In-line monitoring of solid dispersion preparation in small scale extrusion based on UV–vis spectroscopy

References

• Almeida J, Bezerra M, Markl D, Berghaus A, Borman P, Schlindwein W. 2020. Development and validation of an in-line API quantification method using AQbD principles based on UV–vis spectroscopy to monitor and optimise continuous hot melt extrusion process. Pharmaceutics. 12(2):150.
   PubMed Web of Science ®Google Scholar
• Baghel S, Cathcart H, O'Reilly NJ. 2016. Polymeric amorphous solid dispersions: a review of amorphization, crystallization, stabilization, solid-state characterization, and aqueous solubilization of biopharmaceutical classification system class II drugs. J Pharm Sci. 105(9):2527–2544.
   PubMed Web of Science ®Google Scholar
• Bhujbal SV, Mitra B, Jain U, Gong Y, Agrawal A, Karki S, Taylor L, Kumar S, Zhou Q. 2021. Pharmaceutical amorphous solid dispersion: a review of manufacturing strategies. Acta Pharm Sin B. 11(8):2505–2536.
   PubMed Web of Science ®Google Scholar
• Byrn SR, Zografi GD, Chen S. 2017. Solid state properties of pharmaceutical materials. Hoboken (NJ): Wiley.
   Google Scholar
• Gilmor C, Balke ST, Calidonio F, Rom-Roginski A. 2003. In-line color monitoring of polymers during extrusion using a charge coupled device spectrometer: color changeovers and residence time distributions. Polym Eng Sci. 43(2):356–368.
   Web of Science ®Google Scholar
• Gordillo B, Ciaccheri L, Mignani AG, Gonzalez‐Miret ML, Heredia FJ. 2011. Influence of turbidity grade on color and appearance of virgin olive oil. J Am Oil Chem Soc. 88(9):1317–1327.
   Web of Science ®Google Scholar
• Gottschalk T, Grönniger B, Ludwig E, Wolbert F, Feuerbach T, Sadowski G, Thommes M. 2022. Influence of process temperature and residence time on the manufacturing of amorphous solid dispersions in hot melt extrusion. Pharm Dev Technol. 27(3):1–6.
   PubMed Web of Science ®Google Scholar
• Hancock BC, Parks M. 2000. What is the true solubility advantage for amorphous pharmaceuticals? Pharm Res. 17(4):397–404.
   PubMed Web of Science ®Google Scholar
• Haser A, Haight B, Berghaus A, Machado A, Martin C, Zhang F. 2018. Scale-up and in-line monitoring during continuous melt extrusion of an amorphous solid dispersion. AAPS PharmSciTech. 19(7):2818–2827.
   PubMed Web of Science ®Google Scholar
• Hitzer P, Bäuerle T, Drieschner T, Ostertag E, Paulsen K, van Lishaut H, Lorenz G, Rebner K. 2017. Process analytical techniques for hot-melt extrusion and their application to amorphous solid dispersions. Anal Bioanal Chem. 409(18):4321–4333.
   PubMed Web of Science ®Google Scholar
• Lillotte TD, Joester M, Frindt B, Berghaus A, Lammens RF, Wagner KG. 2021. UV–vis spectra as potential process analytical technology (PAT) for measuring the density of compressed materials: evaluation of the CIELAB color space. Int J Pharm. 603:120668.
   PubMedGoogle Scholar
• Moseson DE, Taylor LS. 2018. The application of temperature-composition phase diagrams for hot melt extrusion processing of amorphous solid dispersions to prevent residual crystallinity. Int J Pharm. 553(1–2):454–466.
   PubMedGoogle Scholar
• Rodriguez-Aller M, Guillarme D, Veuthey J-L, Gurny R. 2015. Strategies for formulating and delivering poorly water-soluble drugs. J Drug Deliv Sci Technol. 30:342–351.
   Web of Science ®Google Scholar
• Saerens L, Vervaet C, Remon JP, Beer Td 2014. Process monitoring and visualization solutions for hot-melt extrusion: a review. J Pharm Pharmacol. 66(2):180–203.
   PubMed Web of Science ®Google Scholar
• Sakai T, Thommes M. 2014. Investigation into mixing capability and solid dispersion preparation using the DSM Xplore Pharma Micro Extruder. J Pharm Pharmacol. 66(2):218–231.
   PubMed Web of Science ®Google Scholar
• Schittny A, Huwyler J, Puchkov M. 2020. Mechanisms of increased bioavailability through amorphous solid dispersions: a review. Drug Deliv. 27(1):110–127.
   PubMed Web of Science ®Google Scholar
• Schlindwein W, Bezerra M, Almeida J, Berghaus A, Owen M, Muirhead G. 2018. In-line UV–vis spectroscopy as a fast-working process analytical technology (PAT) during early phase product development using hot melt extrusion (HME). Pharmaceutics. 10(4):166.
   PubMed Web of Science ®Google Scholar
• Spoerk M, Koutsamanis I, Matić J, Eder S, Patricia Alva Zúñiga C, Poms J, Urich JAA, Andreína Lara García R, Nickisch K, Eggenreich K, et al. 2020. Novel cleaning-in-place strategies for pharmaceutical hot melt extrusion. Pharmaceutics. 12(6):588.
   PubMed Web of Science ®Google Scholar
• Ting JM, Porter WW, Mecca JM, Bates FS, Reineke TM. 2018. Advances in polymer design for enhancing oral drug solubility and delivery. Bioconjug Chem. 29(4):939–952.
   PubMed Web of Science ®Google Scholar
• Vasconcelos T, Sarmento B, Costa P. 2007. Solid dispersions as strategy to improve oral bioavailability of poor water soluble drugs. Drug Discov Today. 12(23–24):1068–1075.
   PubMed Web of Science ®Google Scholar
• Wahl PR, Treffer D, Mohr S, Roblegg E, Koscher G, Khinast JG. 2013. Inline monitoring and a PAT strategy for pharmaceutical hot melt extrusion. Int J Pharm. 455(1–2):159–168.
   PubMedGoogle Scholar
• Wesholowski J, Berghaus A, Thommes M. 2018. Inline determination of residence time distribution in hot-melt-extrusion. Pharmaceutics. 10(2):49.
   PubMed Web of Science ®Google Scholar
• Wesholowski J, Prill S, Berghaus A, Thommes M. 2018. Inline UV/vis spectroscopy as PAT tool for hot-melt extrusion. Drug Deliv Transl Res. 8(6):1595–1603.
   PubMed Web of Science ®Google Scholar
• Wolbert F, Fahrig I-K, Gottschalk T, Luebbert C, Thommes M, Sadowski G. 2022. Factors influencing the crystallization-onset time of metastable ASDs. Pharmaceutics. 14(2):269.
   PubMed Web of Science ®Google Scholar