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

·         European Journal of Pharmaceutics and Biopharmaceutics

Available online 5 January 2012

• Joshua Müller^a, 
• Daniela Brock^a, 
• Klaus Knop^a, 
• J. Axel Zeitler^b, 
• Peter Kleinebudde

• Abstract

  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.
  
  Mean dissolution time (MDT) over coating time predicted by Raman spectroscopy (top left) and in correlation to coating thickness measured by terahertz spectroscopy (top right). Layer thickness maps and histograms from TPI measurements after a short (left) and a longer (right) coating time.
  
  
  Terahertz results were acquired on a TeraView's TPI2000 instrument.
  
  
  For more information :
  http://www.sciencedirect.com/science/article/pii/S0939641111003614
  
  

  Keywords

  • Process analytical technology; 
  • Multivariate data analysis; 
  • Raman spectroscopy; 
  • Terahertz pulsed imaging; 
  • Functional coating; 
  • Mean dissolution time