Cited by 53Spectroscopy and Chemometric AnalysesAnalytical Methods in PharmaceuticalsPharmaceutical Quality and Counterfeiting

Application of a handheld NIR spectrometer in prediction of drug content in inkjet printed orodispersible formulations containing prednisolone and levothyroxine

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Vakili, Hossein, Wickström, Henrika, Desai, Diti, Preis, Maren, Sandler, Niklas·2017·International Journal of Pharmaceutics

Abstract

Quality control tools to assess the quality of printable orodispersible formulations are yet to be defined. Four different orodispersible dosage forms containing two poorly soluble drugs, levothyroxine and prednisolone, were produced on two different edible substrates by piezoelectric inkjet printing. Square shaped units of 4cm 2 were printed in different resolutions to achieve an escalating drug dose by highly accurate and uniform displacement of droplets in picoliter range from the printhead onto the substrates. In addition, the stability of drug inks in a course of 24h as well as the mechanical properties and disintegration behavior of the printed units were examined. A compact handheld near-infrared (NIR) spectral device in the range of 1550-1950nm was used for quantitative estimation of the drug amount in printed formulations. The spectral data was treated with mean centering, Savitzky-Golay filtering and a third derivative approach. Principal component analysis (PCA) and orthogonal partial least squares (OPLS) regression were applied to build predictive models for quality control of the printed dosage forms. The accurate tuning of the dose in each formulation was confirmed by UV spectrophotometry for prednisolone (0.43-1.95mg with R 2=0.999) and high performance liquid chromatography for levothyroxine (0.15-0.86mg with R 2=0.997). It was verified that the models were capable of clustering and predicting the drug dose in the formulations with both Q 2 and R 2 Y values between 0.94-0.99.

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Crossref · 10.1016/j.ijpharm.2017.04.014

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Authors
Vakili, H., Wickström, H., Desai, D., Preis, M., & Sandler, N.
Affiliations
Åbo Akademi University (FI)
Corresponding author
Vakili, Hossein
Venue
International Journal of Pharmaceutics
Publisher
Elsevier BV
Published
2017-05
Volume
524
Issue
1-2
Pages
414-423
ISSN
0378-5173 (ISSN-L)
OpenAlex
W2605106277
Cited by
53
References
21
Citations by year
2026: 2 · 2025: 4 · 2024: 1 · 2023: 8 · 2022: 6 · 2021: 2 · 2020: 12 · 2019: 9 · 2018: 9
FWCI
5.74
Type
journal article
Language
en
Open access
Locations
  • International Journal of Pharmaceutics (publishedVersion)
  • PubMed (publishedVersion)
  • Åbo Akademi University Research Portal (submittedVersion, cc-by-nc-nd)
Funders
Doctoral Education Network in Material Research (DNMR)
Topics
  • Physical Sciences › Chemistry › Analytical Chemistry › Spectroscopy and Chemometric Analyses
  • Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pharmaceutical Quality and Counterfeiting
Keywords
inkjet printing, prednisolone, levothyroxine, quality control, poorly water-soluble drugs, principal component analysis, dose homogeneity
MeSH terms
Administration, Oral, Chemistry, Pharmaceutical, Ink, Prednisolone, Printing, Quality Control, Thyroxine, Spectroscopy, Near-Infrared

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