Suitability of a container/delivery system for a drug product depends upon the chemical/physical properties of the system’s materials of construction (glass, polymer, elastomer)—such as interaction with drug product, gas permeability and durability through temperature cycles. This section presents papers on these and similar topics.
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In order to mitigate health care worker’s risk of exposure to hazardous injectable drugs during the transfer from vial to device, it is necessary to consider the right combination of vial stopper and spike. This investigation serves to understand issue of spikes pushing stoppers into the vial. It shows that the push-in force limit varies with the spike size, stopper materials and design. The spike puncture force is impacted by spike design, surface lubricity, stopper materials and design. Stopper push-in force limit and spike puncture force should be coordinated and optimized to prevent the stopper from being pushed into the vial, causing splashes and exposure to the drug.
Employing both testing evaluation and modeling on a typical 20 mm container closure system, an in-depth case study of critical CCS component compatibility and its impact on CCI quality performance will be demonstrated. The conclusions provide scientific insight into how to proactively consider, control, and maintain a reliable container closure system (CCS) not only for long-lasting CCI quality performance to satisfy patient safety but also visual CCS quality acceptance throughout the entire sealed drug product life cycle.
Discussed is the diffusion of selected organic compounds through cyclic olefin polymer - permeability coefficients are correlated with molecular volume and activation energy of diffusion.
<p><em>F. Welle. International Journal of Pharmaceutics, 473, 510-517 (2014) </em></p>
This article examines the performance of microcentrifuge tubes comprising Daikyo Crystal Zenith® cyclic olefin polymer to those comprising polypropylene. Cyclic olefin polymer tubes perform as well, with the added benefit of a lower extractables profile.
<p><em>L. Waxman, et al. BioTechniques, 62 (5), 223-228 (May 2017)</em></p>
<p>by Liang Feng and Cathy Zhao. <em>PDA Journal of Pharmaceutical Science and Technology</em>. August, 2018</p>
<p>The work presented here uses a new mathematical model to better understand the barrier properties of a model ETFE fluoropolymer film. This model may be used to facilitate expedited screening of potential leachables, allowing for experimental focus on higher-risk leachables and ultimately enabling more rapid combination drug product development.</p>
<p>(Requires PDA login for full article)</p>
<p>This is a review article on ring-opening olefin metathesis polymerization by R.H. Grubbs (California Institute of Technology), 2005 Nobel Laureate in Chemistry. This type of polymerization is employed in the production of cyclic olefin polymers.</p>
<p><em>R.H. Grubbs. Tetrahedron 60, 7117–7140 (2004)</em></p>
<p><span class="product-banner-author">V. Vilivalam and F. DeGrazio. Pharmaceutical Dosage Forms: Parenteral Medications (3rd Ed.), Vol. 1: Formulation and Packaging, 303-323 (2010)</span></p>
<p><span class="product-banner-author">This chapter considers the use of Daikyo Crystal Zenith® cyclic olefin polymers in parenteral packaging and delivery systems. </span></p>
The article cited here considers, experimentally and theoretically, the stress relaxation of elastomers under compression versus time, and how said relaxation may affect container closure integrity of elastomer-stoppered vials.<br />
<em>Q. Zeng and X. Zhao. PDA Journal of Pharmaceutical Science and Technology, 72 (2), 134 - 148 (March-April 2018) </em>
<p>This article describes the many benefits of Daikyo Crystal Zenith<sup>®</sup> cyclic olefin polymer versus glass for low-temperature storage of drug products.</p>
<p><em>W. Winters. Pharmaceutical Online (July 25, 2017)</em></p>