166
Views
2
CrossRef citations to date
0
Altmetric
Research Article

Multivariate approaches for the development of quality control in-situ fiber optics dissolution methods for fixed-dose combination tablets

, &
Pages 999-1008 | Received 14 Aug 2018, Accepted 28 Feb 2019, Published online: 25 Mar 2019

References

  • Guidance for Industry: Immediate Release Solid Oral Dosage Forms. US Department of Health and Human Services, FDA CDER, 1997. Available from: https://www.fda.gov/downloads/drugs/guidances/ucm070636.pdf [Accessed 2019 Mar 17].
  • Gao Z, Moore TW, Smith AP, et al. Studies of variability in dissolution testing with USP apparatus 2. J Pharm Sci. 2007;96:1794–1801.
  • Hanson R, Gray V. Handbook of dissolution testing. Hockessin (DE): Dissolution Technologies INCO; 2004
  • Josefson M, Johansson E, Torstensson A. Optical fiber spectrometry in turbid solutions by multivariate calibration applied to tablet dissolution testing. Anal Chem. 1988;60:2666–2671.
  • Cho JH, Gemperline PJ, Salt A, et al. UV/visible spectral dissolution monitoring by in situ fiber-optic probes. Anal Chem. 1995;67:2858–2863.
  • Liu L, Fitzgerald G, Embry M, et al. Technical evaluation of a fiber-optic probe dissolution system. Dissolution Technol. 2008;15:10–20.
  • Lu X, Lozano R, Shah P. In-situ dissolution testing using different UV fiber optic probes and instruments. Dissolution Technol. 2003;10:6–15.
  • Mirza T, Liu QJ, Vivilecchia R, et al. Comprehensive validation scheme for in situ fiber optics dissolution method for pharmaceutical drug product testing. J Pharm Sci. 2009;98:1086–1094.
  • Nie K, Li L, Li X, et al. Monitoring ambroxol hydrochloride sustained-release tablets release by fiber-optic drug dissolution in situ test system. Dissolution Technol. 2009;16:14–17.
  • Toher CJ, Nielsen PE, Foreman AS, et al. In situ fiber optic dissolution monitoring of a vitamin B12 solid dosage formulation. Dissolution Technol. 2003;10:20–25.
  • Schatz C, Ulmschneider M, Altermatt R, et al. Manual in situ fiber optic dissolution analysis in quality control. Dissolution Technol. 2000;7:6–12.
  • Nie K, Li L, Li X, et al. In situ fiber-optic dissolution assisted by a mathematical separation model of dynamic three-wavelength K-ratio spectrophotometry. Dissolution Technol. 2010;17:15–18.
  • Wiberg KH, Hultin UK. Multivariate chemometric approach to fiber optic dissolution testing. Anal Chem. 2006;78:5076–5085.
  • Liu X, Liu S, Wu J, Fang Z. Simultaneous monitoring of aspirin, phenacetin and caffeine in compound aspirin tablets using a sequential injection drug-dissolution testing system with partial least squares calibration. Anal Chim Acta. 1999;392:273–281.
  • Johansson J, Cauchi M, Sundgren M. Multiple fiber-optic dual-beam UV/Vis system with application to dissolution testing. J Pharm Biomed Anal. 2002;29:469–476.
  • Li W, Chen J, Xiang B, et al. Simultaneous on-line dissolution monitoring of multicomponent solid preparations containing vitamins B1, B2 and B6 by a fiber-optic system. Anal Chim Acta. 2000;408:39–47.

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.