Testing the Limits of a Portable NIR Spectrometer: Content Uniformity of Complex Powder Mixtures Followed by Calibration Transfer for In-Line Blend Monitoring.

Publisher: MDPI Country of Publication: Switzerland NLM ID: 100964009 Publication Model: Electronic Cited Medium: Internet ISSN: 1420-3049 (Electronic) Linking ISSN: 14203049 NLM ISO Abbreviation: Molecules Subsets: MEDLINE

Original Publication: Basel, Switzerland : MDPI, c1995-

Chemistry, Pharmaceutical* ; Drug Compounding* ; Technology, Pharmaceutical*; Calibration ; Powders ; Spectroscopy, Near-Infrared

(1) Background: Portable NIR spectrometers gain more and more ground in the field of Process Analytical Technology due to the easy on-site flexibility and interfacing versatility. These advantages that originate from the instrument miniaturization, also come with a downside with respect to performance compared to benchtop devices. The objective of this work was to evaluate the performance of MicroNIR in a pharmaceutical powder blend application, having three active ingredients and 5 excipients. (2) Methods: Spectral data was recorded in reflectance mode using static and dynamic acquisition, on calibration set samples developed using an experimental design. (3) Results: The developed method accurately predicted the content uniformity of these complex mixtures, moreover it was validated in the entire calibration range using ±10% acceptance limits. With respect to at-line prediction, the method presented lower performance compared to a previously studied benchtop spectrometer. Regarding the in-line monitoring of the blending process, it was shown that the spectral variability-induced by dynamic acquisition could be efficiently managed using spectral pre-processing. (4) Conclusions: The in-line process monitoring resulted in accurate concentration profiles, highlighting differences in the mixing behaviour of the investigated ingredients. For the low dose component homogeneity was not reached due to an inefficient dispersive mixing.

Eur J Pharm Biopharm. 2013 Aug;84(3):606-15. (PMID: 23419815)
Int J Pharm. 2009 Oct 1;380(1-2):49-54. (PMID: 19576977)
J Pharm Biomed Anal. 2013 Oct;84:285-92. (PMID: 23347649)
Talanta. 2017 May 15;167:333-343. (PMID: 28340729)
Int J Pharm. 2021 Jan 5;592:120048. (PMID: 33161037)
Eur J Pharm Sci. 2013 Mar 12;48(4-5):680-8. (PMID: 23313622)
J Pharm Biomed Anal. 2004 Nov 15;36(3):579-86. (PMID: 15522533)
J Pharm Biomed Anal. 2013 Mar 25;76:28-35. (PMID: 23291440)
Int J Pharm. 2019 Jul 20;566:454-462. (PMID: 31170478)
Int J Pharm. 2019 Apr 5;560:322-333. (PMID: 30763679)
J Pharm Biomed Anal. 2008 Aug 5;47(4-5):738-45. (PMID: 18486399)
J Pharm Biomed Anal. 2013 Jun;80:18-23. (PMID: 23511228)
Talanta. 2018 Oct 1;188:404-416. (PMID: 30029394)
J Pharm Biomed Anal. 2016 May 10;123:120-7. (PMID: 26895497)
Int J Pharm. 2007 Aug 1;340(1-2):97-103. (PMID: 17467204)
Asian J Pharm Sci. 2020 Jul;15(4):506-517. (PMID: 32952673)
Talanta. 2021 Jan 1;221:121165. (PMID: 33076045)
Int J Pharm. 2008 Jun 5;357(1-2):108-18. (PMID: 18394831)
Eur J Pharm Biopharm. 2014 Jul;87(2):271-8. (PMID: 24705126)
Eur J Pharm Sci. 2011 Jan 18;42(1-2):106-15. (PMID: 21056102)
J Pharm Biomed Anal. 2009 Jan 15;49(1):48-54. (PMID: 19027256)
Spectrochim Acta A Mol Biomol Spectrosc. 2021 Mar 15;249:119342. (PMID: 33360568)
Int J Pharm. 2013 Jul 15;451(1-2):67-75. (PMID: 23651640)

PN-III-P2-2.1-PTE-2019-0445 Unitatea Executiva pentru Finantarea Invatamantului Superior, a Cercetarii, Dezvoltarii si Inovarii

Keywords: PAT; blending; multivariate calibration; portable NIR; validation

0 (Powders)

Date Created: 20210306 Date Completed: 20210407 Latest Revision: 20210407

20240829

PMC7924328

10.3390/molecules26041129

33672675