102
Views
2
CrossRef citations to date
0
Altmetric
Research Articles

Optimization of in-line near-infrared measurement for practical real time monitoring of coating weight gain using design of experiments

&
Pages 72-82 | Received 02 Apr 2020, Accepted 07 Dec 2020, Published online: 16 Dec 2020

References

  • Siepmann J , Siepmann F. Stability of aqueous polymeric controlled release film coatings. Int J Pharm. 2013;457(2):437–445.
  • Pandey P , Bindra DS , Felton LA. Influence of process parameters on tablet bed microenvironmental factors during pan coating. AAPS PharmSciTech. 2014;15(2):296–305.
  • Hisazumi J , Kleinebudde P. In-line monitoring of multi-layered film-coating on pellets using Raman spectroscopy by MCR and PLS analyses. Eur J Pharm Biopharm. 2017;114:194–201.
  • Lin H , Dong Y , Markl D , et al. Measurement of the intertablet coating uniformity of a pharmaceutical pan coating process with combined terahertz and optical coherence tomography in-line sensing. J Pharm Sci. 2017;106(4):1075–1084.
  • Gendre C , Genty M , Boiret M , et al. Development of a Process Analytical Technology (PAT) for in-line monitoring of film thickness and mass of coating materials during a pan coating operation. Eur J Pharm Sci. 2011;43(4):244–250.
  • Knop K , Kleinebudde P. PAT-tools for process control in pharmaceutical film coating applications. Int J Pharm. 2013;457(2):527–536.
  • Woo YA , Kim JY , Park YJ , et al. Process Analytical Technology (PAT): field applications and current status in pharmaceutical industries. Anal Sci Technol. 2009;22(1):35–43.
  • Cho S , Chung H , Woo YA , et al. Determination of water content in ethanol by miniaturized near-infrared (NIR) system. Bull Korean Chem Soc. 2005;26(1):115–119.
  • Woo YA , Lim HR , Kim HJ , et al. Determination of hydrogen peroxide concentration in antiseptic solutions using portable near-infrared system. J Pharm Biomed Anal. 2003;33(5):1049–1057.
  • Petit S , Martin F , Wiewiora A , et al. Crystal-chemistry of talc: a near infrared (NIR) spectroscopy study. Am Mineral. 2004;89(2–3):319–326.
  • Kim DW , Park JB , Lee SH , et al. Development of a Process Analytical Technology (PAT) method using near-infrared spectroscopy system for evaluating an active coating process for a low-dose drug. J Drug Deliv Sci Technol. 2017;39:8–15.
  • Bikiaris D , Koutri I , Alexiadis D , et al. Real time and non-destructive analysis of tablet coating thickness using acoustic microscopy and infrared diffuse reflectance spectroscopy. Int J Pharm. 2012;438(1–2):33–44.
  • Kirsch JD , Drennen JK. Near-infrared spectroscopic monitoring of the film coating process. Pharm Res. 1996;13(2):234–237.
  • Pérez-Ramos JD , Findlay WP , Peck G , et al. Quantitative analysis of film coating in a pan coater based on in-line sensor measurements. AAPS PharmSciTech. 2005;6(1):E127–136.
  • Gendre C , Boiret M , Genty M , et al. Real-time predictions of drug release and end point detection of a coating operation by in-line near infrared measurements. Int J Pharm. 2011;421(2):237–243.
  • Hattori Y , Sugata M , Kamata J , et al. Real-time monitoring of the tablet-coating process by near-infrared spectroscopy – effects of coating polymer concentrations on pharmaceutical properties of tablets. J Drug Deliv Sci Technol. 2018;46:111–121.
  • Möltgen CV , Puchert T , Menezes JC , et al. A novel in-line NIR spectroscopy application for the monitoring of tablet film coating in an industrial scale process. Talanta. 2012;92:26–37.
  • Kim B , Woo YA. Coating process optimization through in-line monitoring for coating weight gain using Raman spectroscopy and design of experiments. J Pharm Biomed Anal. 2018;154:278–284.
  • DiFoggio R. Examination of some misconceptions about near-infrared analysis. Appl Spectrosc. 1995;49(1):67–75.
  • van der Voet H. Comparing the predictive accuracy of models using a simple randomization test. Chemom Intell Lab Syst. 1994;25(2):313–323.
  • Sondej F , Bück A , Koslowsky K , et al. Investigation of coating layer morphology by micro-computed X-ray tomography. Powder Technol. 2015;273:165–175.
  • Evaluation of measurement data – guide to the expression of uncertainty in measurement. JCGM. 2008;100:2–27.
  • Eriksson L , Johansson E , Kettaneh-Wood N , et al. Design of experiments: principles and applications. Umea (Sweden): MKS Umetrics AB; 2008. p. 149–154.
  • Ellison SLR, Williams A, editors. Quantifying the uncertainty in analytical measurement. 3rd ed. EURACHEM/CITAC (UK); 2012.
  • Toschkoff G , Just S , Knop K , et al. Modeling of an active tablet coating process. J Pharm Sci. 2015;104(12):4082–4092.
  • Kalbag A , Wassgren C. Inter-tablet coating variability: tablet residence time variability. Chem Eng Sci. 2009;64(11):2705–2717.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.