Skip to main content

Advertisement

SpringerLink
Log in

Application of a newly developed portable NIR imaging device to monitor the dissolution process of tablets

  • Research Paper
  • Published:
Analytical and Bioanalytical Chemistry Aims and scope Submit manuscript

Abstract

We have recently developed a novel portable NIR imaging device (D-NIRs), which has a high speed and high wavelength resolution. This NIR imaging approach has been developed by utilizing D-NIRs for studying the dissolution of a model tablet containing 20 % ascorbic acid (AsA) as an active pharmaceutical ingredient and 80 % hydroxypropyl methylcellulose, where the tablet is sealed by a special cell. Diffuse reflectance NIR spectra in the 1,000 to 1,600 nm region were measured during the dissolution of the tablet. A unique band at around 1,361 nm of AsA was identified by the second derivative spectra of tablet and used for AsA distribution NIR imaging. Two-dimensional change of AsA concentration of the tablet due to water penetration is clearly shown by using the band-based image at 1,361 nm in NIR spectra obtained with high speed. Moreover, it is significantly enhanced by using the intensity ratio of two bands at 1,361 and 1,354 nm corresponding to AsA and water absorption, respectively, showing the dissolution process. The imaging results suggest that the amount of AsA in the imaged area decreases with increasing water penetration. The proposed NIR imaging approach using the intensity of a specific band or the ratio of two bands combined with the developed portable NIR imaging instrument, is a potentially useful practical way to evaluate the tablet at every moment during dissolution and to monitor the concentration distribution of each drug component in the tablet.

Visible photo and NIR image for tablet dissolution obtained by using a newly developed portable NIR imaging device: D-NIRs

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6
Fig. 7
Fig. 8
Fig. 9

Similar content being viewed by others

References

  1. Bakeev KA (2005) Process analytical technology—spectroscopic tools and implementation strategies for the chemical and pharmaceutical industries. Blackwell, London

    Book  Google Scholar 

  2. Hinz CD (2006) Process analytical technologies in the pharmaceutical industry the FDA's PAT initiative. Anal Bioanal Chem 384:1036–1042

    Article  CAS  Google Scholar 

  3. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (2009) ICH Harmonised Tripartite Guideline Pharmaceutical Development Q8 (R2)

  4. Rathore SA, Bhambure R, Ghare V (2010) Process analytical technology (PAT) for biopharmaceutical products. Anal Bioanal Chem 398:137–154

    Article  CAS  Google Scholar 

  5. Ozaki Y (2012) Near-infrared spectroscopy—its versatility in analytical chemistry. Anal Sci 28:545–562

    Article  CAS  Google Scholar 

  6. Trafford AD, Jee RD, Moffat AC, Graham P (1999) A rapid quantitative assay of intact paracetamol tablets by reflectance near-infrared spectroscopy. Analyst 124:163–167

    Article  CAS  Google Scholar 

  7. Andersson M, Folestad S, Gottfries J, Johansson MO, Josefson M, Wahlund KG (2000) Quantitative analysis of film coating in a fluidized bed process by in-line NIR spectrometry and multivariate batch calibration. Anal Chem 2099–2108

  8. Rantanen J, Räsänen E, Tenhunen J, Lansakosli M, Mannermaa JP, Yliruusi J (2000) In-line moisture measurement during granulation with a four-wavelength near infrared sensor: an evaluation of particle size and binder effect. Eur J Pharm Biopharm 50:271–276

    Article  CAS  Google Scholar 

  9. Ufret C, Morris K (2001) Modeling of powder blending using on-line near infrared measurements. Drug Dev Ind Pharm 27:719–729

    Article  CAS  Google Scholar 

  10. Li W, Worosila GD, Wang W, Mascaro T (2005) Determination of polymorphconversion of an active pharmaceutical ingredient in wet granulation using NIR calibration models generated from the premix blends. J Pharm Sci 94:2800–2806

    Article  CAS  Google Scholar 

  11. Roggo Y, Chalus P, Manurer L, Martinez CL, Edmond A, Jent N (2007) A review of near infrared spectroscopy and chemometrics in pharmaceutical technology. J Pharm Biomed Anal 44(3):683–700

    Article  CAS  Google Scholar 

  12. Kogermann K, Aaltonen J, Strachan CJ, Pollanen K, Heinamaki J, Yliruusi J, Rantanen J (2008) Establishing quantitative in-line analysis of multiple solid-state transformations during dehydration. J Pharm Sci 97:4983–4999

    Article  CAS  Google Scholar 

  13. Siesler HW, Ozaki Y, Kawata S, Heise HM (2002) Near-infrared spectroscopy. Wiley, Weinheim

    Google Scholar 

  14. Ozaki Y, Morita S (2009) Encyclopedia of applied spectroscopy. Wiley, Weinheim

    Google Scholar 

  15. Komiyama M, Sanpei Y, Miura A, Sakakibara K, Yakihara T, Fujita T, Kobayashi S, Oka S, Akasaka Y (2003) US Patent 6,552,325 B1

  16. Murayama K, Genkawa T, Ishikawa D, Komiyama M, Ozaki Y (2013) A polychromator-type near-infrared spectrometer with a high-sensitivity and high-resolution photodiode array detector for pharmaceutical process monitoring on the millisecond time scale. Rev Sci Instrum 84:023104

    Article  Google Scholar 

  17. Bettini R, Catellani PL, Santi P, Massimo G, Peppas PN, Colombo P (2001) Translocation of drug particles in HPMC matrix gel layer: effect of drug solubility and influence on release rate. J Control Release 70:383–391

    Article  CAS  Google Scholar 

  18. Gao P, Meury RH (1996) Swelling of hydroxypropyl methylcellulosematrix tablets. 1. Characterization of swelling using a novel optical imaging method. J Pharm Sci 85:725–731

    Article  CAS  Google Scholar 

  19. Kimber JA, Kazarian SG, Štěpánek F (2013) Formulation design space analysis for drug release from swelling polymer tablets. Powder Technol 236:179–187

    Article  CAS  Google Scholar 

  20. Van der Weerd J, Kazarian SG (2004) Combined approach of FTIR imaging and conventional dissolution tests applied to drug release. J Control Release 98:295–305

    Article  Google Scholar 

  21. Kazarian SG, Van der Weerd J (2008) Simultaneous FTIR spectroscopic imaging and visible photography to monitor tablet dissolution and drug release. Pharm Res 25(4):853–860

    Article  CAS  Google Scholar 

  22. Hattori Y, Otsuka M (2011) NIR spectroscopic study of the dissolution process in pharmaceutical tablets. Vib Spectrosc 57(2):275–281

    Google Scholar 

  23. Morita S, Shinzawa H, Noda I, Ozaki Y (2006) Perturbation-correlation moving-window two-dimensional correlation spectroscopy. Appl Spectrosc 60:398–406

    Article  CAS  Google Scholar 

  24. Šašić S, Ozaki Y (2009) Raman, infrared, and near-infrared chemical imaging. Wiley, New York

    Google Scholar 

  25. Lewis NE, Schoppelrei J, Lee E (2004) Near-infrared chemical imaging and the PAT initiative—NIR-CI adds a completely new dimension to conventional NIR spectroscopy. Spectroscopy 19(4):28–34

    Google Scholar 

  26. EL-Hagrasy AS, Morris HR, D’amico F, Lodder RA, Dernnen JK III (2001) Near-infrared spectroscopy and imaging for the monitoring of powder blend homogeneity. J Pharm Sci 90(9):1298–1307

    Article  CAS  Google Scholar 

  27. Amigo JM, Ravn C (2009) Direct quantification and distribution assessment of major and minor component in pharmaceutical tablets by NIR-chemical imaging. Eur J Pharm Sci 37(2):76–82

    Article  CAS  Google Scholar 

  28. Lewis EN, Carroll JE, Clarke FM (2001) A near-infrared view of pharmaceutical formulation analysis. NIR News 12(3):16–18

    Article  Google Scholar 

  29. Awa K, Okumura T, Shinzawa H, Otsuka M, Ozaki Y (2008) Self-modeling curve resolution (SMCR) analysis of near-infrared (NIR) imaging data of pharmaceutical tablets. Anal Chim Acta 619:81–86

    Article  CAS  Google Scholar 

  30. Ishikawa D, Murayama K, Genkawa T, Awa K, Komiyama M, Ozaki Y (2012) Development of compact near infrared imaging device with high-speed and portability for pharmaceutical process monitoring. NIR News 23(8):14–17

    Article  Google Scholar 

  31. Griffiths PR, Olinger MJ (2002) In: Chalmers JM, Griffiths PR (eds) Handbook of vibrational spectroscopy, vol 1. Wiley, New York

    Google Scholar 

  32. Savitzky A, Golay MJE (1964) Smoothing and differentiation of data by simplified least squares procedures. Anal Chem 36(8):1627–1639

    Article  CAS  Google Scholar 

  33. Kasemsumran Y, Du P, Murayama K, Huehne M, Ozaki Y (2004) Near-infrared spectroscopic determination of human serum albumin, γ-globulin, and glucose in a control serum solution with searching combination moving window partial least squares. Anal Chim Acta 512:223–230

    Article  CAS  Google Scholar 

  34. Sahoo S, Kanti C, Mishra CS, Naik S (2011) Analytical characterization of a gelling biodegradable polymer. Drug Invention Today 3(6):78–82

    CAS  Google Scholar 

  35. Pérez-Ramos DJ, Findlay PW, Peck G, Morris RK (2005) Quantitative analysis of film coating in a pan coater based on in-line sensor measurements. AAPS Pharma Sci Tech 6(1):127–136

    Article  Google Scholar 

  36. Lui H, Xiang BR, Qu LB (2006) Structure analysis of ascorbic acid using near-infrared spectroscopy and generalized two-dimensional correlation spectroscopy. Molecular Structure 794:12–17

    Article  Google Scholar 

Download references

Acknowledgment

The study was supported by the “Innovation Promotion Program” of the New Energy and Industrial Technology Development Organization (NEDO), Ministry of Economy, Trade and Industry, Japan.

Author information

Authors and Affiliations

  1. School of Science and Technology, Kwansei Gakuin University, 2-1 Gakuen, Sanda, Hyogo, 669-1337, Japan

    Daitaro Ishikawa & Yukihiro Ozaki

  2. Yokogawa Electric Corporation, 2-9-32 Nakacho, Musashino, Tokyo, 180-8750, Japan

    Kodai Murayama & Makoto Komiyama

  3. Dainippon Sumitomo Pharma Co., Ltd, 3-1-98 Kasugade-naka, Konohana, Osaka, 554-0022, Japan

    Kimie Awa

  4. Faculty of Life and Environmental Sciences, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8572, Japan

    Takuma Genkawa

  5. Department of Chemical Engineering, Imperial College London, London, SW7 2AZ, UK

    Sergei G. Kazarian

Authors
  1. Daitaro Ishikawa
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Kodai Murayama
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Kimie Awa
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Takuma Genkawa
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Makoto Komiyama
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Sergei G. Kazarian
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Yukihiro Ozaki
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Yukihiro Ozaki.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Ishikawa, D., Murayama, K., Awa, K. et al. Application of a newly developed portable NIR imaging device to monitor the dissolution process of tablets. Anal Bioanal Chem 405, 9401–9409 (2013). https://doi.org/10.1007/s00216-013-7355-6

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00216-013-7355-6

Keywords

Search

Navigation