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Novel Cleaning-in-Place Strategies for Pharmaceutical Hot Melt Extrusion.
Pharmaceutics. 2020 Jun 24; 12(6)P

Abstract

To avoid any type of cross-contamination, residue-free production equipment is of utmost importance in the pharmaceutical industry. The equipment cleaning for continuous processes such as hot melt extrusion (HME), which has recently gained popularity in pharmaceutical applications, necessitates extensive manual labour and costs. The present work tackles the HME cleaning issue by investigating two cleaning strategies following the extrusion of polymeric formulations of a hormonal drug and for a sustained release formulation of a poorly soluble drug. First, an in-line quantification by means of UV-Vis spectroscopy was successfully implemented to assess very low active pharmaceutical ingredient (API) concentrations in the extrudates during a cleaning procedure for the first time. Secondly, a novel in-situ solvent-based cleaning approach was developed and its usability was evaluated and compared to a polymer-based cleaning sequence. Comparing the in-line data to typical swab and rinse tests of the process equipment indicated that inaccessible parts of the equipment were still contaminated after the polymer-based cleaning procedure, although no API was detected in the extrudate. Nevertheless, the novel solvent-based cleaning approach proved to be suitable for removing API residue from the majority of problematic equipment parts and can potentially enable a full API cleaning-in-place of a pharmaceutical extruder for the first time.

Authors+Show Affiliations

Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.Evestra Inc., 6410 Tri County Parkway, Schertz, TX 78154, USA.Evestra Inc., 6410 Tri County Parkway, Schertz, TX 78154, USA.ColVisTec AG, Max-Planck-Straβe 3, 12489 Berlin, Germany.Leistritz Extrusionstechnik GmbH, Markgrafenstraβe 38, 90459 Nuremberg, Germany.Leistritz Extrusionstechnik GmbH, Markgrafenstraβe 38, 90459 Nuremberg, Germany.Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria. Institute of Process and Particle Engineering, Graz University of Technology, Inffeldgasse 13, 8010 Graz, Austria.Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria. Institute of Process and Particle Engineering, Graz University of Technology, Inffeldgasse 13, 8010 Graz, Austria.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32599822

Citation

Spoerk, Martin, et al. "Novel Cleaning-in-Place Strategies for Pharmaceutical Hot Melt Extrusion." Pharmaceutics, vol. 12, no. 6, 2020.
Spoerk M, Koutsamanis I, Matić J, et al. Novel Cleaning-in-Place Strategies for Pharmaceutical Hot Melt Extrusion. Pharmaceutics. 2020;12(6).
Spoerk, M., Koutsamanis, I., Matić, J., Eder, S., Patricia Alva Zúñiga, C., Poms, J., Urich, J. A. A., Andreína Lara García, R., Nickisch, K., Eggenreich, K., Berghaus, A., Reusch, K., Relle, Y., Khinast, J., & Paudel, A. (2020). Novel Cleaning-in-Place Strategies for Pharmaceutical Hot Melt Extrusion. Pharmaceutics, 12(6). https://doi.org/10.3390/pharmaceutics12060588
Spoerk M, et al. Novel Cleaning-in-Place Strategies for Pharmaceutical Hot Melt Extrusion. Pharmaceutics. 2020 Jun 24;12(6) PubMed PMID: 32599822.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Novel Cleaning-in-Place Strategies for Pharmaceutical Hot Melt Extrusion. AU - Spoerk,Martin, AU - Koutsamanis,Ioannis, AU - Matić,Josip, AU - Eder,Simone, AU - Patricia Alva Zúñiga,Carolina, AU - Poms,Johannes, AU - Urich,Jesús Alberto Afonso, AU - Andreína Lara García,Raymar, AU - Nickisch,Klaus, AU - Eggenreich,Karin, AU - Berghaus,Andreas, AU - Reusch,Kathrin, AU - Relle,Yorick, AU - Khinast,Johannes, AU - Paudel,Amrit, Y1 - 2020/06/24/ PY - 2020/05/29/received PY - 2020/06/17/revised PY - 2020/06/20/accepted PY - 2020/7/1/entrez PY - 2020/7/1/pubmed PY - 2020/7/1/medline KW - API contamination KW - UV–Vis spectroscopy KW - cleaning verification KW - cleaning-in-place KW - estradiol KW - estriol KW - hot melt extrusion KW - ibuprofen KW - process analytical technology KW - swab and rinse tests JF - Pharmaceutics JO - Pharmaceutics VL - 12 IS - 6 N2 - To avoid any type of cross-contamination, residue-free production equipment is of utmost importance in the pharmaceutical industry. The equipment cleaning for continuous processes such as hot melt extrusion (HME), which has recently gained popularity in pharmaceutical applications, necessitates extensive manual labour and costs. The present work tackles the HME cleaning issue by investigating two cleaning strategies following the extrusion of polymeric formulations of a hormonal drug and for a sustained release formulation of a poorly soluble drug. First, an in-line quantification by means of UV-Vis spectroscopy was successfully implemented to assess very low active pharmaceutical ingredient (API) concentrations in the extrudates during a cleaning procedure for the first time. Secondly, a novel in-situ solvent-based cleaning approach was developed and its usability was evaluated and compared to a polymer-based cleaning sequence. Comparing the in-line data to typical swab and rinse tests of the process equipment indicated that inaccessible parts of the equipment were still contaminated after the polymer-based cleaning procedure, although no API was detected in the extrudate. Nevertheless, the novel solvent-based cleaning approach proved to be suitable for removing API residue from the majority of problematic equipment parts and can potentially enable a full API cleaning-in-place of a pharmaceutical extruder for the first time. SN - 1999-4923 UR - https://www.unboundmedicine.com/medline/citation/32599822/Novel_Cleaning-in-Place_Strategies_for_Pharmaceutical_Hot_Melt_Extrusion L2 - https://www.mdpi.com/resolver?pii=pharmaceutics12060588 DB - PRIME DP - Unbound Medicine ER -
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