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Volumn 41, Issue 1, 2010, Pages 156-162

Digital imaging as a process analytical technology tool for fluid-bed pellet coating process

Author keywords

Digital imaging; Pellet coating process; Process analytical technology; Quality control

Indexed keywords

ANALYTIC METHOD; ARTICLE; DIGITAL IMAGING; DRUG COATING; DRUG PELLET; DRUG STABILITY; PRIORITY JOURNAL; CHEMISTRY; MEDICINAL CHEMISTRY;

EID: 77954757339     PISSN: 09280987     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejps.2010.06.001     Document Type: Article
Times cited : (39)

References (26)
  • 1
    • 0033954050 scopus 로고    scopus 로고
    • Analysis of film coating thickness and surface area of pharmaceutical pellets using fluorescence microscopy and image analysis
    • Andersson M., Holmquist B., Lindquist J., Nilsson O., Wahlund K.G. Analysis of film coating thickness and surface area of pharmaceutical pellets using fluorescence microscopy and image analysis. J. Pharm. Biomed. Anal. 2000, 22:325-339.
    • (2000) J. Pharm. Biomed. Anal. , vol.22 , pp. 325-339
    • Andersson, M.1    Holmquist, B.2    Lindquist, J.3    Nilsson, O.4    Wahlund, K.G.5
  • 3
    • 0035253520 scopus 로고    scopus 로고
    • An improved method for the measurement of colour uniformity in pellet coating
    • Chan L.W., Chan W.Y., Heng P.W.S. An improved method for the measurement of colour uniformity in pellet coating. Int. J. Pharm. 2001, 213:63-74.
    • (2001) Int. J. Pharm. , vol.213 , pp. 63-74
    • Chan, L.W.1    Chan, W.Y.2    Heng, P.W.S.3
  • 5
    • 0037018965 scopus 로고    scopus 로고
    • The influence of pellet shape and surface properties on the drug release from uncoated and coated pellets
    • Chopra R., Alderborn G., Podczeck F., Newton J.M. The influence of pellet shape and surface properties on the drug release from uncoated and coated pellets. Int. J. Pharm. 2002, 239:171-178.
    • (2002) Int. J. Pharm. , vol.239 , pp. 171-178
    • Chopra, R.1    Alderborn, G.2    Podczeck, F.3    Newton, J.M.4
  • 6
    • 0000948063 scopus 로고
    • A method of assigning numerical and percentage values to the degree of roundness of sand grains
    • Cox E.P. A method of assigning numerical and percentage values to the degree of roundness of sand grains. J. Paleontol. 1927, 1:179-183.
    • (1927) J. Paleontol. , vol.1 , pp. 179-183
    • Cox, E.P.1
  • 7
    • 33644663961 scopus 로고    scopus 로고
    • Process analytical technologies in the pharmaceutical industry: the FDA's PAT initiative
    • Hinz D.C. Process analytical technologies in the pharmaceutical industry: the FDA's PAT initiative. Anal. Bioanal. Chem. 2006, 384:1036-1042.
    • (2006) Anal. Bioanal. Chem. , vol.384 , pp. 1036-1042
    • Hinz, D.C.1
  • 8
    • 77954759335 scopus 로고    scopus 로고
    • HSS (U.S. Department of Health and Human Services), FDA (Food and Drug Administration), CDER (Center for Drug Evaluation and Research), CVM (Center for Veterinary Medicine), ORA (Office of Regulatory Affairs), 2004. Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance.
    • HSS (U.S. Department of Health and Human Services), FDA (Food and Drug Administration), CDER (Center for Drug Evaluation and Research), CVM (Center for Veterinary Medicine), ORA (Office of Regulatory Affairs), 2004. Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance.
  • 9
    • 77954758165 scopus 로고    scopus 로고
    • ICH - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 1996. ICH guidelines Q2A and Q2B: Validation of Analytical procedures: Text and methodology.
    • ICH - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 1996. ICH guidelines Q2A and Q2B: Validation of Analytical procedures: Text and methodology.
  • 11
    • 0031392533 scopus 로고    scopus 로고
    • Preliminary assessment of an image analysis method for the evaluation of pharmaceutical coatings
    • Kennedy J.P., Niebergall P.J. Preliminary assessment of an image analysis method for the evaluation of pharmaceutical coatings. Pharm. Dev. Technol. 1997, 3:205-212.
    • (1997) Pharm. Dev. Technol. , vol.3 , pp. 205-212
    • Kennedy, J.P.1    Niebergall, P.J.2
  • 12
    • 0030045439 scopus 로고    scopus 로고
    • Near-infrared spectroscopic monitoring of the film coating process
    • Kirsch J.D., Drennen J.K. Near-infrared spectroscopic monitoring of the film coating process. Pharm. Res. 1996, 13:234-237.
    • (1996) Pharm. Res. , vol.13 , pp. 234-237
    • Kirsch, J.D.1    Drennen, J.K.2
  • 13
    • 0346494406 scopus 로고    scopus 로고
    • New perspectives for visual characterization of pharmaceutical solids
    • Laitinen N., Antikainen O., Rantanen J., Yliruusi J. New perspectives for visual characterization of pharmaceutical solids. J. Pharm. Sci. 2004, 93:165-176.
    • (2004) J. Pharm. Sci. , vol.93 , pp. 165-176
    • Laitinen, N.1    Antikainen, O.2    Rantanen, J.3    Yliruusi, J.4
  • 14
    • 0037312658 scopus 로고    scopus 로고
    • Validation of an image analysis method for estimating coating thickness on pellets
    • Larsen C.C., Sonnergaard J.M., Bertelsen P., Holm P. Validation of an image analysis method for estimating coating thickness on pellets. Eur. J. Pharm. Sci. 2003, 18:191-196.
    • (2003) Eur. J. Pharm. Sci. , vol.18 , pp. 191-196
    • Larsen, C.C.1    Sonnergaard, J.M.2    Bertelsen, P.3    Holm, P.4
  • 15
    • 67349092971 scopus 로고    scopus 로고
    • Moisture content determination of pharmaceutical pellets by near infrared spectroscopy: method development and validation
    • Mantanus J., Ziemons E., Lebrun P., Rozet E., Klinkenberg R., Streel B., Evrard B., Hubert P. Moisture content determination of pharmaceutical pellets by near infrared spectroscopy: method development and validation. Anal. Chim. Acta 2009, 642:186-192.
    • (2009) Anal. Chim. Acta , vol.642 , pp. 186-192
    • Mantanus, J.1    Ziemons, E.2    Lebrun, P.3    Rozet, E.4    Klinkenberg, R.5    Streel, B.6    Evrard, B.7    Hubert, P.8
  • 16
    • 44849105866 scopus 로고    scopus 로고
    • A new rapid on-line imaging method to determine particle size distribution of granules
    • Naervaenen T., Seppaelae K., Antikainen O., Yliruusi J. A new rapid on-line imaging method to determine particle size distribution of granules. AAPS PharmSciTech. 2008, 9:282-287.
    • (2008) AAPS PharmSciTech. , vol.9 , pp. 282-287
    • Naervaenen, T.1    Seppaelae, K.2    Antikainen, O.3    Yliruusi, J.4
  • 17
    • 27844500635 scopus 로고    scopus 로고
    • Quantitative analysis of film coating in a pan coater based on in-line sensor measurements
    • Perez-Ramos J.D., Findlay W.P., Peck G., Morris K.R. Quantitative analysis of film coating in a pan coater based on in-line sensor measurements. AAPS PharmSciTech. 2005, 6:127-136.
    • (2005) AAPS PharmSciTech. , vol.6 , pp. 127-136
    • Perez-Ramos, J.D.1    Findlay, W.P.2    Peck, G.3    Morris, K.R.4
  • 18
    • 0032732921 scopus 로고    scopus 로고
    • Evaluation of a standardised procedure to assess the shape of pellets using image analysis
    • Podczeck F., Rahman S.R., Newton J.M. Evaluation of a standardised procedure to assess the shape of pellets using image analysis. Int. J. Pharm. 1999, 192:123-138.
    • (1999) Int. J. Pharm. , vol.192 , pp. 123-138
    • Podczeck, F.1    Rahman, S.R.2    Newton, J.M.3
  • 20
    • 20444399524 scopus 로고    scopus 로고
    • Near-infrared spectroscopy and imaging: basic principles and pharmaceutical applications
    • Reich G. Near-infrared spectroscopy and imaging: basic principles and pharmaceutical applications. Adv. Drug Deliv. Rev. 2005, 57:1109-1143.
    • (2005) Adv. Drug Deliv. Rev. , vol.57 , pp. 1109-1143
    • Reich, G.1
  • 22
    • 23444460875 scopus 로고    scopus 로고
    • The influence of pellet shape, size and distribution on capsule filling - a preliminary evaluation of three-dimensional computer simulation using a Monte-Carlo technique
    • Rowe R.C., York P., Colbourn E.A., Roskilly S.J. The influence of pellet shape, size and distribution on capsule filling - a preliminary evaluation of three-dimensional computer simulation using a Monte-Carlo technique. Int. J. Pharm. 2005, 300:32-37.
    • (2005) Int. J. Pharm. , vol.300 , pp. 32-37
    • Rowe, R.C.1    York, P.2    Colbourn, E.A.3    Roskilly, S.J.4
  • 23
    • 0034194380 scopus 로고    scopus 로고
    • Identification and characterization of factors controlling tablet coating uniformity in a Wurster coating process
    • Shelukar S., Ho J., Zega J., Roland E., Yeh N., Quiram D., Nole A., Katdare A., Reynolds S. Identification and characterization of factors controlling tablet coating uniformity in a Wurster coating process. Powder Technol. 2000, 110:29-36.
    • (2000) Powder Technol. , vol.110 , pp. 29-36
    • Shelukar, S.1    Ho, J.2    Zega, J.3    Roland, E.4    Yeh, N.5    Quiram, D.6    Nole, A.7    Katdare, A.8    Reynolds, S.9
  • 24
    • 39949083193 scopus 로고    scopus 로고
    • Content uniformity determination of pharmaceutical tablets using five near-infrared reflectance spectrometers: a process analytical technology (PAT) approach using robust multivariate calibration transfer algorithms
    • Sulub Y., LoBrutto R., Vivilecchia R., Wabuyele B.W. Content uniformity determination of pharmaceutical tablets using five near-infrared reflectance spectrometers: a process analytical technology (PAT) approach using robust multivariate calibration transfer algorithms. Anal. Chim. Acta 2008, 611:143-150.
    • (2008) Anal. Chim. Acta , vol.611 , pp. 143-150
    • Sulub, Y.1    LoBrutto, R.2    Vivilecchia, R.3    Wabuyele, B.W.4
  • 25
    • 0042855507 scopus 로고    scopus 로고
    • The granulation process 101, basic technologies for tablet making
    • Tousey M.D. The granulation process 101, basic technologies for tablet making. Pharm. Technol. (Tableting and Granulation) 2002, 1:8-13.
    • (2002) Pharm. Technol. (Tableting and Granulation) , vol.1 , pp. 8-13
    • Tousey, M.D.1
  • 26
    • 0035806248 scopus 로고    scopus 로고
    • Direct control of wet granulation processes by image processing system
    • Watano S. Direct control of wet granulation processes by image processing system. Powder Technol. 2001, 117:163-172.
    • (2001) Powder Technol. , vol.117 , pp. 163-172
    • Watano, S.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.