Performance stability of silicone oxide-coated plastic parenteral vials

Christopher M. Weikart, Carlo G. Pantano, Jeff R. Shallenberger

Research output: Contribution to journalArticlepeer-review

9 Scopus citations

Abstract

A new packaging system was developed for parenteral pharmaceuticals that combines the best attributes of plastic and glass without their respective drawbacks. This technological advancement is based on the synergy between high-precision injection-molded plastics and plasma coating technology. The result is a shatter-resistant, optically clear, low-particulate, and chemically durable packaging system. The demand for this product is driven by the expanding market, regulatory constraints, and product recalls for injectable drugs and biologics packaged in traditional glass materials. It is shown that this new packaging system meets or exceeds the important performance characteristics of glass, especially in eliminating the glass delamination and breakage that has been observed in many products. The new packaging system is an engineered, multilayer, glass-coated plastic composite that provides a chemically stable contact surface and oxygen barrier performance that exceeds a 2 year shelf life requirement. Evaluation of the coating system characteristics and performance stability to chemical, temperature, and mechanical extremes are reported herein.

Original languageEnglish (US)
Pages (from-to)317-327
Number of pages11
JournalPDA Journal of Pharmaceutical Science and Technology
Volume71
Issue number4
DOIs
StatePublished - Jul 1 2017

All Science Journal Classification (ASJC) codes

  • Pharmaceutical Science

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