Development of Direct Compression Continuous Manufacturing System for Low-Dose Drug Products
A continuous direct compression process for a low-dose drug product was proposed. Acetaminophen was used for the model drug, and the mixing and tableting experiments with the low content were conducted using direct compression continuous manufacturing system. A low-dose continuous mixing was conduct...
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| Published in | Funtai Kogakkaishi Vol. 57; no. 5; pp. 233 - 240 |
|---|---|
| Main Authors | , , , , |
| Format | Journal Article |
| Language | Japanese |
| Published |
Kyoto
The Society of Powder Technology, Japan
10.05.2020
Japan Science and Technology Agency |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0386-6157 1883-7239 |
| DOI | 10.4164/sptj.57.233 |
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| Abstract | A continuous direct compression process for a low-dose drug product was proposed. Acetaminophen was used for the model drug, and the mixing and tableting experiments with the low content were conducted using direct compression continuous manufacturing system. A low-dose continuous mixing was conducted in two steps. It was found that it is important to select the similar particle size for both drug and excipient in the first step mixing, and the result of the tableting experiment, the tablet contained 1% API indicated the good content uniformity. The experimental result of the second step, it was difficult to obtain the tablet contained 0.01% API with the good content uniformity. It was suggested that it is important to use jet-milled drug instead of using non-pulverized drug in the second step. |
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| AbstractList | A continuous direct compression process for a low-dose drug product was proposed. Acetaminophen was used for the model drug, and the mixing and tableting experiments with the low content were conducted using direct compression continuous manufacturing system. A low-dose continuous mixing was conducted in two steps. It was found that it is important to select the similar particle size for both drug and excipient in the first step mixing, and the result of the tableting experiment, the tablet contained 1% API indicated the good content uniformity. The experimental result of the second step, it was difficult to obtain the tablet contained 0.01% API with the good content uniformity. It was suggested that it is important to use jet-milled drug instead of using non-pulverized drug in the second step. |
| Author | Horibe, Masashi Watano, Satoru Takusagawa, Shota Fushimi, Shinsuke Sonoda, Ryoichi |
| Author_xml | – sequence: 1 fullname: Fushimi, Shinsuke organization: Technical Center, KIKUSUI SEISAKUSHO Ltd – sequence: 1 fullname: Horibe, Masashi organization: Formulation Department, CMC Center, Kaken Pharmaceutical Co. Ltd – sequence: 1 fullname: Sonoda, Ryoichi organization: Formulation Department, CMC Center, Kaken Pharmaceutical Co. Ltd – sequence: 1 fullname: Takusagawa, Shota organization: Formulation Department, CMC Center, Kaken Pharmaceutical Co. Ltd – sequence: 1 fullname: Watano, Satoru organization: Graduate School of Engineering, Osaka Prefecture University |
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| Cites_doi | 10.4164/sptj.57.12 10.1002/jps.24582 10.1016/j.ijpharm.2008.01.012 10.1016/S0378-5173(97)00134-8 10.1016/j.ijpharm.2017.01.010 10.1016/j.ijpharm.2017.04.055 10.1016/j.ijpharm.2017.07.003 10.1016/j.powtec.2012.03.009 10.1248/cpb.c17-01026 10.1002/jps.24343 10.1021/acs.iecr.7b05230 10.1021/ie2006752 |
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| References | [1] H. Nakamura, H. Fujii, S. Watano, Scale-up of high shear mixer-granulator based on discrete element analysis, Powder Technol. 236 (2013) 149–156. [13] B. V. Snick, J. Holman, V. Vanhoorne, A. Kumar, T. D. Beer, J. P. Remon, C. Vervaet, Development of a continuous direct compression platform for low-dose drug products, Int. J. Pharm. 529 (2017) 329–346. [9] S. D. Schaber, D. I. Gerogiorgis, R. Ramachandran, J. M. B. Evans, P. I. Barton, B. L. Trout, Economic analysis of integrated continuous and batch pharmaceutical manufacturing: A case study, Ind. Eng. Chem. Res. 50 (2011) 10083–10092. [3] M. Ito, S. Aoki, J. Uchiyama, K. Yamato, Development of a new punch head shape to replicate scale-up issues on a laboratory tablet press III: Replicating sticking phenomenon using the SAS punch and evaluation by checking the tablet surface using 3-D laser scanning microscope, J. Pharm. Sci. 107 (2018) 2144–2151. [15] Y. Kato, K. Matsumoto, M. Ohkuma, H. Sunada, Rapidly disintegrating tablets prepared by a surface-modifying method, J. Pharm. Sci. Technol. Jpn. 62 (2002) 87–94. [8] K. Matsunami, T. Miyano, H. Arai, H. Nakagawa, M. Hirao, H. Sugiyama, Decision support method for the choice between batch and continuous technologies in solid drug product manufacturing, Ind. Eng. Chem. Res. 57 (2018) 9798–9809. [5] S. J. Srai, C. Badman, M. Krumme, M. Futran, C. Johnston, Future supply chains enabled by continuous processing — opportunities challenges May 20–21 2014 continuous manufacturing symposium, J. Pharm. Sci. 104 (2015) 840–849. [14] M. Horibe, R. Sonoda, S. Watano, Scale-up of low drug content formulation, J. Soc. Powder. Technol. Japan 57 (2020) 12–18. [11] H. Liu, S. C. Galbraith, B. Ricart, C. Stanton, B. S. Goettler, L. Verdi, T. O’Connor, S. Lee, S. Yoon, Optimization of critical quality attributes in continuous twin-screw wet granulation via design space validated with pilot scale experimental data, Int. J. Pharm. 525 (2017) 249–263. [16] Y. Zhang, K. C. Johnson, Effect of drug particle size on content uniformity of low-dose solid dosage forms, Int. J. Pharm. 154 (1997) 179–183. [10] B. V. Melkebeke, C. Vervaet, J. P. Remon, Validation of a continuous granulation process using a twin-screw extruder, Int. J. Pharm. 356 (2008) 224–230. [2] M. Horibe, R. Sonoda, S. Watano, Scale-up of lubricant mixing process by using V-type blender based on discrete element method, Chem. Pharm. Bull. 66 (2018) 548–553. [7] W. De Soete, J. Dewulf, P. Cappuyns, G. Van der Vorst, B. Heirman, W. Aelterman, K. Schoetersc, H. Van Langenhove, Exergetic sustainability assessment of batch versus continuous wet granulation based pharmaceutical tablet manufacturing: a cohesive analysis at three different levels, Green Chem. 15 (2013) 3039–3048. [12] B. V. Snick, J. Holman, C. Cunningham, A. Kumar, J. Vercruysse, T. D. Beer, J. P. Remon, C. Vervaet, Continuous direct compression as manufacturing platform for sustained release tablets, Int. J. Pharm. 519 (2017) 390–407. [6] B. Ding, Pharma Industry 4.0: Literature review and research opportunities in sustainable pharmaceutical supply chains, Process Saf. Environ. Prot. 119 (2018) 115–130. [4] A. M. Agrawal, P. Pandey, Scale up of pan coating process using quality by design principles, J. Pharm. Sci. 104 (2015) 3589–3611. 11 12 13 14 15 16 1 2 3 4 5 6 7 8 9 10 |
| References_xml | – reference: [10] B. V. Melkebeke, C. Vervaet, J. P. Remon, Validation of a continuous granulation process using a twin-screw extruder, Int. J. Pharm. 356 (2008) 224–230. – reference: [13] B. V. Snick, J. Holman, V. Vanhoorne, A. Kumar, T. D. Beer, J. P. Remon, C. Vervaet, Development of a continuous direct compression platform for low-dose drug products, Int. J. Pharm. 529 (2017) 329–346. – reference: [14] M. Horibe, R. Sonoda, S. Watano, Scale-up of low drug content formulation, J. Soc. Powder. Technol. Japan 57 (2020) 12–18. – reference: [11] H. Liu, S. C. Galbraith, B. Ricart, C. Stanton, B. S. Goettler, L. Verdi, T. O’Connor, S. Lee, S. Yoon, Optimization of critical quality attributes in continuous twin-screw wet granulation via design space validated with pilot scale experimental data, Int. J. Pharm. 525 (2017) 249–263. – reference: [7] W. De Soete, J. Dewulf, P. Cappuyns, G. Van der Vorst, B. Heirman, W. Aelterman, K. Schoetersc, H. Van Langenhove, Exergetic sustainability assessment of batch versus continuous wet granulation based pharmaceutical tablet manufacturing: a cohesive analysis at three different levels, Green Chem. 15 (2013) 3039–3048. – reference: [1] H. Nakamura, H. Fujii, S. Watano, Scale-up of high shear mixer-granulator based on discrete element analysis, Powder Technol. 236 (2013) 149–156. – reference: [9] S. D. Schaber, D. I. Gerogiorgis, R. Ramachandran, J. M. B. Evans, P. I. Barton, B. L. Trout, Economic analysis of integrated continuous and batch pharmaceutical manufacturing: A case study, Ind. Eng. Chem. Res. 50 (2011) 10083–10092. – reference: [12] B. V. Snick, J. Holman, C. Cunningham, A. Kumar, J. Vercruysse, T. D. Beer, J. P. Remon, C. Vervaet, Continuous direct compression as manufacturing platform for sustained release tablets, Int. J. Pharm. 519 (2017) 390–407. – reference: [6] B. Ding, Pharma Industry 4.0: Literature review and research opportunities in sustainable pharmaceutical supply chains, Process Saf. Environ. Prot. 119 (2018) 115–130. – reference: [2] M. Horibe, R. Sonoda, S. Watano, Scale-up of lubricant mixing process by using V-type blender based on discrete element method, Chem. Pharm. Bull. 66 (2018) 548–553. – reference: [8] K. Matsunami, T. Miyano, H. Arai, H. Nakagawa, M. Hirao, H. Sugiyama, Decision support method for the choice between batch and continuous technologies in solid drug product manufacturing, Ind. Eng. Chem. Res. 57 (2018) 9798–9809. – reference: [15] Y. Kato, K. Matsumoto, M. Ohkuma, H. Sunada, Rapidly disintegrating tablets prepared by a surface-modifying method, J. Pharm. Sci. Technol. Jpn. 62 (2002) 87–94. – reference: [4] A. M. Agrawal, P. Pandey, Scale up of pan coating process using quality by design principles, J. Pharm. Sci. 104 (2015) 3589–3611. – reference: [5] S. J. Srai, C. Badman, M. Krumme, M. Futran, C. Johnston, Future supply chains enabled by continuous processing — opportunities challenges May 20–21 2014 continuous manufacturing symposium, J. Pharm. Sci. 104 (2015) 840–849. – reference: [16] Y. Zhang, K. C. Johnson, Effect of drug particle size on content uniformity of low-dose solid dosage forms, Int. J. Pharm. 154 (1997) 179–183. – reference: [3] M. Ito, S. Aoki, J. Uchiyama, K. Yamato, Development of a new punch head shape to replicate scale-up issues on a laboratory tablet press III: Replicating sticking phenomenon using the SAS punch and evaluation by checking the tablet surface using 3-D laser scanning microscope, J. Pharm. Sci. 107 (2018) 2144–2151. – ident: 3 – ident: 14 doi: 10.4164/sptj.57.12 – ident: 4 doi: 10.1002/jps.24582 – ident: 10 doi: 10.1016/j.ijpharm.2008.01.012 – ident: 16 doi: 10.1016/S0378-5173(97)00134-8 – ident: 12 doi: 10.1016/j.ijpharm.2017.01.010 – ident: 15 – ident: 11 doi: 10.1016/j.ijpharm.2017.04.055 – ident: 13 doi: 10.1016/j.ijpharm.2017.07.003 – ident: 1 doi: 10.1016/j.powtec.2012.03.009 – ident: 2 doi: 10.1248/cpb.c17-01026 – ident: 5 doi: 10.1002/jps.24343 – ident: 8 doi: 10.1021/acs.iecr.7b05230 – ident: 6 – ident: 7 – ident: 9 doi: 10.1021/ie2006752 |
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| SubjectTerms | Content uniformity Continuous manufacturing Direct compression Drug dosages Low-dose Mixing |
| Title | Development of Direct Compression Continuous Manufacturing System for Low-Dose Drug Products |
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