Showing posts with label tablet hardness testing. Show all posts
Showing posts with label tablet hardness testing. Show all posts

Thursday, 23 May 2013

Non-destructive measurement of polymer coatings on pharmaceutical tablets using X-ray micro CT and terahertz pulsed imaging

Authors: Isabelle-Sophie Russe1,2, Daniela Brock1,2, Klaus Knop2, Peter Kleinebudde2, J. Axel Zeitler1=
1 Department of Chemical Engineering and Biotechnology, University of Cambridge,  Cambridge, UK
2 Institute of Pharmaceutics and Biopharmaceutics, University of Duesseldorf, Duesseldorf, Germany


Full text: http://www.skyscan.be/company/UM2013/15.pdf

Conclusion

We conclude that TPI is a robust technique, and, that due to its very simple measurement  principle, it is an ideal measurement technique to quantify the coating thickness in process control and quality monitoring applications. The method introduced in this paper will be useful to explore whether there is an influence on  the refractive index of a given coating formulation with changes in process conditions during  coating or curing. It furthermore opens the possibility, in pharmaceutical applications and  beyond, to develop metrology standards for coatings that can be used to calibrate TPI  measurements for absolute thickness.
Beyond its use as a calibration technique for TPI the XµCT method has provided some  intriguing insight into the coating properties at extremes of the tablet geometry, at the edges  of tablets where high curvature was thought to typically prevent quantitative TPI  measurements due to strong scattering. The main limitations of the XµCT technique are the  measurement, and in particular, processing time together with the high demands in  computational power and data storage as well as the limited contrast that can be resolved  between coating and core. We therefore envisage that the main impact of this technique is likely to be in research and development and to support techniques such as TPI rather than  in routine quality control or process measurements.

...Samples were measured on a TPI imaga 2000 (Teraview Ltd., Cambridge, UK), using a point spacing grid of 200 x 200 µm and a penetration depth of 1 mm in air...


Tuesday, 21 May 2013

Quantitative analysis of the layer separation risk in bilayer tablets using terahertz pulsed imaging

International Journal of Pharmaceutics, DOI: 10.1016/j.ijpharm.2013.05.010 May 2013

Authors: Masahiro Niwaa,Yasuhiro Hiraishia, Norio Iwasakia, Katsuhide Teradab
a Pharmaceutical Technology R&D Laboratories, CMC Center, Takeda Pharmaceutical Company Ltd., 2-17-85 Jusohonmachi, Yodogawa-ku, Osaka 532-8686, Japan
b Faculty of Pharmaceutical Sciences, Toho University, 2-2-1 Miyama, Funabashi, Chiba 274-8510, Japan


More details at: http://www.sciencedirect.com/science/article/pii/S0378517313004092

Highlights

  • TPI could nondestructively detect cracks between the two layers.
  • TPI could quantify adhesion integrity of bilayer tablet by interface index.
  • Interface index showed good correlation to the layer separation tendency.
  • TPI revealed the relationship between compression pressure and interface quality.

Abstract

Layer separation is a critical defect in many bilayer tablets. Despite its importance for product quality, few studies have investigated its root cause. We evaluated bilayer tablets with varying layer separation tendencies using terahertz pulsed imaging (TPI) in comparison with other analytical methods such as tensile strength measurements, friability testing, scanning electron microscopy (SEM), and X-ray computed tomography (XRCT). The layer separation risk was determined by friability testing and shown to be correlated with the final compression pressure used for bilayer tablet fabrication. TPI could nondestructively detect cracks between the component layers that lead to layer separation. The adhesion integrity of the interface was quantified by the interface index, a unique value derived from the time-domain terahertz waveform. The interface index showed good correlation to the layer separation tendency and could distinguish interface quality among seven batches of bilayer tablets. In contrast, SEM and XRCT detected structural defects but could not distinguish batches with high or low layer separation risk. TPI revealed the relationship between compression pressure and interface quality. Thus, TPI can aid in quality control by providing a precise estimate of the layer separation risk and robust quality of bilayer tablet development with better understanding of layer separation.

... 2.5. TPI. The TPI Imaga 2000 system (TeraView Ltd., Cambridge, UK) was used in this study. ... All data were acquired using the TPI Coating Scan software version 1.7.3 (TeraView) and analyzed using TPIcsView software version 2.3.4 (TeraView). 2.6. Statistical analysis. ... 

Friday, 26 April 2013

Hardness and density distributions of pharmaceutical tablets measured by terahertz pulsed imaging

Journal of Pharmaceutical Sciences
22 Apr 2013; +Wiley Textbooks
DOI: 10.1002/jps.23560

Authors: Robert K. May1,4, Ke Su1, Lianghao Han2, Shuncong Zhong3, James A. Elliott2, Lynn F. Gladden1, Mike Evans4, Yaochun Shen3, J. Axel Zeitler1
1. Department of Chemical Engineering and Biotechnology,+Cambridge University Press Education, Cambridge CB2 3RA, UK
2. Department of Materials Science and Metallurgy, +Cambridge University Press Education, Cambridge CB2 3QZ, UK
3. Department of Electrical Engineering and Electronics, +University of Liverpool, Liverpool L69 3GJ, UK
4. +TeraView Ltd., St John’s Innovation Park, Cambridge, CB4 0WS, UK

Abstract


We present terahertz pulsed imaging (TPI) as a novel tool to quantify the hardness and surface density distribution of pharmaceutical tablets. Good agreement between the surface refractive index (SRI) measured by TPI and the crushing force measured from diametral compression tests was found using a set of tablets that were compacted at various compression forces. We also found a strong correlation between TPI results and tablet bulk density, and how these relate to tablet hardness. Numerical simulations of tablet surface density distribution by finite element analysis exhibit excellent agreement with the TPI measured SRI maps. These results show that TPI has an advantage over traditional diametral compression and is more suitable for nondestructive hardness and density distribution monitoring and control of pharmaceutical manufacturing processes. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci

...Terahertz pulsed imaging reflection measurements of sample tablets were acquired using a TPI Imaga 2000 (TeraView Ltd., Cambridge, UK). A detailed description of the measurement technique was presented earlier. The system has a useful spectral range of 60GHz to 3 THz, corresponding to a wavelength range of 0.09–5mm...


More details at: http://onlinelibrary.wiley.com/doi/10.1002/jps.23560/abstract