Bpc2009presentation Sulaf

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Bpc2009presentation Sulaf

  1. 1. Identification of Tablets Through their Blister Packaging by Near-infrared Spectroscopy S. Assi. R. A. Watt and A.C. Moffat The School of Pharmacy 29/39 Brunswick Square, London. [email_address]
  2. 2. Objective <ul><li>To identify tablets in blister packaging. </li></ul>
  3. 3. Types of blister packaging <ul><li>The blister packaging consists of the front and backing foil. The front foil is being inspected here. </li></ul>ColourlessTransparent (CT) (PVC or PVDC) White Opaque (WO) (PVC or PVDC) Aluminium Foil (AF) (aluminium)
  4. 4. Experimental <ul><li>A total of 20 different products in CT blisters were used. </li></ul><ul><li>The spectra were measured using a FOSS 6500 NIR spectrometer equipped with a Smart Probe. </li></ul><ul><li>Spectra were processed using SNV-D2 excluding the regions 1666-1796 and 2200-2500 nm and correlation in wavelength space method (CWS) and principal component analysis (PCA) were used. </li></ul>
  5. 5. Results (1): Background Selection <ul><li>Top left: The Smart Probe measuring the tablet in blister on top of a Spectralon 20% reflectance standard. </li></ul><ul><li>Top right: SNV-D2 NIR spectra of Ciproxin tablet alone and in its blister with ceramic reference as a background. </li></ul><ul><li>Bottom right: SNV-D2 NIR spectra of Ciproxin tablet alone and in its blister with a reference scan as a blister on top of a Spectralon 20% reference as a background. </li></ul>r 2 =0.94 r 2 =0.98
  6. 6. Results (2): Change of correlation coefficients using different Spectralon reflectance standards 2 to 99 %.
  7. 7. Results(3): Inter-blister packaging variation <ul><li>Upper right: The position of the tablet was changed inside the blister packaging to see the effect of changing position. </li></ul>Lower right: The value of the correlation coefficient against the same Ciproxin tablet put in different positions of the blister packaging .
  8. 8. Results (4): Intra-batch and Inter-batch variation <ul><li>Intra-batch: </li></ul><ul><li>10 tablets of the same batch. </li></ul><ul><li>r 2 (minimum)=0.98. </li></ul>Inter-batch: 8 batches of the same product. r 2 (minimum)=0.94.
  9. 9. Results (5): Discrimination of products <ul><li>Upper right: SNV-D2 NIR spectra of the 20 products measured. </li></ul>Lower left: Correlation map of the 20 products measured. Wrongly matching products: Lipitor, Risperidal,Singulair and Zyprexa.
  10. 10. Results (6) List of excipients in the four wrongly matching products.
  11. 11. <ul><li>PCA score plot of the SNV-D2 NIR spectra of the 4 wrongly matching products. </li></ul>Results (7): Discrimination of products
  12. 12. Conclusion <ul><li>The use of an NIRS FOSS 6500 probe using a reference of a closed CT blister packaging on top of a 20 % NIST standard could identify tablets inside CT blisters and discriminate them from substitutes. </li></ul><ul><li>The method could identify the 20 products examined by combination of CWS with a threshold of 0.94 and PCA. </li></ul>
  13. 13. Acknowledgement <ul><li>FOSS NIRSystem for the FOSS 6500 instrument. </li></ul><ul><li>The School of Pharmacy for the Overseas Student Research (ORS) Award. </li></ul><ul><li>Lebanese National Council for Scientific Research for their Scholarship. </li></ul>

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