to Silicone Oill Evaluating 82-Coating as an Alternative
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`I.Overview
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`In an effort to support customers of West Pharmaceutical Services who may be evaluating
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`82-Coating as an alternative to silicone oil on an already approved drug product, West
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`Pharmaceutical Services' Technical Customer Services Group lists the following factors to help you
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`decide what may be appropriate in your evaluation and submission processes.
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`of the structure and backbone The polymeric silicone coating. 1.) 82-Coating is a polymerized,
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`coating is, therefore, very similar to traditional silicone oil. There is a Drug Master File on this
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`coating that the FDA can refer to upon receipt of your submission. Contact West's
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`Regulatory Group for an authorization letter allowing access to this DMF. Additionally, West
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`has conducted specialized lntracutaneous and Systemic toxicity testing of the coating and its
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`high molecular weight silicone components. A summary of this work can be found in West's
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`Technical Report# 2000/038.
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`(lubricity oil coated closures found with silicone that are normally 2.) In addition to the benefits
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`and processability) the 82 minimizes the characteristics associated with the silicone oil
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`treated stoppers (particles in solution, inconsistent application). Various technical reports
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`detailing the characteristics of 82-Coating are available from West's Technical Customer
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`Services Group.
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`against a comparable should be equivalent 3.) The extractable profile of your 82 coated closure
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`silicone oil coated closure. Although the 82-Coating is not presented to the market as having
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`"barrier" characteristics, testing has shown the coating to exhibit lower extractables.
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`to oil treated West formulation 4.) It is recommended that, should you be moving from a silicone
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`a 82 coated version of the same formula, you g:enerate
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`real-time and accelerated stability
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`data. At the completion of the accelerated study, the suitability of the coating for future
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`product use should be determined. Notification of the regulatory agency at this time is
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`II.Summary
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`This technical bulletin dated 26 January 1999, supersedes any other previously released versions
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`The information given in this Technical Support Bulletin is to be used as a general reference guide
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`only. West Pharmaceutical Serviices warrants that its services will be performed according to all
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`specified methods and testing procedures, including current Good Manufacturing Practices, where
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`applicable. West Pharmaceutical Services' products are sold on the basis that it is the customer's
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`responsibility to evaluate and test the West product to determine its compatibility with other
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`materials and fitness for any end use.
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`of this bulletin.
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`82-Coating technology is licensed from Daikyo Seiko, Ltd.
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`©1999 by West Pharmaceutical Services, Inc.
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`All rights reserved. This material is protected by copyright. No part of it may be
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`Bass and Spangenberg
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`reproduced, stored in a retrieval system. or transmitted in any form or by any
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`means, electronic, mechanical, photocopying or otherwise, without written
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`Fresenius Kabi USA
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`permission of West Pharmaceutical Services, Inc.
`U.S. Patent No. 8,476,010
`Exhibit 1011
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`Page 1 of 1
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`1999/013 r Technical Support Bulletin
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`26 Jan 1999
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`Exh. 1011