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Characterization of surface properties of glass vials used as primary packaging material for parenterals.
Journal article

Characterization of surface properties of glass vials used as primary packaging material for parenterals.

  • Ditter D Late Stage Pharmaceutical and Processing Development, Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, 4070 Basel, Switzerland; Division of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, Klingelbergstrasse 50, 4056 Basel, Switzerland; Division of Pharmaceutical Technology, Goethe University of Frankfurt, Max-von-Laue-Str. 9, 60323 Frankfurt am Main, Germany.
  • Mahler HC Division of Pharmaceutical Technology, Goethe University of Frankfurt, Max-von-Laue-Str. 9, 60323 Frankfurt am Main, Germany.
  • Roehl H Late Stage Pharmaceutical and Processing Development, Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, 4070 Basel, Switzerland.
  • Wahl M Institute for Surface and Thin Film Analysis GmbH (IFOS), Trippstadter Straße 121, 67663 Kaiserslautern, Germany.
  • Huwyler J Division of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, Klingelbergstrasse 50, 4056 Basel, Switzerland.
  • Nieto A Late Stage Pharmaceutical and Processing Development, Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, 4070 Basel, Switzerland.
  • Allmendinger A Late Stage Pharmaceutical and Processing Development, Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, 4070 Basel, Switzerland. Electronic address: andrea.allmendinger.aa1@roche.com.
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  • 2018-01-15
Published in:
  • European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V. - 2018
Drug Packaging
Glass
Parenteral Nutrition Solutions
Pharmaceutical Preparations
Surface Properties
English The appropriate selection of adequate primary packaging, such as the glass vial, rubber stopper, and crimp cap for parenteral products is of high importance to ensure product stability, microbiological quality (integrity) during storage as well as patient safety. A number of issues can arise when inadequate vial material is chosen, and sole compliance to hydrolytic class I is sometimes not sufficient when choosing a glass vial. Using an appropriate pre-treatment, such as surface modification or coating of the inner vial surface after the vial forming process the glass container quality is often improved and interactions of the formulation with the surface of glass may be minimized. This study aimed to characterize the inner surface of different type I glass vials (Exp33, Exp51, Siliconized, TopLyo™ and Type I plus®) at the nanoscale level. All vials were investigated topographically by colorimetric staining and Scanning Electron Microscopy (SEM). Glass composition of the surface was studied by Time-of-Flight - Secondary Ion Mass Spectrometry (ToF-SIMS) and X-ray Photoelectron Spectroscopy (XPS), and hydrophobicity/hydrophilicity of the inner surface was assessed by dye tests and surface energy measurements. All containers were studied unprocessed, as received from the vendor, i.e. in unwashed and non-depyrogenized condition. Clear differences were found between the different vial types studied. Especially glass vials without further surface modifications, like Exp33 and Exp51 vials, showed significant (I) vial-to-vial variations within one vial lot as well as (II) variations along the vertical axis of a single vial when studying topography and chemical composition. In addition, differences and heterogeneity in surface energy were found within a given tranche (circumferential direction) of Exp51 as well as Type I plus® vials. Most consistent quality was achieved with TopLyo™ vials. The present comprehensive characterization of surface properties of the different vial types may serve as basis to further guide the selection of adequate primary packaging based on the desired quality target product profile and to support studies of glass surface interactions with formulations. The proposed analytical method panel can be used for characterization of future glass vials either before delivery to the manufacturer or drug product manufacturing.
Language
  • English
Open access status
closed
Identifiers
Persistent URL
https://folia.unifr.ch/global/documents/53752
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