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Pharmaceutical Development and Technology Volume 11, 2006 - Issue 3
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Research Article

Evaluation of Risk and Benefit in the Implementation of Near-Infrared Spectroscopy for Monitoring of Lubricant Mixing

Arwa S. El Hagrasy Process Analytical Technology Group, Pharmaceutical Development Center of Excellence, Pharmaceutical Research Institute, Bristol-Myers Squibb, New Brunswick, New Jersey, USA
,
Shih-Ying Chang Process Analytical Technology Group, Pharmaceutical Development Center of Excellence, Pharmaceutical Research Institute, Bristol-Myers Squibb, New Brunswick, New Jersey, USA
&
San Kiang Process Analytical Technology Group, Pharmaceutical Development Center of Excellence, Pharmaceutical Research Institute, Bristol-Myers Squibb, New Brunswick, New Jersey, USA
Pages 303-312 | Received 29 Oct 2005, Accepted 17 Dec 2005, Published online: 07 Oct 2008

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P. Barrocas, A. C. F Vieira, H. Almeida, J. Teixeira, M. J. Gomes, E. Chevalier, P. Soares-da-Silva & T. Vasconcelos. (2023) Over-blending effect of lubricants on capsules manufacturing: a simple and fast wettability technique to predict batch dissolution performance. Pharmaceutical Development and Technology 28:3-4, pages 363-370.
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Alexander Lewis Bowler, Serafim Bakalis & Nicholas James Watson. (2020) A review of in-line and on-line measurement techniques to monitor industrial mixing processes. Chemical Engineering Research and Design 153, pages 463-495.
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Masafumi Dohi, Wataru MomoseKazunari YamashitaTadashi HakomoriShusaku Sato, Shuji Noguchi & Katsuhide Terada. (2017) Application of Terahertz Attenuated Total Reflection Spectroscopy to Detect Changes in the Physical Properties of Lactose during the Lubrication Process Required for Drug Formulation. CHEMICAL & PHARMACEUTICAL BULLETIN Chemical and Pharmaceutical Bulletin 65:2, pages 186-193.
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Claudia Corredor. 2016. Pharmaceutical Excipients. Pharmaceutical Excipients 303 327 .
Margot Fonteyne, Jurgen Vercruysse, Fien De Leersnyder, Rut Besseling, Ad Gerich, Wim Oostra, Jean Paul Remon, Chris Vervaet & Thomas De Beer. (2016) Blend uniformity evaluation during continuous mixing in a twin screw granulator by in-line NIR using a moving F-test. Analytica Chimica Acta 935, pages 213-223.
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Barbara Bakri, Marco Weimer, Gerrit Hauck & Gabriele Reich. (2015) Assessment of powder blend uniformity: Comparison of real-time NIR blend monitoring with stratified sampling in combination with HPLC and at-line NIR Chemical Imaging. European Journal of Pharmaceutics and Biopharmaceutics 97, pages 78-89.
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An-Ni Huang & Hsiu-Po Kuo. (2014) Developments in the tools for the investigation of mixing in particulate systems – A review. Advanced Powder Technology 25:1, pages 163-173.
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Donald S. Risley, Lars-Erik Magnusson, Paul R. Morow & Aktham Aburub. (2013) Analysis of magnesium from magnesium stearate in pharmaceutical tablet formulations using hydrophilic interaction liquid chromatography with nano quantity analyte detection. Journal of Pharmaceutical and Biomedical Analysis 78-79, pages 112-117.
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Hiroshi Nakagawa, Manabu Kano, Shinji Hasebe, Tatsuya Suzuki & Naoki Wakiyama. (2013) Real-time monitoring of lubrication properties of magnesium stearate using NIR spectrometer and thermal effusivity sensor. International Journal of Pharmaceutics 441:1-2, pages 402-413.
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Joshua Müller, Daniela Brock, Klaus Knop, J. Axel Zeitler & Peter Kleinebudde. (2012) Prediction of dissolution time and coating thickness of sustained release formulations using Raman spectroscopy and terahertz pulsed imaging. European Journal of Pharmaceutics and Biopharmaceutics 80:3, pages 690-697.
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Marcelo Blanco, Ruben Cueva-Mestanza & Jordi Cruz. (2012) Critical evaluation of methods for end-point determination in pharmaceutical blending processes. Analytical Methods 4:9, pages 2694.
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T. De Beer, A. Burggraeve, M. Fonteyne, L. Saerens, J.P. Remon & C. Vervaet. (2011) Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes. International Journal of Pharmaceutics 417:1-2, pages 32-47.
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M. Perrault, F. Bertrand & J. Chaouki. (2010) An investigation of magnesium stearate mixing in a V-blender through gamma-ray detection. Powder Technology 200:3, pages 234-245.
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Brandye Smith-Goettler. 2010. Process Analytical Technology. Process Analytical Technology 439 461 .
Tomoaki Sakamoto, Keiko Mizukai, Toru Kawanishi & Yukio Hiyama. (2009) Real-Time Analysis for Quality Control of a Reaction Process using Ultra-high Performance Liquid Chromatography. Reduction of Phenyl Ketone to Phenyl Alcohol. Journal of Pharmaceutical Innovation 4:3, pages 115-120.
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Keiichi Sugisawa, Takashi Kaneko, Tsuyoshi Sago & Tomonobu Sato. (2009) Rapid quantitative analysis of magnesium stearate in pharmaceutical powders and solid dosage forms by atomic absorption: Method development and application in product manufacturing. Journal of Pharmaceutical and Biomedical Analysis 49:3, pages 858-861.
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Masatomo Ito, Tatsuya Suzuki, Shuichi Yada, Akira Kusai, Hiroaki Nakagami, Etsuo Yonemochi & Katsuhide Terada. (2008) Development of a method for the determination of caffeine anhydrate in various designed intact tables by near-infrared spectroscopy: A comparison between reflectance and transmittance technique. Journal of Pharmaceutical and Biomedical Analysis 47:4-5, pages 819-827.
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