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Research Article

Quantifying Low Amorphous or Crystalline Amounts of Alpha‐Lactose‐Monohydrate Using X‐Ray Powder Diffraction, Near‐Infrared Spectroscopy, and Differential Scanning Calorimetry

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Pages 513-523 | Published online: 25 May 2004

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M. Dandignac, S. P. Lacerda, A. Chamayou & L. Galet. (2022) Comparison study of physicochemical and biopharmaceutics properties of hydrophobic drugs ground by two dry milling processes. Pharmaceutical Development and Technology 27:7, pages 816-828.
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Futoshi Shikata, Susumu Kimura, Yusuke Hattori & Makoto Otsuka. (2018) Application of near-infrared spectroscopy to optimize dissolution profiles of tablets according to the granulation mechanism. Drug Development and Industrial Pharmacy 44:5, pages 713-722.
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Thao M. Ho, Tuyen Truong & Bhesh R. Bhandari. (2017) Methods to characterize the structure of food powders – a review. Bioscience, Biotechnology, and Biochemistry 81:4, pages 651-671.
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Luis Padrela, Edmundo Gomes de Azevedo & Sitaram P. Velaga. (2012) Powder X-ray diffraction method for the quantification of cocrystals in the crystallization mixture. Drug Development and Industrial Pharmacy 38:8, pages 923-929.
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Orsolya Jójárt-Laczkovich & Piroska Szabó-Révész. (2011) Formulation of tablets containing an ‘in-process’ amorphized active pharmaceutical ingredient. Drug Development and Industrial Pharmacy 37:11, pages 1272-1281.
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Yuya Fukui & Makoto Otsuka. (2010) Determination of the crystallinity of cephalexin in pharmaceutical formulations by chemometrical near-infrared spectroscopy. Drug Development and Industrial Pharmacy 36:1, pages 72-80.
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Radha R. Vippagunta, Changkang Pan, Ronak Vakil, Vindhya Meda, Richard Vivilecchia & Michael Motto. (2009) Application of surface area measurement for identifying the source of batch-to-batch variation in processability. Pharmaceutical Development and Technology 14:5, pages 492-498.
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Pauline H.M. Janssen, Lorina M.N. Bisharat & Marly Bastiaansen. (2023) Complexities related to the amorphous content of lactose carriers. International Journal of Pharmaceutics: X 6, pages 100216.
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Tzuyi L. Yang, Melpomeni Stogiannari, Sylwia Janeczko, Marva Khoshan, Yueyuan Lin, Abdullah Isreb, Rober Habashy, Joanna Giebułtowicz, Matthew Peak & Mohamed A. Alhnan. (2023) Towards point-of-care manufacturing and analysis of immediate-release 3D printed hydrocortisone tablets for the treatment of congenital adrenal hyperplasia. International Journal of Pharmaceutics 642, pages 123072.
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Thamer Alzoubi, Gary P. Martin, David J. Barlow & Paul G. Royall. (2021) Stability of α-lactose monohydrate: The discovery of dehydration triggered solid-state epimerization. International Journal of Pharmaceutics 604, pages 120715.
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Fanghui Fan, Pengyu Xiang & Liqing Zhao. (2021) Vibrational spectra analysis of amorphous lactose in structural transformation: Water/temperature plasticization, crystal formation, and molecular mobility. Food Chemistry 341, pages 128215.
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Laura Dall Olio, Silvia Spinozzi, Marco Curzi, Enrico Modena & Lucia Maini. (2020) Direct derivation of the crystalline fraction of highly potent active pharmaceutical ingredients by X-ray powder diffraction. European Journal of Pharmaceutical Sciences, pages 105692.
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Anyi Wang, Jun Lin & Qixin Zhong. (2020) Physical and microbiological properties of powdered Lactobacillus salivarius NRRL B-30514 as affected by relative amounts of dairy proteins and lactose. LWT 121, pages 109044.
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Anyi Wang, Jun Lin & Qixin Zhong. (2020) Probiotic powders prepared by mixing suspension of Lactobacillus salivarius NRRL B-30514 and spray-dried lactose: Physical and microbiological properties. Food Research International 127, pages 108706.
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Solveig Warnecke, Jian X. Wu, Åsmund Rinnan, Morten Allesø, Frans van den Berg, Peter Uhd Jepsen & Søren Balling Engelsen. (2019) Quantifying crystalline α-lactose monohydrate in amorphous lactose using terahertz time domain spectroscopy and near infrared spectroscopy. Vibrational Spectroscopy 102, pages 39-46.
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Kevin DeBoyace, Ira S. Buckner, Yuchuan Gong, Tzu-chi Rob Ju & Peter L.D. Wildfong. (2018) Modeling and Prediction of Drug Dispersability in Polyvinylpyrrolidone-Vinyl Acetate Copolymer Using a Molecular Descriptor. Journal of Pharmaceutical Sciences 107:1, pages 334-343.
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Natalia L. Calvo, Rubén M. Maggio & Teodoro S. Kaufman. (2018) Chemometrics-assisted solid-state characterization of pharmaceutically relevant materials. Polymorphic substances. Journal of Pharmaceutical and Biomedical Analysis 147, pages 518-537.
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Rahul B. Chavan, Nallamothu Bhargavi, Anurag Lodagekar & Nalini R. Shastri. (2017) Near infra red spectroscopy: a tool for solid state characterization. Drug Discovery Today 22:12, pages 1835-1843.
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Samaneh Pazesh, Lucia Lazorova, Jonas Berggren, Göran Alderborn & Johan Gråsjö. (2016) Considerations on the quantitative analysis of apparent amorphicity of milled lactose by Raman spectroscopy. International Journal of Pharmaceutics 511:1, pages 488-504.
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Gabriele Reich. 2016. Analytical Techniques in the Pharmaceutical Sciences. Analytical Techniques in the Pharmaceutical Sciences 61 138 .
Paul E. Luner & Jeffery J. Seyer. (2014) Assessment of Crystallinity in Processed Sucrose by Near‐Infrared Spectroscopy and Application to Lyophiles. Journal of Pharmaceutical Sciences 103:9, pages 2884-2895.
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Duohai Pan, George Crull, Shawn Yin & John Grosso. (2014) Low level drug product API form analysis – Avalide tablet NIR quantitative method development and robustness challenges. Journal of Pharmaceutical and Biomedical Analysis 89, pages 268-275.
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Yusuke Hattori & Makoto Otsuka. (2012) Time-resolved near-infrared spectroscopic study of the dissolution of crystalline lactose. European Journal of Pharmaceutical Sciences 47:5, pages 884-889.
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Syed Anuar Faua’ad Syed Muhammad, Patricia Tang, Hak-Kim Chan & Fariba Dehghani. (2012) The effect of lactose micro-spherical crystals prepared by conditioning with supercritical fluid on salbutamol sulphate inhalation performance. The Journal of Supercritical Fluids 71, pages 92-101.
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Ryanne N. Palermo, Steven M. Short, Carl A. Anderson, Hung Tian & James K. DrennenIIIIII. (2012) Determination of Figures of Merit for Near-Infrared, Raman and Powder X-ray Diffraction by Net Analyte Signal Analysis for a Compacted Amorphous Dispersion with Spiked Crystallinity. Journal of Pharmaceutical Innovation 7:2, pages 56-68.
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Alfred C.F. Rumondor & Lynne S. Taylor. (2010) Application of Partial Least-Squares (PLS) modeling in quantifying drug crystallinity in amorphous solid dispersions. International Journal of Pharmaceutics 398:1-2, pages 155-160.
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Minna Lappalainen & Maarit Karppinen. (2010) Techniques of differential scanning calorimetry for quantification of low contents of amorphous phases. Journal of Thermal Analysis and Calorimetry 102:1, pages 171-180.
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Xiaoming Chen, Joseph G. Stowell, Kenneth R. Morris & Stephen R. Byrn. (2010) Quantitative study of solid-state acid–base reactions between polymorphs of flufenamic acid and magnesium oxide using X-ray powder diffraction. Journal of Pharmaceutical and Biomedical Analysis 51:4, pages 866-874.
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Michael D. Moore, Robert P. Cogdill & Peter L.D. Wildfong. (2009) Evaluation of chemometric algorithms in quantitative X-ray powder diffraction (XRPD) of intact multi-component consolidated samples. Journal of Pharmaceutical and Biomedical Analysis 49:3, pages 619-626.
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Yuan Listiohadi, James Arthur Hourigan, Robert Walter Sleigh & Robert John Steele. (2008) Thermal analysis of amorphous lactose and α-lactose monohydrate. Dairy Science and Technology 89:1, pages 43-67.
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Paul T. Whiteside, Shen Y. Luk, Claire E. Madden-Smith, Paul Turner, Nikin Patel & Michael W. George. (2008) Detection of Low Levels of Amorphous Lactose using H/D Exchange and FT-Raman Spectroscopy. Pharmaceutical Research 25:11, pages 2650-2656.
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S. Garnier, S. Petit, F. Mallet, M.-N. Petit, D. Lemarchand, S. Coste, J. Lefebvre & G. Coquerel. (2008) Influence of ageing, grinding and preheating on the thermal behaviour of α-lactose monohydrate. International Journal of Pharmaceutics 361:1-2, pages 131-140.
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Danielle Giron, S. Monnier, M. Mutz, P. Piechon, T. Buser, F. Stowasser, K. Schulze & M. Bellus. (2007) Comparison of quantitative methods for analysis of polyphasic pharmaceuticals. Journal of Thermal Analysis and Calorimetry 89:3, pages 729-743.
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Yves Roggo, Pascal Chalus, Lene Maurer, Carmen Lema-Martinez, Aurélie Edmond & Nadine Jent. (2007) A review of near infrared spectroscopy and chemometrics in pharmaceutical technologies. Journal of Pharmaceutical and Biomedical Analysis 44:3, pages 683-700.
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Shigeo Yamamura, Rieko Takahira & Yasunori Momose. (2007) Crystallization Kinetics of Amorphous Griseofulvin by Pattern Fitting Procedure Using X-Ray Diffraction Data. Pharmaceutical Research 24:5, pages 880-887.
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Vesa-Pekka Lehto, Mikko Tenho, Kalle V?h?-Heikkil?P?ivi Harjunen, Maarit P??llysaho, Jouni V?lisaari, Pentti Niemel?Kristiina J?rvinen. (2006) The comparison of seven different methods to quantify the amorphous content of spray dried lactose. Powder Technology 167:2, pages 85-93.
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