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This is the second in a two part series dedicated to the origins and attributes of the Daikyo Crystal Zenith® polymer
The Daikyo Crystal Zenith® polymer is a custom formulated cyclic olefin polymer developed by Masamichi Sudo, who made it his life’s work to improve all aspects of parenteral packaging. He started by creating safe closure solutions like B2 lubricious coating and FluroTec®, a fluoropolymer lamination to protect both elastomer and drug product from each other. Enormously successful, these technologies paved the way toward the creation of the Daikyo Crystal Zenith (CZ) polymer.
Probably the most salient feature of CZ is its outstanding barrier properties. CZ outperforms many plastics with respect to this important parameter. One of the most deleterious gases to parenteral pharmaceutical products is oxygen. Many drug products are subject to oxidative reduction and therefore must be protected from oxygen throughout their shelf life. CZ has better oxygen permeability properties than many of its peer polymers such as polypropylene, polystyrene and polycarbonate.
In addition to good oxygen barrier, CZ provides protection against the next most deleterious material to many drug products: water vapor. This is a plus for manufacturers that are packaging non-aqueous and dry drug products.
Several studies have been performed that indicate CZ is a good candidate for moisture sensitive products. This property is inherent to CZ thanks to its nonpolar material properties.
The next area of concern for packaging scientists is leachables and extractables. While CZ is free of inorganic extractables (unlike glass), how does it stack up against its peer polymeric packaging materials? Data indicates CZ has low organic extractables especially when compared to other plastic packaging materials.
Finally, it helps to be sure that the selected packaging materials do not selectively aggregate, sequester, absorb or adsorb the important active and excipient material in the drug product. It is well known that some plastics can completely remove some excipients from the drug product, the result being instability and shorter shelf life.
This table details the amounts of three widely used preservatives measured in solution after 90 days of storage. Values over 100 percent indicate experimental error. Note CZ is equivalent to glass and superior to polypropylene in regard to sorption of these model preservatives.
A CZ system can mitigate some of the many issues pharmaceutical manufacturers may encounter with current packaging. These companies have their hands full with the research, development, clinical trials, regulatory submissions, marketing and production of the drug product. By working with West, researchers are able to leverage our expertise with primary containers and focus on the drug product itself.
The use of proteins as therapeutics has focused attention on the need to maintain the stability of these labile molecules during both storage and shipment. The trend in the pharmaceutical industry has been to package therapeutic proteins in prefillable syringes made of glass. However, some biologics are not stable in glass syringes due to sensitivity to adhesives used in their manufacture and to tungsten oxides generated during needle placement.
Polymeric container systems are not new to the pharmaceutical industry, and their benefits in terms of break resistance, cosmetic quality and dimensional precision have been recognized by many companies around the world who have chosen to use a polymer vial or syringe.
<p><strong>Part I</strong></p><p><em>This is a first in a two part series dedicated to the origins and attributes of the Daikyo Crystal Zenith® Polymer </em></p><p>In the early 1990s, Masamichi Sudo, founder and past president of Daikyo Seiko, Ltd., first developed the Daikyo Crystal Zenith polymer. This custom formulated cyclic olefenic polymer, available today in the Daikyo Crystal Zenith (CZ) portfolio of products offered by West, represents his lifelong ambition to improve all aspects of parenteral packaging and commitment to delivering the most precise formulation to the marketplace.</p>
Nuclear medicine has been extensively used not only to diagnose but also to treat diseases. Radio-labeled proteins and peptides are widely used for this purpose, and glass vials have been traditionally used to store radio-labeled pharmaceutical parenteral dosage forms. One important factor for successful use of the container closure systems (CCS) is how precisely and efficiently the radiopharmaceutical solution is withdrawn from the sealed container. However, due to the generally hydrophobic nature of these compounds, chemical reactions, including product synthesis and purification processes, are often complicated and costly. Overcoming the potential for adsorption of these compounds to the surface of the CCS is key to maximizing the effectiveness of radiopharmaceuticals.
Daikyo Crystal Zenith® (CZ) Pre-Fillable Syringe (PFS) systems were designed to maintain purity, integrity, and efficacy of premium biopharmaceutical therapies. The system minimizes the potential contamination issues associated with glass and helps to reduce the risk of product interactions, delays in development and scale up, and possible recalls. As an extension of the existing 1mL Long Insert Needle Barrel Assembly, West and Daikyo are proud to introduce the new 2.25mL Insert Needle (IN), providing drug manufacturers a larger volume option for the next generation of autoinjectors for at-home therapies.
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