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A key element of West’s commitment to a safe and efficient delivery of drug products is staying abreast of industry developments, and being prepared to help customers navigate them. Recently Dow Corning introduced a new product - Dow Corning® 366 35% Dimethicone NF Emulsion.
This is an update of their 365 35% Dimethicone NF Emulsion. The difference is that 366 does not use a surfactant listed on the European Chemicals Agency REACh (Registration, Evaluation, Authorization and Restriction of Chemicals) Authorization List. In contrast, 365 does– polyethylene glycol tert-octylphenyl ether (TritonTM X-100). These silicone-based products are widely used in the lubrication of glass syringe barrels.
Dow Corning currently does not plan to discontinue 365 for those customers who have already qualified it and will continue to use it. But, for customers who decide to use 366, West is well prepared to provide support in qualification through Analytical Lab Services – from filling syringes, to performance evaluation, to evaluation of targeted leachables, and evaluation of interactions with drug product. West has everything needed to design and execute the experiments needed – state-of-the-art facilities [e.g., Inductively Coupled Plasma Mass Spectroscopy (ICP/MS)] and experienced staff with the right expertise.
For more information, contact an Account Manager, Technical Customer Support (TCS) representative or visit our Integrated Solutions program page.
Simplify the Journey™ is a trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
Dow Corning® is a registered trademark of Dow Corning Corporation.
Triton™ is a trademark of The Dow Chemical Company.
West is committed to the safe and efficient delivery of drug products to patients. Key to this is not only staying abreast of industry developments, but also being prepared to help customers address them. This is a focus of the Integrated Solutions platform.
As China has become the fastest-growing market in generic drugs, China Food and Drug Administration (CFDA) is paying more attention to drug quality and setting a higher standard for pharmaceutical packaging. Compatibility of the drug with the packaging materials is one critical focus area.<br />
To support customers as they navigate the path from drug product discovery to commercialization, West has undertaken a new, proactive strategy: <em>Integrated Solutions.</em> For almost 100 years, West has been developing technical and regulatory expertise in primary drug packaging, delivery devices, and combination products. That wealth of industry experience is now offered to customers who can employ it for any stage of development (Prescreen and Compatibility, Clinical Phases I / II / III, and Lifecycle Management).
West is now celebrating the one-year anniversary of its Integrated Solutions initiative, known as Simplify the Journey™. Throughout 2019, we socialized the program through marketing materials and face-to-face conversations with customers. Now it’s time to reflect on the lessons we’ve learned — and to look forward to the opportunities on the horizon.
Pharmaceutical industry focus on issues of extractables and leachables from packaging/delivery systems began during the mid-1990’s. Since then, regulatory agencies have become more educated, and drug product formulations have become more complex, which makes the need for a robust extractables and leachables program that much more critical. Failure to properly evaluate extractables and leachables has had a negative impact on many pharmaceutical companies, e.g., late-stage stability failures, submission delays, and recalls. To avoid this, the question is – where to start?
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