Novel Cleaning-in-Place Strategies for Pharmaceutical Hot Melt Extrusion.
API contamination
UV–Vis spectroscopy
cleaning verification
cleaning-in-place
estradiol
estriol
hot melt extrusion
ibuprofen
process analytical technology
swab and rinse tests
Journal
Pharmaceutics
ISSN: 1999-4923
Titre abrégé: Pharmaceutics
Pays: Switzerland
ID NLM: 101534003
Informations de publication
Date de publication:
24 Jun 2020
24 Jun 2020
Historique:
received:
29
05
2020
revised:
17
06
2020
accepted:
20
06
2020
entrez:
1
7
2020
pubmed:
1
7
2020
medline:
1
7
2020
Statut:
epublish
Résumé
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
Identifiants
pubmed: 32599822
pii: pharmaceutics12060588
doi: 10.3390/pharmaceutics12060588
pmc: PMC7356020
pii:
doi:
Types de publication
Journal Article
Langues
eng
Subventions
Organisme : Österreichische Forschungsförderungsgesellschaft
ID : COMET
Organisme : Österreichische Forschungsförderungsgesellschaft
ID : COMET
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