp. 78–97). CRC Press. https://doi.org/10.3109/9781616310035
Emery, E., Oliver, J., Pugsley, T., Sharma, J., & Zhou, J. (2009). Flowability of moist pharmaceutical powders. Powder Technology, 189(3), 409–415. https://doi.org/10.1016/j.powtec.2008.06.017
Falzone, A. M., Peck, G. E., & McCabe, G. P. (1992). Effects of changes in roller compactor parameters on granulations produced by compaction. Drug Development and Industrial Pharmacy, 18(4), 469–489. https://doi.org/10.3109/03639049209043864
Farrenkopf, J. (2009). Relevant aspects of roller compaction covering the impact of excipients, milling devices, fines and feasibility prediction [Doctoral dissertation, University of Heidelberg]. heiDOK. http://www.ub.uni-heidelberg.de/archiv/10124
Ganesh, S., & Reklaitis, G. V. (2020). Basic principles of continuous manufacturing. In Z. K. Nagy, A. El Hagrasy, & J. Litster (Eds.), Continuous pharmaceutical processing (pp. 1–21). Springer. https://doi.org/10.1007/978-3-030-41524-2_1
Ghorab, M. K., Chatlapalli, R., Hasan, S., & Nagi, A. (2007). Application of thermal effusivity as a process analytical technology tool for monitoring and control of the roller compaction process. AAPS PharmSciTech, 8(1), Article 23. https://doi.org/10.1208/pt0801023
Gochioco, K. (2014). The effect of crystalline and amorphous lactose on mechanical properties of roller compaction ribbons and tablets [Master’s thesis, University of Kansas]. KU ScholarWorks. http://hdl.handle.net/1808/21642
Grodowska, K., & Parczewski, A. (2010). Organic solvents in the pharmaceutical industry. Acta Poloniae Pharmaceutica, 67(1), 3–12. https://pubmed.ncbi.nlm.nih.gov/20210074/
Grote, S., & Kleinebudde, P. (2019). A comparative study of the influence of alpha-lactose monohydrate particle morphology on granule and tablet properties after roll compaction/dry granulation. Pharmaceutical Development and Technology, 24(3), 314–322. https://doi.org/10.1080/10837450.2018.1476977
Grote, S., Osthues, H., Schaeffer, F., & Kleinebudde, P. (2019). The influence of isomalt particle morphology on tabletability after roll compaction/dry granulation. Powder Technology, 341, 59–65. https://doi.org/10.1016/j.powtec.2018.01.077
Gupta, A., Austin, J., Davis, S., Harris, M., & Reklaitis, G. (2015). A novel microwave sensor for real-time online monitoring of roll compacts of pharmaceutical powders online - a comparative case study with NIR. Journal of Pharmaceutical Sciences, 104(5), 1787–1794. https://doi.org/10.1002/jps.24409
Gupta, A., Peck, G. E., Miller, R. W., & Morris, K. R. (2004). Nondestructive measurements of the compact strength and the particle-size distribution after milling of roller compacted powders by near-infrared spectroscopy. Journal of Pharmaceutical Sciences, 93(4), 1047–1053. https://doi.org/10.1002/jps.20003
Gupta, A., Peck, G. E., Miller, R. W., & Morris, K. R. (2005). Effect of the variation in the ambient moisture on the compaction behavior of powder undergoing roller-compaction and on the characteristics of tablets produced from the post-milled granules. Journal of Pharmaceutical Sciences, 94(10), 2314–2326. https://doi.org/10.1002/jps.20414
Hancock, B. C., Carlson, G. T., Ladipo, D. D., Langdon, B. A., & Mullarney, M. P. (2002). Comparison of the mechanical properties of the crystalline and amorphous forms of a drug substance. International Journal of Pharmaceutics, 241(1), 73–85. https://doi.org/10.1016/S0378-5173(02)00133-3
Hare, C., Ghadiri, M., Guillard, N., Bosworth, T., & Egan, G. (2016). Analysis of milling of dry compacted ribbons by distinct element method. Chemical Engineering Science, 149, 204–214. https://doi.org/10.1016/j.ces.2016.04.041
He, X., Secreast, P. J., & Amidon, G. E. (2007). Mechanistic study of the effect of roller compaction and lubricant on tablet mechanical strength. Journal of Pharmaceutical Sciences, 96(5), 1342–1355. https://doi.org/10.1002/jps.20938
Herting, M. G., & Kleinebudde, P. (2007). Roll compaction/ dry granulation: Effect of raw material particle size on granule and tablet properties. International Journal of Pharmaceutics, 338(1), 110–118. https://doi.org/10.1016/j.ijpharm.2007.01.035
Herting, M. G., & Kleinebudde, P. (2008). Studies on the reduction of tensile strength of tablets after roll compaction/dry granulation. European Journal of Pharmaceutics and Biopharmaceutics, 70(1), 372–379. https://doi.org/10.1016/j.ejpb.2008.04.003
Hintz, R. J., & Johnson, K. C. (1989). The effect of particle size distribution on dissolution rate and oral absorption. International Journal of Pharmaceutics, 51(1), 9–17. https://doi.org/10.1016/0378-5173(89)90069-0
Hölzer, A. W., & Sjögren, J. (1979). Evaluation of sodium stearyl fumarate as a tablet lubricant. International Journal of Pharmaceutics, 2(3), 145–153. https://doi.org/10.1016/0378-5173(79)90015-2
Hong-Guang, W., & Ru-Hua, Z. (1995). Compaction behavior of paracetamol powders of different crystal shapes. Drug Development and Industrial Pharmacy, 21(7), 863–868. https://doi.org/10.3109/03639049509026651
Iyer, R. M., Hegde, S., DiNunzio, J., Singhal, D., & Malick, W. (2014). The impact of roller compaction and tablet compression on physicomechanical properties of pharmaceutical excipients. Pharmaceutical Development and Technology, 19(5), 583–592. https://doi.org/10.3109/10837450.2013.813541
Jang, E. H., Park, Y. S., & Choi, D. H. (2021). Investigation of the effects of materials and dry granulation process on the mirabegron tablet by integrated QbD approach with multivariate analysis. Powder Technology, 382, 23–39. https://doi.org/10.1016/j.powtec.2020.12.044
Janssen, P. H. M., Jaspers, M., Meier, R., Roelofs, T. P., & Dickhoff, B. H. J. (2022). The effect of excipient particle size on the reduction of compactibility after roller compaction. International Journal of Pharmaceutics: X, 4, Article 100117. https://doi.org/10.1016/j.ijpx.2022.100117
Johanson, J. R. (1965). A rolling theory for granular solids. Journal of Applied Mechanics, 32(4), 842–848. https://doi.org/10.1115/1.3627325
Karkala, V. P., Jinadatharaya, H., Gowda, D. V., & Sivadasu, P. (2018). Development and evaluation of nevirapine extended release tablets using QbD approach. Indian Journal of Pharmaceutical Education and Research, 52(4), 220–228. https://doi.org/10.5530/ijper.52.4s.101
Katashinskii, V. P. (1966). Analytical determination of specific pressure during the rolling of metal powders. Soviet Powder Metallurgy and Metal Ceramics, 5(10), 765–772. https://doi.org/10.1007/BF00776244
Kazemi, P., Khalid, M. H., Szlek, J., Mirtič, A., Reynolds, G. K., Jachowicz, R., & Mendyk, A. (2016). Computational intelligence modeling of granule size distribution for oscillating milling. Powder Technology, 301, 1252–1258. https://doi.org/10.1016/j.powtec.2016.07.046
Kerche, E. F., Kairytė, A., Członka, S., da Silva, V. D., Salles, N. A., Schrekker, H. S., & Amico, S. C. (2023). Imidazolium ionic liquids as compatibilizer agents for microcrystalline cellulose/epoxy composites. Polymers, 15(2), Article 333. https://doi.org/10.3390/polym15020333
Khan, F., Pilpel, N., & Ingham, S. (1988). The effect of moisture on the density, compaction and tensile strength of microcrystalline cellulose. Powder Technology, 54(3), 161–164. https://doi.org/10.1016/0032-5910(88)80074-3
Khorasani, M., Amigo, J. M., Sonnergaard, J., Olsen, P., Bertelsen, P., & Rantanen, J. (2015). Visualization and prediction of porosity in roller compacted ribbons with near-infrared chemical imaging (NIR-CI). Journal of Pharmaceutical and Biomedical Analysis, 109, 11–17. https://doi.org/10.1016/j.jpba.2015.02.008
Kleinebudde, P. (2004). Roll compaction/dry granulation: Pharmaceutical applications. European Journal of Pharmaceutics and Biopharmaceutics, 58(2), 317–326. https://doi.org/10.1016/j.ejpb.2004.04.014
Kristensen, H. G., & Schaefer, T. (1987). Granulation: A review on pharmaceutical wet-granulation. Drug Development and Industrial Pharmacy, 13(4–5), 803–872. https://doi.org/10.3109/03639048709105217
LaMarche, K., Buckley, D., Hartley, R., Qian, F., & Badawy, S. (2014). Assessing materials’ tablet compaction properties using the Drucker–Prager cap model. Powder Technology, 267, 208–220. https://doi.org/10.1016/j.powtec.2014.06.050
Leane, M., Pitt, K., & Reynolds, G. (2015). A proposal for a drug product manufacturing classification System (MCS) for oral solid dosage forms. Pharmaceutical Development and Technology, 20(1), 12–21. https://doi.org/10.3109/10837450.2014.954728
Lee, B.-J. (2010). Pharmaceutical preformulation: Physicochemical properties of excipients and powders and tablet characterization. In S. C. Gad (Ed.), Pharmaceutical sciences encyclopedia (pp. 881–932). John Wiley & Sons. https://doi.org/10.1002/9780470571224.pse362
Lerk, C. F. (1993). Consolidation and compaction of lactose. Drug Development and Industrial Pharmacy, 19(17–18), 2359–2398. https://doi.org/10.3109/03639049309047195
Loreti, S., Wu, C.-Y., Reynolds, G., Mirtič, A., & Seville, J. (2017). DEM–PBM modeling of impact dominated ribbon milling. AIChE Journal, 63(9), 3692–3705. https://doi.org/10.1002/aic.15721
Lück, M., De Saeger, M., & Kleinebudde, P. (2022). Influence of roll speed during roll compaction and its effect on the prediction of ribbon solid fraction. Pharmaceutics, 14(11), Article 2399. https://doi.org/10.3390/pharmaceutics14112399
Mazor, A., Orefice, L., Michrafy, A., de Ryck, A., & Khinast, J. G. (2018). A combined DEM & FEM approach for modelling roll compaction process. Powder Technology, 337, 3–16. https://doi.org/10.1016/j.powtec.2017.04.053
McAuliffe, M. A. P., O’Mahony, G. E., Blackshields, C. A., Collins, J. A., Egan, D. P., Kiernan, L., O’Neill, E., Lenihan, S., Walker, G. M., & Crean, A. M. (2015). The use of PAT and off-line methods for monitoring of roller compacted ribbon and granule properties with a view to continuous processing. Organic Process Research and Development, 19(1), 158–166. https://doi.org/10.1021/op5000013
McKenna, A., & McCafferty, D. (1982). Effect of particle size on the compaction mechanism and tensile strength of tablets. Journal of Pharmacy and Pharmacology, 34(6), 347–351. https://doi.org/10.1111/j.2042-7158.1982.tb04727.x
Merkus, H. G. (2009). Particle size, size distributions and shape. In H. G. Merkus (Ed.), Particle size measurements: Fundamentals, practice, quality (pp. 13–42). Springer. https://doi.org/10.1007/978-1-4020-9016-5_2
Miguélez-Morán, A. M., Wu, C. Y., & Seville, J. P. K. (2008). The effect of lubrication on density distributions of roller compacted ribbons. International Journal of Pharmaceutics, 362(1), 52–59. https://doi.org/10.1016/j.ijpharm.2008.06.009
Miller, R. W. (2005). Roller compaction technology. In D. M. Parikh (Ed.), Handbook of pharmaceutical granulation technology (pp. 159–190). CRC Press. https://doi.org/10.1201/9780849354953-9
Miller, T. A., & York, P. (1988). Pharmaceutical tablet lubrication. International Journal of Pharmaceutics, 41(1–2), 1–19. https://doi.org/10.1016/0378-5173(88)90130-5
Mishra, V., Thakur, S., Patil, A., & Shukla, A. (2018). Quality by design (QbD) approaches in current pharmaceutical set-up. Expert Opinion on Drug Delivery, 15(8), 737–758. https://doi.org/10.1080/17425247.2018.1504768
Mohan, S. (2012). Compression physics of pharmaceutical powders: A review. International Journal of Pharmaceutical Sciences and Research, 3(6), 1580–1592. https://doi.org/10.13040/IJPSR.0975-8232.3(6).1580-92
Muliadi, A. R., Banda, A., & Mao, C. (2020). Recent progress in roll compaction process development for pharmaceutical solid dosage form manufacture. In Z. K. Nagy, A. El Hagrasy, & J. Litster (Eds.), Continuous pharmaceutical processing (pp. 227–267). Springer. https://doi.org/10.1007/978-3-030-41524-2_7
Muliadi, A. R., Litster, J. D., & Wassgren, C. R. (2013). Validation of 3-D finite element analysis for predicting the density distribution of roll compacted pharmaceutical powder. Powder Technology, 237, 386–399. https://doi.org/10.1016/j.powtec.2012.12.023
Nordström, J., & Alderborn, G. (2015). The granule porosity controls the loss of compactibility for both dry- and wet-processed cellulose granules but at different rate. Journal of Pharmaceutical Sciences, 104(6), 2029–2039. https://doi.org/10.1002/jps.24439
Ohrem, H. L., Schornick, E., Kalivoda, A., & Ognibene, R. (2014). Why is mannitol becoming more and more popular as a pharmaceutical excipient in solid dosage forms? Pharmaceutical Development and Technology, 19(3), 257–262. https://doi.org/10.3109/10837450.2013.775154
Omar, C. S., Dhenge, R. M., Osborne, J. D., Althaus, T. O., Palzer, S., Hounslow, M. J., & Salman, A. D. (2015). Roller compaction: Effect of morphology and amorphous content of lactose powder on product quality. International Journal of Pharmaceutics, 496(1), 63–74. https://doi.org/10.1016/j.ijpharm.2015.06.032
Omar, C. S., Hounslow, M. J., & Salman, A. D. (2018). Implementation of an online thermal imaging to study the effect of process parameters of roller compactor. Drug Delivery and Translational Research, 8(6), 1604–1614. https://doi.org/10.1007/s13346-018-0493-9
Osborne, J. D., Althaus, T., Forny, L., Niederreiter, G., Palzer, S., Hounslow, M. J., & Salman, A. D. (2013). Investigating the influence of moisture content and pressure on the bonding mechanisms during roller compaction of an amorphous material. Chemical Engineering Science, 86, 61–69. https://doi.org/10.1016/j.ces.2012.05.012
Otsuka, M., Yamane, I., & Matsuda, Y. (2004). Effects of lubricant mixing on compression properties of various kinds of direct compression excipients and physical properties of the tablets. Advanced Powder Technology, 15(4), 477–493. https://doi.org/10.1163/1568552041270563
Pandey, P., Bharadwaj, R., & Chen, X. (2017). Modeling of drug product manufacturing processes in the pharmaceutical industry. In P. Pandey & R. Bharadwaj (Eds.), Predictive modeling of pharmaceutical unit operations (pp. 1–13). Woodhead Publishing. https://doi.org/10.1016/B978-0-08-100154-7.00001-6
Parikh, D. M. (2010). Introduction. In D. M. Parikh (Ed.), Handbook of pharmaceutical granulation technology (pp. 1–5). CRC Press. https://doi.org/10.3109/9781616310035-4
Perez-Gandarillas, L., Mazor, A., Souriou, D., Lecoq, O., & Michrafy, A. (2015). Compaction behaviour of dry granulated binary mixtures. Powder Technology, 285, 62–67. https://doi.org/10.1016/j.powtec.2015.05.003
Perez-Gandarillas, L., Perez-Gago, A., Mazor, A., Kleinebudde, P., Lecoq, O., & Michrafy, A. (2016). Effect of roll-compaction and milling conditions on granules and tablet properties. European Journal of Pharmaceutics and Biopharmaceutics, 106, 38–49. https://doi.org/10.1016/j.ejpb.2016.05.020
Propst, C. W. (2002). Tablet processing. In Problem solver and reference manual (pp. 1–23). FMC Biopolymers. https://www.scribd.com/document/224225256/02-TabletProcessing
Reier, G. E., & Shangraw, R. F. (1966). Microcrystalline cellulose in tableting. Journal of Pharmaceutical Sciences, 55(5), 510–514. https://doi.org/10.1002/jps.2600550513
Rekhi, G. S., & Sidwell, R. (2010). Sizing of granulation. In D. M. Parikh (Ed.), Handbook of pharmaceutical granulation technology (pp. 519–540). CRC Press. https://doi.org/10.3109/9781616310035-24
Roberts, R. J., & Rowe, R. C. (1987). Brittle/ductile behaviour in pharmaceutical materials used in tabletting. International Journal of Pharmaceutics, 36(2), 205–209. https://doi.org/10.1016/0378-5173(87)90157-8
Rogers, A. J., Hashemi, A., & Ierapetritou, M. G. (2013). Modeling of particulate processes for the continuous manufacture of solid-based pharmaceutical dosage forms. Processes, 1(2), 67–127. https://doi.org/10.3390/pr1020067
Rowe, J. M., Charlton, S. T., & McCann, R. J. (2017). Chapter 32 - development, scale-up, and optimization of process parameters: Roller compaction theory and practice. In Y. Qiu, Y. Chen, G. G. Z. Zhang, L. Yu, & R. V. Mantri (Eds.), Developing solid oral dosage forms (pp. 869–915). Academic Press. https://doi.org/10.1016/B978-0-12-802447-8.00032-7
Sajjia, M., Shirazian, S., Kelly, C. B., Albadarin, A. B., & Walker, G. (2017). ANN analysis of a roller compaction process in the pharmaceutical industry. Chemical Engineering and Technology, 40(3), 487–492. https://doi.org/10.1002/ceat.201600229
Sakwanichol, J., Puttipipatkhachorn, S., Ingenerf, G., & Kleinebudde, P. (2012). Roll compaction/dry granulation: Comparison between roll mill and oscillating granulator in dry granulation. Pharmaceutical Development and Technology, 17(1), 30–39. https://doi.org/10.3109/10837450.2010.508078
Samanta, A. K., Ng, K. Y., & Heng, P. W. S. (2012). Cone milling of compacted flakes: Process parameter selection by adopting the minimal fines approach. International Journal of Pharmaceutics, 422(1), 17–23. https://doi.org/10.1016/j.ijpharm.2011.10.015
Sangshetti, J. N., Deshpande, M., Zaheer, Z., Shinde, D. B., & Arote, R. (2017). Quality by design approach: Regulatory need. Arabian Journal of Chemistry, 10, S3412–S3425. https://doi.org/10.1016/j.arabjc.2014.01.025
Shah, M. A., & Wilson, R. G. (1968). Some effects of humidity and heat on the tableting properties of microcrystalline cellulose formulations I. Journal of Pharmaceutical Sciences, 57(1), 181–182. https://doi.org/10.1002/jps.2600570141
Shaikh, R., O’Brien, D. P., Croker, D. M., & Walker, G. M. (2018). Chapter 2 - The development of a pharmaceutical oral solid dosage forms. In R. Singh & Z. Yuan (Eds.), Computer aided chemical engineering (Vol. 41, pp. 27–65). Elsevier. https://doi.org/10.1016/B978-0-444-63963-9.00002-6
Sheskey, P. J., Cook, W. G., & Cable, C. G. (2017). Handbook of pharmaceutical excipients (8th ed.). Pharmaceutical Press.
Singh, R., Ierapetritou, M., & Ramachandran, R. (2012). An engineering study on the enhanced control and operation of continuous manufacturing of pharmaceutical tablets via roller compaction. International Journal of Pharmaceutics, 438(1), 307–326. https://doi.org/10.1016/j.ijpharm.2012.09.009
Soh, J. L. P., Wang, F., Boersen, N., Pinal, R., Peck, G. E., Carvajal, M. T., Cheney, J., Valthorsson, H., & Pazdan, J. (2008). Utility of multivariate analysis in modeling the effects of raw material properties and operating parameters on granule and ribbon properties prepared in roller compaction. Drug Development and Industrial Pharmacy, 34(10), 1022–1035. https://doi.org/10.1080/03639040801925990
Souihi, N., Josefson, M., Tajarobi, P., Gururajan, B., & Trygg, J. (2013). Design space estimation of the roller compaction process. Industrial & Engineering Chemistry Research, 52(35), 12408–12419. https://doi.org/10.1021/ie303580y
Souihi, N., Reynolds, G., Tajarobi, P., Wikström, H., Haeffler, G., Josefson, M., & Trygg, J. (2015). Roll compaction process modeling: Transfer between equipment and impact of process parameters. International Journal of Pharmaceutics, 484(1), 192–206. https://doi.org/10.1016/j.ijpharm.2015.02.042
Sousa, R., Valente, P. C., Nakach, M., Bardet, L., Wacquet, M., Midoux, N., & Authelin, J.-R. (2020). Roller compaction scale-up made simple: An approximate analytical solution to Johanson’s rolling theory. Journal of Pharmaceutical Sciences, 109(8), 2536–2543. https://doi.org/10.1016/j.xphs.2020.05.004
Sun, C. C., & Kleinebudde, P. (2016). Mini review: Mechanisms to the loss of tabletability by dry granulation. European Journal of Pharmaceutics and Biopharmaceutics, 106, 9–14. https://doi.org/10.1016/j.ejpb.2016.04.003
Sun, W.-J., Rantanen, J., & Sun, C. C. (2018). Ribbon density and milling parameters that determine fines fraction in a dry granulation. Powder Technology, 338, 162–167. https://doi.org/10.1016/j.powtec.2018.07.009
Teng, Y., Qiu, Z., & Wen, H. (2009). Systematical approach of formulation and process development using roller compaction. European Journal of Pharmaceutics and Biopharmaceutics, 73(2), 219–229. https://doi.org/10.1016/j.ejpb.2009.04.008
Tomar, M., Shah, J., Sinha, A. R., & Singh, A. K. (2018). Silicified microcrystalline cellulose, modern co-processed excipient for low dose solid dosage forms. European Journal of Biomedical and Pharmaceutical Sciences, 5(1), 722–731. https://www.ejbps.com/ejbps/abstract_id/3701
Toson, P., Lopes, D. G., Paus, R., Kumar, A., Geens, J., Stibale, S., Quodbach, J., Kleinebudde, P., Hsiao, W.-K., & Khinast, J. (2019). Model-based approach to the design of pharmaceutical roller-compaction processes. International Journal of Pharmaceutics: X, 1, Article 100005. https://doi.org/10.1016/j.ijpx.2019.100005
Wade, J. B. (2019). Chapter 1 - Physicochemical principles governing agglomeration and growth kinetics. In A. S. Narang & S. I. F. Badawy (Eds.), Handbook of pharmaceutical wet granulation (pp. 3–35). Academic Press. https://doi.org/10.1016/B978-0-12-810460-6.00002-6
Weyenberg, W., Vermeire, A., Vandervoort, J., Remon, J. P., & Ludwig, A. (2005). Effects of roller compaction settings on the preparation of bioadhesive granules and ocular minitablets. European Journal of Pharmaceutics and Biopharmaceutics, 59(3), 527–536. https://doi.org/10.1016/j.ejpb.2004.09.012
Wiedey, R., & Kleinebudde, P. (2017). The density distribution in ribbons from roll compaction. Chemie Ingenieur Technik, 89(8), 1017–1024. https://doi.org/10.1002/cite.201600143
Wilms, A., Teske, A., Meier, R., Wiedey, R., & Kleinebudde, P. (2022). Implementing feedback granule size control in a continuous dry granulation line using controlled impeller speed of the granulation unit, compaction force and gap width. Journal of Pharmaceutical Innovation, 17(2), 449–459. https://doi.org/10.1007/s12247-020-09524-3
Wu, C. Y., Hung, W. L., Miguélez-Morán, A. M., Gururajan, B., & Seville, J. P. K. (2010). Roller compaction of moist pharmaceutical powders. International Journal of Pharmaceutics, 391(1), 90–97. https://doi.org/10.1016/j.ijpharm.2010.02.022
Yoshinari, T., Forbes, R. T., York, P., & Kawashima, Y. (2003). The improved compaction properties of mannitol after a moisture-induced polymorphic transition. International Journal of Pharmaceutics, 258(1), 121–131. https://doi.org/10.1016/S0378-5173(03)00157-1
Yu, S., Adams, M., Gururajan, B., Reynolds, G., Roberts, R., & Wu, C.-Y. (2013). The effects of lubrication on roll compaction, ribbon milling and tabletting. Chemical Engineering Science, 86, 9–18. https://doi.org/10.1016/j.ces.2012.02.026
Zarmpi, P., Flanagan, T., Meehan, E., Mann, J., & Fotaki, N. (2017). Biopharmaceutical aspects and implications of excipient variability in drug product performance. European Journal of Pharmaceutics and Biopharmaceutics, 111, 1–15. https://doi.org/10.1016/j.ejpb.2016.11.004