A New Glass Option for Parenteral Packaging

Schaut, Robert A.; Peanasky, John; DeMartino, Steven E.; Schiefelbein, Susan L.

doi:10.5731/pdajpst.2014.00998

Cited by 26 publications

(10 citation statements)

References 9 publications

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“…The undisputed Achilles heel of glass has long been breakage and is unlikely to change despite attempts to improve it. 27,28 Although fused quartz has remarkably high thermal shock resistance, its mechanical toughness, as measured by its compressive and tensile strength, is inferior to borosilicate glass, as shown in Table 1 . Furthermore, pure silica is impractical for manufacturing high-volume commodity containers because of its extremely high glass transition temperature (T g ).…”

Section: Resultsmentioning

confidence: 99%

Hybrid Blood Collection Tubes: Combining the Best Attributes of Glass and Plastic for Safety and Shelf life

Weikart¹,

Breeland²,

Wills³

et al. 2020

SLAS Technology

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SiO2 Medical Products, Inc. developed hybrid blood collection tubes (BCTs) that combine the breakage resistance of plastic and a shelf life approaching that of glass. These blended attributes provide improved BCT safety and reliability for patients and clinical workers. A shelf life of at least 2 y with less than 10% draw volume variation was demonstrated on evacuated hybrid BCTs, which is approximately 7 times longer than standard polyethylene terephthalate (PET) BCTs. This translates into more consistent and reliable blood draw volumes over a longer shelf life. The moisture vapor barrier of hybrid BCTs is 5 times lower than that of PET BCTs, which significantly reduces preservative evaporation over their shelf life. As a result, the risk of preservative gelation and alteration to the blood-to-preservative ratio mix is practically eliminated. Cyclic olefin polymer (COP) exhibits superior impact resistance to breakage because of its high ductility and impact strength and is not influenced by defects and flaws as is glass. Although COP has a mechanical toughness comparable with that of PET, it maintains this over a wider range of temperatures (–70 to 121 °C). As a result, COP can tolerate steam sterilization and cold storage temperatures without mechanical fatigue, deformation, or breakage. Lastly, extreme centrifugation of water-filled BCTs did not impose breakage of any kind.

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Section: Resultsmentioning

confidence: 99%

Hybrid Blood Collection Tubes: Combining the Best Attributes of Glass and Plastic for Safety and Shelf life

Weikart¹,

Breeland²,

Wills³

et al. 2020

SLAS Technology

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show abstract

“…Several new glass surfaces have been developed [75,76]. Alkali aluminosilicate glasses or aluminosilicate glasses have been introduced as possible alternatives to alkali borosilicate glasses.…”

Section: Syringe Barrelmentioning

confidence: 99%

Development of syringes and vials for delivery of biologics: current challenges and innovative solutions

Yoneda

Torisu

Uchiyama

2021

Expert Opinion on Drug Delivery

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Introduction: Several new biopharmaceutical dosage forms have developed over time, such as lyophilized vial, liquid vial, and liquid prefilled syringe formulations. This review summarizes major pharmaceutical dosage forms and their advantages, disadvantages, and countermeasures against the shortcomings of each formulation. The appropriate combination of active pharmaceutical ingredients, excipients, and containers should be selected for the safe and less burdensome administration to the patients. Finally, we note certain opinions on the future development of not only therapeutic proteins but also gene therapeutics.Areas covered: This review is to discuss the challenges of the development of dosage forms to improve pharmaceutical stability and how they can be overcome. Expert opinion: Silicone oil-free syringes are highly preferable for minimizing subvisible particles in the drug. It can be proposed that materials with less protein adsorption property are preferable for the suppression of protein aggregation. It is required to minimize adverse effects of biopharmaceuticals through proper quality control of the drug in a container, based on the understating of physicochemical stability of the protein in solution, the physicochemical properties of the container, and their combinations.

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“…Specifically, there are reports of changes to existing borosilicate compositions to improve hydrolytic durability (38,104,105). There are also new compositions that have similar chemical durability without boron for preventing delamination (105)(106)(107). A third category of containers places the drug in contact with glassy silicon dioxide coatings or similar materials aiming to improve breakage (108), chemical durability (109), or delamination (108 -110).…”

Section: What's Next: Advances In Glass Composition Performance Andmentioning

confidence: 99%

Historical Review of Glasses Used for Parenteral Packaging

Schaut

Weeks

2017

PDA Journal of Pharmaceutical Science and Technology

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Glass has long been used for packaging precious liquids, in particular pharmaceuticals. Its unique combination of hermeticity, transparency, strength, and chemical durability make it the optimal material for such an important role. Today's life-saving drugs are stored in borosilicate glasses, which evolved from applications in microscope optics and thermometers. As the glass compositions improved, so did the methods used to shape them and the tests used to characterize them. While all of these advances improved the quality of the glass container and its ability to protect the contents, problems still exist such as delamination, cracks, and glass particulates. In addition to these issues, we review new developments in glass composition development, performance, and testing in the 21 century.

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A New Glass Option for Parenteral Packaging

Cited by 26 publications

References 9 publications

Hybrid Blood Collection Tubes: Combining the Best Attributes of Glass and Plastic for Safety and Shelf life

Hybrid Blood Collection Tubes: Combining the Best Attributes of Glass and Plastic for Safety and Shelf life

Development of syringes and vials for delivery of biologics: current challenges and innovative solutions

Historical Review of Glasses Used for Parenteral Packaging

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