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The market for prefillable syringe systems (PFS) is growing at a rate of approximately 10 percent per year, with cartridge-based systems growing even faster at rates of 13 percent (2013 market outlook, IMS). The predominant areas of growth are within the insulin and biologics therapeutic areas, as well as overall growth within emerging markets.
As patient needs evolve based on convenience, ease of use and home delivery of injectable drug products, prefilled drug delivery solutions, including injection systems based on prefilled cartridges will continue to grow. New device technology for self-injection will allow for safe administration, flexible dosing and, potentially, better patient compliance. An example of a common drug product delivered in cartridge form is the insulin product Lantus®, which uses the SoloSTAR® pen device. Lantus SoloSTAR demonstrates the benefit of cartridge delivery paired with a device by leveraging the “dial a dose” feature and ease of use offered by a pen injector as well as the small thin needles required for injection. Lantus SoloSTAR also provides more dosing units per prescription compared to single dose vial and syringe delivery which provides patients with more medication for the same co-pay.
For pharmaceutical manufacturers, new fill-finish technology allows for a flexible design to fit multiple container systems (vial, PFS, cartridge). However, component processing is a source of risk for cartridge components, just as it is for syringe or vial components. To help simplify drug development and streamline manufacturing, pharmaceutical manufacturers should select cartridge plungers and lined seals in ready-to-use formats.
West’s industry proven Westar® component processing reduces the risk of variability and the potential effects on drug quality, safety and efficacy. Westar RU cartridge components include 1.5mL and 3mL cartridge plungers and 8mm monolayer lined seals (for puncture applications less than five punctures) and 8 mm laminate lined seals (for greater than five punctures).
These product offerings are ideal for companies developing new products in the insulin space or for companies with existing insulin products that understand the advantages associated with ready-to-use components. The laminate-lined seal is designed especially for insulin products requiring multi-dose applications and has been tested at greater than 100 punctures.
Lantus® and SoloStar® are registered trademarks of sanofi-aventis U.S. LLC
Westar® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
<p style="margin: 0in 0in 10pt;">The new regulation “Bundling Review and Approval of Packaging and Excipients with Drug Products” announced by the China Federal Drug Administration (CFDA) on August 10, 2016, has generated both interest and concern. While the CFDA has published several related guidelines in an effort to address questions, many still persist. </p>
Regulatory agencies are driving the pharmaceutical industry to continuously improve the quality of drug products, but what is the reality for a drug developer who is expected to make parenteral preparations “practically free from particles”? Expectations of packaging are changing fast but how well prepared is the packaging to meet these needs?
In Part I of this two-part series, several of the challenges with USP<789> <em>Particulate Matter in Ophthalmic Solutions</em> were discussed. Namely, the limits were established before routine intravitreal injections existed and the same acceptance criteria are applied to two different particle detection methods with different capabilities. Other challenges include the mismatch between required analysis volume and the very small fill volumes of ophthalmic injections and the lack of translatable limits for the syringe system alone. Regardless of the potential gaps in the pharmacopeial chapter, it is nevertheless clear that for ophthalmic injections, the industry expectations are to strive for the lowest possible visible and subvisible particle levels that are achievable.
West’s Diane Paskiet, Doug Duriez and Gene Polini are among the authors in the recently published <a href="http://www.crcpress.com/product/isbn/9781841848198?utm_medium=Email&utm_source=ExactTarget&utm_term=&utm_content=http://view.email.taylorandfrancis.com/?j=fec615707d62037e&utm_campaign=HLM33E_Encyc_Pharm_Science"><em><span style="text-decoration: underline;">Encyclopedia of Pharmaceutical Science and Technology, Fourth Edition</span></em></a>.
At West, we are by the side of our team members - supporting your training and development needs, providing opportunities to advance in your career and reach your full potential, while maintaining your well-being and work-life balance. In our Team Member Spotlight, learn more about what it is like to work at West and hear about the experiences and careers of some of our team members around the world.
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