70
Views
0
CrossRef citations to date
0
Altmetric
Research Articles

Drug content determination of low-dosed hot-melt extruded filaments using Raman spectroscopy

, &
Pages 258-264 | Received 01 Nov 2023, Accepted 22 Feb 2024, Published online: 28 Feb 2024

References

  • Baradez MO, Biziato D, Hassan E, Marshall D. 2018. Application of Raman spectroscopy and univariate modelling as a process analytical technology for cell therapy bioprocessing. Front Med (Lausanne). 5:47. doi: 10.3389/fmed.2018.00047.
  • Barimani S, Kleinebudde P. 2017. Evaluation of in–line Raman data for end-point determination of a coating process: comparison of science–based calibration, PLS-regression and univariate data analysis. Eur J Pharm Biopharm. 119:28–35. doi: 10.1016/j.ejpb.2017.05.011.
  • Brammer E, Halbert G, Lamprou D. 2016. An investigation into drug content uniformity in fused filament fabrication. Poster presentation, AAPS Annual meeting and exposition. USA: Denver.
  • Censi R, Gigliobianco MR, Casadidio C, Di Martino P. 2018. Hot melt extrusion: highlighting physicochemical factors to be investigated while designing and optimizing a hot melt extrusion process. Pharmaceutics. 10(3):89. doi: 10.3390/pharmaceutics10030089.
  • Chamberlain R, Windolf H, Geissler S, Quodbach J, Breitkreutz J. 2022. Precise dosing of pramipexole for low-dosed filament production by hot melt extrusion applying various feeding methods. Pharmaceutics. 14(1):216. doi: 10.3390/pharmaceutics14010216.
  • Chen Q, Zhang C, Zhao J, Ouyang Q. 2013. Recent advances in emerging imaging techniques for non-destructive detection of food quality and safety. Trends Anal Chem. 52:261–274. doi: 10.1016/j.trac.2013.09.007.
  • Dadou SM, Senta-Loys Z, Almajaan A, Li S, Jones DS, Healy AM, Tian Y, Andrews GP. 2020. The development and validation of a quality by design based process analytical tool for the inline quantification of Ramipril during hot-melt extrusion. Int J Pharm. 584:119382. doi: 10.1016/j.ijpharm.2020.119382.
  • De Beer T, Burggraeve A, Fonteyne M, Saerens L, Remon JP, Vervaet C. 2011. Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes. Int J Pharm. 417(1–2):32–47. doi: 10.1016/j.ijpharm.2010.12.012.
  • Esbensen KH, Paasch-Mortensen P. 2010. Process sampling: theory of sampling–the missing link in process analytical technologies (PAT). In: Bakeev, K.A, editors. Process analytical technology. Hoboken (NJ): John Wiley & Sons; p. 37–80
  • European Pharmacopoeia. 2022. (Ph. Eur., 2.9.40, 11th edition).
  • Goyanes A, Det-Amornrat U, Wang J, Basit AW, Gaisford S. 2016. 3D scanning and 3D printing as innovative technologies for fabricating personalized topical drug delivery systems. J Control Release. 234:41–48. doi: 10.1016/j.jconrel.2016.05.034.
  • Gryczke A. 2013. Hot-melt extrusion process design using process analytical technology. Melt Extrusion: Mater Tech Drug Product Des. 9:397–431.
  • Hausman DS, Cambron RT, Sakr A. 2005. Application of Raman spectroscopy for on-line monitoring of low dose blend uniformity. Int J Pharm. 298(1):80–90. doi: 10.1016/j.ijpharm.2005.04.011.
  • Li B, Calvet A, Casamayou-Boucau Y, Morris C, Ryder AG. 2015. Low-content quantification in powders using Raman spectroscopy: a facile chemometric approach to sub 0.1% limits of detection. Anal Chem. 87(6):3419–3428. doi: 10.1021/ac504776m.
  • Lin H, Dong Y, Markl D, Williams BM, Zheng Y, Shen Y, Zeitler JA. 2017. Measurement of the intertablet coating uniformity of a pharmaceutical pan coating process with combined terahertz and optical coherence tomography in-line sensing. J Pharm Sci. 106(4):1075–1084. doi: 10.1016/j.xphs.2016.12.012.
  • Long J, Gholizadeh H, Lu J, Bunt C, Seyfoddin A. 2017. Application of fused deposition modelling (FDM) method of 3D printing in drug delivery. Curr Pharm Des. 23(3):433–439. doi: 10.2174/1381612822666161026162707.
  • Okwuosa TC, Stefaniak D, Arafat B, Isreb A, Wan KW, Alhnan MA. 2016. A lower temperature FDM 3D printing for the manufacture of patient-specific immediate release tablets. Pharm Res. 33(11):2704–2712. doi: 10.1007/s11095-016-1995-0.
  • Quodbach J, Bogdahn M, Breitkreutz J, Chamberlain R, Eggenreich K, Elia AG, Gottschalk N, Gunkel-Grabole G, Hoffmann L, Kapote D, et al. 2021. Quality of FDM 3D printed medicines for pediatrics: considerations for formulation development, filament extrusion, printing process and printer design. Ther Innov Regul Sci. 56(6):910–928. doi: 10.1007/s43441-021-00354-0.
  • Saerens L, Ghanam D, Raemdonck C, Francois K, Manz J, Krüger R, Krüger S, Vervaet C, Remon JP, De Beer T. 2014. In-line solid state prediction during pharmaceutical hot-melt extrusion in a 12 mm twin screw extruder using Raman spectroscopy. Eur J Pharm Biopharm. 87(3):606–615. doi: 10.1016/j.ejpb.2014.03.002.
  • Shen YC. 2011. Terahertz pulsed spectroscopy and imaging for pharmaceutical applications: a review. Int J Pharm. 417(1–2):48–60. doi: 10.1016/j.ijpharm.2011.01.012.
  • Silge A, Weber K, Cialla-May D, Müller-Bötticher L, Fischer D, Popp J. 2022. Trends in pharmaceutical analysis and quality control by modern Raman spectroscopic techniques. Trends Anal Chem. 153:116623. doi: 10.1016/j.trac.2022.116623.
  • Tolles WM, Nibler JW, McDonald JR, Harvey AB. 1977. A review of the theory and application of coherent anti-Stokes Raman spectroscopy (CARS). Appl Spectrosc. 31(4):253–271. doi: 10.1366/000370277774463625.
  • Vynckier AK, Dierickx L, Voorspoels J, Gonnissen Y, Remon JP, Vervaet C. 2014. Hot-melt co-extrusion: requirements, challenges and opportunities for pharmaceutical applications. J Pharm Pharmacol. 66(2):167–179. doi: 10.1111/jphp.12091.

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.