Prediction of dissolution profiles by non-destructive NIR spectroscopy in bilayer tablets

Yukteshwar Baranwal, Andrés D. Román-Ospino, Golshid Keyvan, Jung Myung Ha, Eon Pyo Hong, Fernando J. Muzzio, Rohit Ramachandran

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

Abstract

This study describes how near infrared (NIR) spectroscopy can be used to predict the dissolution of bilayer tablets as a non-destructive approach. Tablets in this study consist of two active pharmaceutical ingredients (APIs) physically separated in layers and manufactured under three levels of hardness. NIR spectra were individually acquired for both layers in diffuse reflectance mode. Reference dissolution profile values were obtained using dissolution apparatus & HPLC. A multivariate partial least squares (PLS) calibration model was developed for each API relating its dissolution profile to spectral data. This calibration model was used to predict dissolution profiles of an independent test set and results of the prediction were compared using model free approaches i.e. dissimilarity (f1) & similarity (f2) factors to assure similarity in dissolution performance.

Original languageEnglish (US)
Pages (from-to)419-436
Number of pages18
JournalInternational Journal of Pharmaceutics
Volume565
DOIs
StatePublished - Jun 30 2019

All Science Journal Classification (ASJC) codes

  • Pharmaceutical Science

Keywords

  • Bilayer tablets
  • HPLC
  • NIR
  • PCA
  • PLS
  • RTRT

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