Prediction of dissolution time and coating thickness of sustained release formulations using Raman spectroscopy and terahertz pulsed imaging.

Raman spectroscopy was implemented successfully as a non-invasive and rapid process analytical technology (PAT) tool for in-line quantitative monitoring of functional coating. Coating experiments were performed at which diprophylline tablets were coated with a sustained release formulation based on Kollicoat SR 30 D. Using PLS a multivariate model was constructed by correlating Raman spectral data with the mean dissolution time as determined by dissolution testing and the coating thickness as measured by terahertz pulsed imaging. By performing in-line measurements it was possible to monitor the progress of the coating process and to detect the end point of the process, where the acquired coating amount was achieved for the desired MDT or coating thickness.

[1]  M Pepper,et al.  Analysis of sustained-release tablet film coats using terahertz pulsed imaging. , 2007, Journal of controlled release : official journal of the Controlled Release Society.

[2]  B. Buchanan,et al.  Use of Near-Infrared Spectroscopy to Evaluate an Active in a Film Coated Tablet , 1996, Pharmaceutical Research.

[3]  M. Kemper,et al.  Direct, non-destructive quantitative measurement of an active pharmaceutical ingredient in an intact capsule formulation using Raman spectroscopy. , 2007, Analytica chimica acta.

[4]  Edward R Grant,et al.  Raman spectroscopic measurement of tablet-to-tablet coating variability. , 2005, Journal of pharmaceutical and biomedical analysis.

[5]  James K Drennen,et al.  A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending: Part II: Qualitative near-infrared models for prediction of blend homogeneity. , 2006, Journal of pharmaceutical sciences.

[6]  T. De Beer,et al.  In-line monitoring of a pharmaceutical blending process using FT-Raman spectroscopy. , 2004, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[7]  J. Drennen,et al.  Determination of film-coated tablet parameters by near-infrared spectroscopy. , 1995, Journal of pharmaceutical and biomedical analysis.

[8]  Yaochun Shen,et al.  Analysis of coating structures and interfaces in solid oral dosage forms by three dimensional terahertz pulsed imaging. , 2007, Journal of pharmaceutical sciences.

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

[10]  Y. Heyden,et al.  Raman spectroscopy as a process analytical technology (PAT) tool for the in-line monitoring and understanding of a powder blending process. , 2008, Journal of pharmaceutical and biomedical analysis.

[11]  Peter Kleinebudde,et al.  Feasibility of Raman spectroscopy as PAT tool in active coating , 2009, Drug development and industrial pharmacy.

[12]  J. Drennen,et al.  A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending. Part III: Quantitative near-infrared calibration for prediction of blend homogeneity and characterization of powder mixing kinetics. , 2006, Journal of pharmaceutical sciences.

[13]  Nouna Kettaneh-Wold,et al.  Analysis of mixture data with partial least squares , 1992 .

[14]  K. Wahlund,et al.  Monitoring of a film coating process for tablets using near infrared reflectance spectrometry. , 1999, Journal of pharmaceutical and biomedical analysis.

[15]  K. Morris,et al.  Raman spectroscopy for tablet coating thickness quantification and coating characterization in the presence of strong fluorescent interference. , 2006, Journal of pharmaceutical and biomedical analysis.

[16]  T. De Beer,et al.  Raman spectroscopy as a process analytical technology tool for the understanding and the quantitative in-line monitoring of the homogenization process of a pharmaceutical suspension. , 2006, The Analyst.

[17]  San Kiang,et al.  Raman spectroscopy for the determination of coating uniformity of tablets: assessment of product quality and coating pan mixing efficiency during scale-up , 2007, Journal of Pharmaceutical Innovation.

[18]  P. Luo,et al.  Synthesis and characterization of hydroxyapatite-ciprofloxacin delivery systems by precipitation and spray drying technique , 2008, AAPS PharmSciTech.

[19]  Hoeil Chung,et al.  New reliable Raman collection system using the wide area illumination (WAI) scheme combined with the synchronous intensity correction standard for the analysis of pharmaceutical tablets. , 2006, Analytica chimica acta.

[20]  C Vervaet,et al.  In-line and real-time process monitoring of a freeze drying process using Raman and NIR spectroscopy as complementary process analytical technology (PAT) tools. , 2009, Journal of pharmaceutical sciences.

[21]  Kinam Park,et al.  Advances in pharmaceutical materials and processing , 1998 .

[22]  Mel Koch,et al.  Process analytical chemistry. , 2005, Analytical chemistry.

[23]  Mel Koch,et al.  Process analytical chemistry. , 2011, Analytical chemistry.

[24]  James K Drennen,et al.  A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending. Part I: D-optimal design for characterization of powder mixing and preliminary spectral data evaluation. , 2006, Journal of pharmaceutical sciences.

[25]  Jukka Rantanen,et al.  Process analytical applications of Raman spectroscopy , 2007, The Journal of pharmacy and pharmacology.

[26]  Zezhi J. Shao,et al.  Drug release from kollicoat SR 30D-coated nonpareil beads: Evaluation of coating level, plasticizer type, and curing condition , 2002, AAPS PharmSciTech.

[27]  L. Eriksson Multi- and megavariate data analysis , 2006 .

[28]  He Wei,et al.  Studies of chitosan/Kollicoat SR 30D film-coated tablets for colonic drug delivery. , 2009 .

[29]  Guido Dünnebier,et al.  FDA PAT Initiative – Eine Anwendersicht zu technischen Möglichkeiten und aktueller industrieller Umsetzung , 2007 .

[30]  J. Gottfries,et al.  Quantitative analysis of film coating in a fluidized bed process by in-line NIR spectrometry and multivariate batch calibration. , 2000, Analytical chemistry.

[31]  San Kiang,et al.  Evaluation of Risk and Benefit in the Implementation of Near-Infrared Spectroscopy for Monitoring of Lubricant Mixing , 2006, Pharmaceutical development and technology.

[32]  Yaochun Shen,et al.  Monitoring the film coating unit operation and predicting drug dissolution using terahertz pulsed imaging. , 2009, Journal of pharmaceutical sciences.

[33]  DETERMINATION OF FERMENTABLE SUGARS AND NITROGENOUS COMPOUNDS IN WORT BY NEAR- AND MID-INFRARED SPECTROSCOPY , 1994 .