Visualization and prediction of porosity in roller compacted ribbons with near-infrared chemical imaging (NIR-CI).

The porosity of roller compacted ribbon is recognized as an important critical quality attribute which has a huge impact on the final product quality. The purpose of this study was to investigate the use of near-infrared chemical imaging (NIR-CI) for porosity estimation of ribbons produced at different roll pressures. Two off-line methods were utilized as reference methods. The relatively fast method (oil absorption) was comparable with the more time-consuming mercury intrusion method (R(2)=0.98). Therefore, the oil method was selected as the reference off line method. It was confirmed by both reference methods that ribbons compressed at a higher pressure resulted in a lower mean porosity. Using NIR-CI in combination with multivariate data analysis it was possible to visualize and predict the porosity distribution of the ribbons. This approach is considered important for process monitoring and control of continuously operating roller compaction line.

[1]  Hans Leuenberger,et al.  Terahertz pulsed imaging and near infrared imaging to monitor the coating process of pharmaceutical tablets. , 2009, International journal of pharmaceutics.

[2]  P. Bertelsen,et al.  Improving the compaction properties of roller compacted calcium carbonate. , 2007, International journal of pharmaceutics.

[3]  A. Samanta,et al.  Application of Near-Infrared Spectroscopy in Real-Time Monitoring of Product Attributes of Ribbed Roller Compacted Flakes , 2013, AAPS PharmSciTech.

[4]  E. S. Ghaly,et al.  Prediction of Tablet Hardness and Porosity Using Near‐Infrared Diffuse Reflectance Spectroscopy as a Nondestructive Method , 2003, Pharmaceutical development and technology.

[5]  Don Clark,et al.  Chemical images: Technical approaches and issues , 2006, Cytometry. Part A : the journal of the International Society for Analytical Cytology.

[6]  G. McCabe,et al.  Effects of changes in roller compactor parameters on granulations produced by compaction , 1992 .

[7]  Wolfgang Grellmann,et al.  How do roll compaction/dry granulation affect the tableting behaviour of inorganic materials? Microhardness of ribbons and mercury porosimetry measurements of tablets. , 2004, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[8]  Y. Ozaki,et al.  A Study on Water Adsorption onto Microcrystalline Cellulose by Near-Infrared Spectroscopy with Two-Dimensional Correlation Spectroscopy and Principal Component Analysis , 2006, Applied spectroscopy.

[9]  P. Kleinebudde,et al.  How do roll compaction/dry granulation affect the tableting behaviour of inorganic materials? Comparison of four magnesium carbonates. , 2003, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[10]  J. Remon,et al.  Roller compaction and tableting of microcrystalline cellulose/drug mixtures , 1998 .

[11]  M. Blanco,et al.  Content uniformity studies in tablets by NIR-CI. , 2011, Journal of pharmaceutical and biomedical analysis.

[12]  Ariel R. Muliadi,et al.  Evaluation of Three Approaches for Real-Time Monitoring of Roller Compaction with Near-Infrared Spectroscopy , 2012, AAPS PharmSciTech.

[13]  J. Rantanen,et al.  Near-infrared imaging for high-throughput screening of moisture induced changes in freeze-dried formulations. , 2014, Journal of pharmaceutical sciences.

[14]  A near-infrared spectroscopic investigation of relative density and crushing strength in four-component compacts. , 2009, Journal of pharmaceutical sciences.

[15]  Jean Paul Remon,et al.  Visualization and understanding of the granulation liquid mixing and distribution during continuous twin screw granulation using NIR chemical imaging. , 2014, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[16]  Slobodan Sasić,et al.  An In-Depth Analysis of Raman and Near-Infrared Chemical Images of Common Pharmaceutical Tablets , 2007, Applied spectroscopy.

[17]  K. Morris,et al.  Real-time near-infrared monitoring of content uniformity, moisture content, compact density, tensile strength, and Young's modulus of roller compacted powder blends. , 2005, Journal of pharmaceutical sciences.

[18]  José Manuel Amigo,et al.  Study of pharmaceutical samples by NIR chemical-image and multivariate analysis , 2008 .

[19]  J. Rantanen,et al.  Use of in-line near-infrared spectroscopy in combination with chemometrics for improved understanding of pharmaceutical processes. , 2005, Analytical chemistry.

[20]  S. Wold,et al.  Principal component analysis of multivariate images , 1989 .

[21]  R. Bro Multivariate calibration: What is in chemometrics for the analytical chemist? , 2003 .

[22]  James K. Drennen,et al.  Near-Infrared Spectroscopy: Applications in the Analysis of Tablets and Solid Pharmaceutical Dosage Forms , 1995 .

[23]  Lianghao Han,et al.  Hardness and density distributions of pharmaceutical tablets measured by terahertz pulsed imaging. , 2013, Journal of pharmaceutical sciences.

[24]  P. Guigon,et al.  Roll press design—influence of force feed systems on compaction , 2003 .

[25]  José Manuel Amigo,et al.  Direct quantification and distribution assessment of major and minor components in pharmaceutical tablets by NIR-chemical imaging. , 2009, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[26]  Ronald W Miller,et al.  Roller Compaction Technology for the Pharmaceutical Industry , 2013 .

[27]  Vivek S. Dave,et al.  Assessment of the critical factors affecting the porosity of roller compacted ribbons and the feasibility of using NIR chemical imaging to evaluate the porosity distribution. , 2011, International journal of pharmaceutics.