메뉴 건너뛰기




Volumn 18, Issue 1, 2013, Pages 85-97

Real-time assessment of critical quality attributes of a continuous granulation process

Author keywords

Continuous granulation; NIR Spectroscopy; Particle size analysis; PAT; Raman Spectroscopy

Indexed keywords

EXCIPIENT; LACTOSE; THEOPHYLLINE;

EID: 84870895675     PISSN: 10837450     EISSN: 10979867     Source Type: Journal    
DOI: 10.3109/10837450.2011.627869     Document Type: Article
Times cited : (101)

References (33)
  • 1
    • 0034755234 scopus 로고    scopus 로고
    • New trends in the production of pharmaceutical granules: Batch versus continuous processing
    • DOI 10.1016/S0939-6411(01)00199-0, PII S0939641101001990
    • Leuenberger H. New trends in the production of pharmaceutical granules: Batch versus continuous processing. Eur J Pharm Biopharm 2001;52:289-296. (Pubitemid 33033182)
    • (2001) European Journal of Pharmaceutics and Biopharmaceutics , vol.52 , Issue.3 , pp. 289-296
    • Leuenberger, H.1
  • 3
    • 0037453886 scopus 로고    scopus 로고
    • Scale-up in the 4th dimension in the field of granulation and drying or how to avoid classical scale-up
    • DOI 10.1016/S0032-5910(02)00270-X, PII S003259100200270X
    • Leuenberger, H., Scale-up in the 4th dimension in the field of granulation and drying or how to avoid classical scale-up. Powder Technol, 2003. 130: P. 225-230. (Pubitemid 36293196)
    • (2003) Powder Technology , vol.130 , Issue.1-3 , pp. 225-230
    • Leuenberger, H.1
  • 6
    • 84870914086 scopus 로고    scopus 로고
    • International Conference On Harmonisation Of Technicl Requirements For Registration Of Pharmaceuticals For Human Use cited 2011] Available from
    • International Conference on Harmonisation of Technicl Requirements for Registration of Pharmaceuticals for Human Use. Pharmaceutical Development Q8. 2009 [cited 2011]; Available from: Http://www.ich.org/fileadmin/Public-Web-Site/ ICH-Products/ Guidelines/Quality/Q8-R1/Step4/Q8-R2-Guideline.pdf
    • (2009) Pharmaceutical Development , vol.Q8
  • 7
    • 84870860735 scopus 로고    scopus 로고
    • International Conference On Harmonisation Of Technical Requirements Of Regeistration Of Pharmaceuticals For Human Use cited 2011] Available from
    • International Conference on Harmonisation of Technical Requirements of Regeistration of Pharmaceuticals for Human Use. Quality Risk Management Q9. 2005 [cited 2011]; Available from: Http://www.ich.org/fileadmin/Public-Web-Site/ICH- Products/ Guidelines/Quality/Q9/Step4/Q9-Guideline.pdf
    • (2005) Quality Risk Management , vol.Q9
  • 8
    • 84870883219 scopus 로고    scopus 로고
    • International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use cited 2011] Available from
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Pharmaceutical Quality System Q10. 2008 [cited 2011]; Available from: Http://www.ich.org/fileadmin/Public-Web- Site/ICH-Products/ Guidelines/Quality/Q10/Step4/Q10-Guideline.pdf
    • (2008) Pharmaceutical Quality System , vol.Q10
  • 10
    • 0023000410 scopus 로고
    • Continuous extrusion using a Baker Perkins MP50 (multipurpose) extruder
    • Gamlen, MJ and Eardley C., Continuous extrusion using a baker perkins mp50 (multipurpose) extruder. Drug Dev Ind Pharm, 1986. 12:1701-1713. (Pubitemid 17178841)
    • (1986) Drug Development and Industrial Pharmacy , vol.12 , Issue.11-13 , pp. 1701-1713
    • Gamlen, M.J.1    Eardley, C.2
  • 11
    • 0000993432 scopus 로고
    • Extrusion of an effervescent granulation with a twin screw extruder baker perkins mpf 50-D
    • Lindberg, NO, Tufvesson C., and Olbjer L. Extrusion of an effervescent granulation with a twin screw extruder, baker perkins mpf 50-D. Drug DevIndPharm, 1987. 13: 1891-1913.
    • (1987) Drug DevIndPharm , vol.13 , pp. 1891-1913
    • Lindberg, N.O.1    Tufvesson, C.2    Olbjer, L.3
  • 12
    • 2342614829 scopus 로고    scopus 로고
    • Semicontinuous granulation - The process of choice for the production of pharmaceutical granules?
    • DOI 10.1016/j.powtec.2004.01.021, PII S0032591004000415
    • Werani, J., et al., Semicontinuous granulation - The process of choice for the production of pharmaceutical granules? Powder Technol, 2004. 140: 163-168. (Pubitemid 38608996)
    • (2004) Powder Technology , vol.140 , Issue.3 , pp. 163-168
    • Werani, J.1    Grunberg, M.2    Ober, C.3    Leuenberger, H.4
  • 13
    • 0042344952 scopus 로고    scopus 로고
    • Batch and continuous processing in the production of pharmaceutical granules
    • DOI 10.1081/PDT-120022157
    • Betz G, Junker-Bürgin P, Leuenberger H. Batch and continuous processing in the production of pharmaceutical granules. Pharm Dev Technol 2003;8:289-297. (Pubitemid 36900235)
    • (2003) Pharmaceutical Development and Technology , vol.8 , Issue.3 , pp. 289-297
    • Betz, G.1    Junker-Burgin, P.2    Leuenberger, H.3
  • 15
    • 18644363185 scopus 로고    scopus 로고
    • Continuous granulation in the pharmaceutical industry
    • DOI 10.1016/j.ces.2005.02.028, PII S0009250905001284
    • Vervaet, C., and Remon JP. Continuous granulation in the pharmaceutical industry. Chemical Engineering Science, 2005. 60: 3949-3957. (Pubitemid 40665423)
    • (2005) Chemical Engineering Science , vol.60 , Issue.14 , pp. 3949-3957
    • Vervaet, C.1    Remon, J.P.2
  • 16
    • 0037018970 scopus 로고    scopus 로고
    • Continuous twin screw extrusion for the wet granulation of lactose
    • DOI 10.1016/S0378-5173(02)00052-2, PII S0378517302000522
    • Keleb EI, Vermeire A, Vervaet C, Remon JP. Continuous twin screw extrusion for the wet granulation of lactose. Int J Pharm 2002;239:69-80. (Pubitemid 34615796)
    • (2002) International Journal of Pharmaceutics , vol.239 , Issue.1-2 , pp. 69-80
    • Keleb, E.I.1    Vermeire, A.2    Vervaet, C.3    Remon, J.P.4
  • 17
    • 1542268927 scopus 로고    scopus 로고
    • Twin screw granulation as a simple and efficient tool for continuous wet granulation
    • DOI 10.1016/j.ijpharm.2004.01.001, PII S0378517304000122
    • Keleb EI, Vermeire A, Vervaet C, Remon JP. Twin screw granulation as a simple and efficient tool for continuous wet granulation. Int J Pharm 2004;273:183-194. (Pubitemid 38317051)
    • (2004) International Journal of Pharmaceutics , vol.273 , Issue.1-2 , pp. 183-194
    • Keleb, E.I.1    Vermeire, A.2    Vervaet, C.3    Remon, J.P.4
  • 18
    • 42649100966 scopus 로고    scopus 로고
    • Validation of a continuous granulation process using a twin-Screw extruder
    • Van Melkebeke B, Vervaet C, Remon JP. Validation of a continuous granulation process using a twin-Screw extruder. Int J Pharm 2008;356:224-230.
    • (2008) Int J Pharm , vol.356 , pp. 224-230
    • Van Melkebeke, B.1    Vervaet, C.2    Remon, J.P.3
  • 20
    • 0002026991 scopus 로고
    • Fluidised bed granulation - factors inuencing the quality of the product
    • Aulton, ME and Banks, M. Fluidised bed granulation - factors inuencing the quality of the product. Int J Pharm Technol Prod Manuf, 1981. 2: 24-29.
    • (1981) Int J Pharm Technol Prod Manuf , vol.2 , pp. 24-29
    • Aulton, M.E.1    Banks, M.2
  • 21
    • 0023225538 scopus 로고
    • Granulation - A review of pharmaceutical wet-granulation
    • Kristensen, HG and Schaefer T. Granulation - A review of pharmaceutical wet-granulation. Drug Dev Ind Phar, 1987. 13: 803-872.
    • (1987) Drug Dev Ind Phar , vol.13 , pp. 803-872
    • Kristensen, H.G.1    Schaefer, T.2
  • 24
    • 85047682766 scopus 로고    scopus 로고
    • Analysis of solid-State transformations of pharmaceutical compounds using vibrational spectroscopy
    • Heinz A, Strachan CJ, Gordon KC, Rades T. Analysis of solid-State transformations of pharmaceutical compounds using vibrational spectroscopy. J Pharm Pharmacol 2009;61:971-988.
    • (2009) J Pharm Pharmacol , vol.61 , pp. 971-988
    • Heinz, A.1    Strachan, C.J.2    Gordon, K.C.3    Rades, T.4
  • 27
    • 12244274356 scopus 로고    scopus 로고
    • In-line monitoring of hydrate formation during wet granulation using Raman spectroscopy
    • DOI 10.1002/jps.20241
    • Wikström H, Marsac PJ, Taylor LS. In-line monitoring of hydrate formation during wet granulation using Raman spectroscopy. J Pharm Sci 2005;94:209-219. (Pubitemid 40116384)
    • (2005) Journal of Pharmaceutical Sciences , vol.94 , Issue.1 , pp. 209-219
    • Wikstrom, H.1    Marsac, P.J.2    Taylor, L.S.3
  • 28
    • 77955661712 scopus 로고    scopus 로고
    • Evaluation of in-line spatial filter velocimetry as PAT monitoring tool for particle growth during fluid bed granulation
    • Burggraeve A, Van Den Kerkhof T, Hellings M, Remon JP, Vervaet C, De Beer T. Evaluation of in-line spatial filter velocimetry as PAT monitoring tool for particle growth during fluid bed granulation. Eur J Pharm Biopharm 2010;76:138-146.
    • (2010) Eur J Pharm Biopharm , vol.76 , pp. 138-146
    • Burggraeve, A.1    Van Den Kerkhof, T.2    Hellings, M.3    Remon, J.P.4    Vervaet, C.5    De Beer, T.6
  • 30
    • 0037168237 scopus 로고    scopus 로고
    • Application of slurry bridging experiments at controlled water activities to predict the solid-state conversion between anhydrous and hydrated forms using theophylline as a model drug
    • DOI 10.1016/S0378-5173(02)00277-6, PII S0378517302002776
    • Ticehurst MD, Storey RA, Watt C. Application of slurry bridging experiments at controlled water activities to predict the solidstate conversion between anhydrous and hydrated forms using theophylline as a model drug. Int J Pharm 2002;247:1-10. (Pubitemid 35341134)
    • (2002) International Journal of Pharmaceutics , vol.247 , Issue.1-2 , pp. 1-10
    • Ticehurst, M.D.1    Storey, R.A.2    Watt, C.3
  • 32
    • 1042298067 scopus 로고    scopus 로고
    • Phase transformation considerations during process development and manufacture of solid oral dosage forms
    • DOI 10.1016/j.addr.2003.10.009
    • Zhang GG, Law D, Schmitt EA, Qiu Y. Phase transformation considerations during process development and manufacture of solid oral dosage forms. Adv Drug Deliv Rev 2004;56:371-390. (Pubitemid 38202329)
    • (2004) Advanced Drug Delivery Reviews , vol.56 , Issue.3 , pp. 371-390
    • Zhang, G.G.Z.1    Law, D.2    Schmitt, E.A.3    Qiu, Y.4
  • 33
    • 59449105275 scopus 로고    scopus 로고
    • Noninvasive in situ identification and band assignments of some pharmaceutical excipients inside USP vials with FT-near-infrared spectroscopy
    • Ali HR, Edwards HG, Scowen IJ. Noninvasive in situ identification and band assignments of some pharmaceutical excipients inside USP vials with FT-near-infrared spectroscopy. Spectrochim Acta A Mol Biomol Spectrosc 2009;72:890-896.
    • (2009) Spectrochim Acta A Mol Biomol Spectrosc , vol.72 , pp. 890-896
    • Ali, H.R.1    Edwards, H.G.2    Scowen, I.J.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.