Chun-yan XIA, Fang-fang XU, Xin ZHANG, et al. Rapid Determination of Coating Film Thickness of Tianshu Tablets by Near Infrared Spectroscopy[J]. Chinese journal of experimental traditional medical formulae, 2020, 26(1): 118-124.
DOI:
Chun-yan XIA, Fang-fang XU, Xin ZHANG, et al. Rapid Determination of Coating Film Thickness of Tianshu Tablets by Near Infrared Spectroscopy[J]. Chinese journal of experimental traditional medical formulae, 2020, 26(1): 118-124. DOI: 10.13422/j.cnki.syfjx.20192251.
Rapid Determination of Coating Film Thickness of Tianshu Tablets by Near Infrared Spectroscopy
To investigate the feasibility of near-infrared spectroscopy for detecting the coating film thickness of Tianshu tablets.
Method:
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Nine batches of Tianshu tablets were taken during the coating process. Then
their near-infrared diffuse reflection spectra were collected. The sample set was divided into calibration set and validation set by Kennard-Stone algorithm. The preprocessing method was selected. The synergy interval partial least squares (siPLS) and moving window partial least squares (mwPLS) were employed to screen the optimal spectral interval. And the corresponding quantitative calibration model of partial least squares (PLS) were established. Some evaluation parameters were adopted to assess the performance of the model.
Result:
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The method of first derivative and Norris Derivative smoothing combined with standard normal variate transformation was suitable for processing the spectra. The optimal PLS model was established in the preferred band interval of siPLS. The correlation coefficient between the predicted value and the measured value of calibration set was 0.966
and the correlation coefficient between the predicted value and the measured value of validation set was 0.991.Both root mean square error of calibration (RMSEC) and root mean square error of prediction (RMSEP) values were small
which showed the fitness and predictive performance of the model were favorable.
Conclusion:
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The near-infrared spectroscopy technique can be used to determine coating film thickness of Tianshu tablets with high accuracy
which provides technical supports for the in-line determination of coating thickness in the production process of traditional Chinese medicine tablets.
C Cahyadi , A D Karande , L W CHAN , et al . Comparative study of non-destructive methods to quantify thickness of tablet coatings [J]. Int J Pharm , 2010 , 398 ( 1/2 ): 39 - 49 .
J D Pérez-Ramos , W P Findlay , G Peck , et al . Quantitative analysis of film coating in a pan coater based on in-line sensor measurements [J]. AAPS PharmSciTech , 2005 , 6 ( 1 ): E127 - E136 .
H LIN , Y DONG , D Markl , et al . Measurement of the inter-tablet coating uniformity of a pharmaceutical pan coating process with combined terahertz and optical coherence tomography in-line sensing [J]. J Pharm Sci , 2017 , 106 ( 4 ): 1075 - 1084 .
B Santos-Silva , M J Colbert , M Santangelo , et al . Monitoring microsphere coating processes using PAT tools in a bench scale fluid bed [J]. Eur J Pharm Sci , 2019 , 135 : 12 - 21 .
S García-Muñoz , D S Gierer . Coating uniformity assessment for colored immediate release tablets using multivariate image analysis [J]. Int J Pharm , 2010 , 395 ( 1/2 ): 104 - 113 .
S Sacher , P Wahl , M Weißensteiner , et al . Shedding light on coatings:real-time monitoring of coating quality at industrial scale [J]. Int J Pharm , 2019 , 566 : 57 - 66 .
G Podrekar , D Kitak , A Mehle , et al . In-line film coating thickness estimation of minitablets in a fluid-bed coating equipment [J]. AAPS PharmSciTech , 2018 , 19 ( 8 ): 3440 - 3453 .
P Avalle , M J Pollitt , K Bradley , et al . Development of process analytical technology (PAT) methods for controlled release pellet coating [J]. Eur J Pharm Biopharm , 2014 , 87 ( 2 ): 244 - 251 .
G Hudovornik , K Korasa , F Vrečer . A study on the applicability of in-line measurements in the monitoring of the pellet coating process [J]. Eur J Pharm Sci , 2015 , 75 : 160 - 168 .
M J Lee , C R Park , A Young , et al . Dynamic calibration for the in-line NIR monitoring of film thickness of pharmaceutical tablets processed in a fluid-bed coater [J]. J Pharm Sci , 2010 , 99 ( 1 ): 325 - 335 .
K Korasa , F Vrečer . Overview of PAT process analysers applicable in monitoring of film coating unit operations for manufacturing of solid oral dosage forms [J]. Eur J Pharm Sci , 2018 , 111 : 278 - 292 .
J J Moes , M M Ruijken , E Gout , et al . Application of process analytical technology in tablet process using NIR spectroscopy:Blend uniformity,content uniformity and coating thickness measurements [J]. Int J Pharm , 2008 , 357 ( 1/2 ): 108 - 118 .
M Andersson , M Josefson , F W Langkilde , et al . Monitoring of a film coating process for tablets using near infrared reflectance spectrometry [J]. J Pharm Biomed Anal , 1999 , 20 ( 1/2 ): 27 - 37 .
W LI , Z CHENG , Y WANG , et al . Quality control of Lonicerae Japonicae Flos using near infrared spectroscopy and chemometrics [J]. J Pharm Biomed Anal , 2013 , 72 : 33 - 39 .
H CHEN , T PAN , J CHEN , et al . Waveband selection for NIR spectroscopy analysis of soil organic matter based on SG smoothing and MWPLS methods [J]. Chemometr Intell Lab Syst , 2011 , 107 ( 1 ): 139 - 146 .
R K Galvão , M C Araujo , G E José , et al . A method for calibration and validation subset partitioning [J]. Talanta , 2005 , 67 ( 4 ): 736 - 740 .
C Gendre , M Genty , M Boiret , 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 [J]. Eur J Pharm Sci , 2011 , 43 ( 4 ): 244 - 250 .
C V Möltgen , T Puchert , J C Menezes , et al . A novel in-line NIR spectroscopy application for the monitoring of tablet film coating in an industrial scale process [J]. Talanta , 2012 , 92 : 26 - 37 .
F Westad , A Schmidt , M Kermit . Incorporating chemical band-assignment in near infrared spectroscopy regression models [J]. J Near Infrared Spec , 2008 , 16 ( 3 ): 265 - 273 .