Pre filled Aug 07 - ONdrugDelivery Magazine

1 Pre filled Aug 07 10/10/07 19:21 Page 1. PREFILLED syringes : DEVICE SUPPLIERS MEETING PHARMACEUTICAL STANDARDS. Pre filled Aug 07 10/10/07 19:21 Page 2. Prefilled syringes : device suppliers meeting pharmaceutical standards CONTENTS. This edition is one in a series of sponsored themed publications from ONdrugDelivery Ltd. Each issue focuses on a specific topic within the field of drug delivery, and is supported by industry leaders in that field. Introduction Full contact information appears alongside each article. Guy Furness Contributing companies would be delighted to hear ONdrugDelivery 3-4. from interested readers directly. ONdrugDelivery would also be very pleased to pass on to authors, or answer as appropriate, any queries you might have in The next generation of prefillable syringes : relation to this publication or others in the series. speciaised plastics lead the way Bernie Lahendro During the remainder of 2007 and early 2008, West Pharmaceutical Serivces 6-8.

2 ONdrugDelivery will be covering the following topics: October: Delivering Injectables Pre- filled syringe plungers from RTS to RTU: December: Controlled Release Polymers cleanliness & convenience February: Transdermal Drug Delivery Jean-Pierre Merceille April: Prefilled syringes Stelmi 10-12. June: Pulmonary Drug Delivery SUBSCRIPTIONS: Company profile To arrange your FREE subscription (pdf or print). Ypsomed 15. to ONdrugDelivery 's sponsored series, contact: Nicki Macadam, Marketing & Subscriptions Manager T: +44 (0) 1273 320 279. E: A better fill for prefilled syringes : applications & advantages of bubble-free filling for today's SPONSORSHIP/ADVERTISING: parenteral products To find out more about how your company can become Shawn D. Kinney, PhD. a participant in any of our sponsored issues, contact: Hyaluron Contract Manufacturing 17-20. Guy Furness, Publisher T: +44 (0) 1273 320 279. E: Auto-injection devices: convenience items, or a key component of injectable products?

3 MAILING ADDRESS: Mike Kasprick ONdrugDelivery Ltd, 48, Albany Villas, Hove, Antares Pharma 23-26. East Sussex, BN3 2RW, United Kingdom Prefilled syringes : device suppliers meeting pharma- ceutical requirements is published by ONdrugDelivery Ltd. Registered Office: Cedar Cottage, Newtimber Place Lane, Newtimber, West Sussex, BN6 9BU, United Kingdom. Registered in England: No 05314696. Copyright 2007 ONdrugDelivery Ltd The views and opinions expressed in this issue are those of the authors. Due care has been used in producing this publication, but the publisher makes no claim that it is free of error. Nor does the publisher accept liability for the consequences of any decision or action taken (or not taken) as a result of any information contained in this publication. 2 Copyright 2007 ONdrugDelivery Ltd Pre filled Aug 07 10/10/07 19:21 Page 3. INTRODUCTION. PREFILLED syringes : WHERE HAVE WE GOT TO ?

4 The mood in the prefilled syringes segment was Furthermore, from an initially narrow range of ther- the pharmaceutical industry act, and real commer- upbeat when I first started writing about it four or five apeutic applications in the diabetes, growth hor- cial progress is underway. years ago, and it has continued to be positive since. mone, heparin and emergency injections markets In summary, barriers that prevented polymer Current evidence shows that the prefilled syringes around ten years ago, the application of prefilled syringes from entering the market, such as lack of market is still, and will carry on, expanding steadily. syringes has broadened into the rheumatoid arthritis, optical clarity and questions about shelf life of prod- However, this is not new information for most osteoporosis, multiple sclerosis, cancer, fertility, ucts stored in polymer containers, have now been readers.

5 The major drivers for growth have been anaemia and haemophilia markets, among others. overcome. At the same time the benefits that poly- written about often, continue to be written about While the commercial success of prefilled mer syringes could bring, compared with glass, have often, and still apply today as they did several syringes has continued, the anticipated wave of been recognised. These include: years back. (For a quick reminder of the many fac- products based on non-invasive drug delivery tech- tors driving the prefilled syringes sector, see the nologies especially those for biologics has still increased resistance to breakage summary box on page four.) So, in this article, not arrived. Not in a big way in any case. Exubera's elimination of the need for silicone instead of going over old ground I want to focus on launch, which I myself once wrote could signal the reduction in piston release force some of the more recent developments.

6 Opening of the floodgates for systemic pulmonary reduction in travel force variation First though, just a few reassuring figures to con- protein and peptide products, and the dawn of a new reduced risk of leachables and extractables firm that there has indeed been no let up in the pre- age of non-invasive drug delivery, has not registered lighter weight filled market's growth since last time we checked! In as the key event it might have been. The lack of a greater potential for adding functional elements his article on page six of this issue, Bernie Lahendro, boom in non-invasive drug delivery has, to some into the syringe manufacturing process Vice-President of Daikyo Crystal Zenith extent, left the way clear for prefilled syringes to go application in a broader range of therapeutic areas Technologies at West Pharmaceutical Services, states from strength to strength. that over the past three years, unit sales of prefilled On page six of this issue, you will find more syringes have risen almost 22% from US$ billion WHERE ARE THE INNOVATIONS TO detailed information about plastic syringes from the to US$ billion.

7 In an April 2007 article in P&MP, BE FOUND? point of view of one commercial supplier, West Patrick Grueninger of Schott forma vitrum said: We Earlier this year, at the Pharmaceutical Technologies Pharmaceutical Services (Lionville, PA, US), which see strong movement to prefilled syringes from vials Arden House Conference in West Point, NY, US, Dr licensed the rights to Daikyo Seiko's (Tokyo, Japan). and ampoules on new and existing products with sus- Donna French, Executive Director of Drug Delivery cyclic polyolefin, branded Crystal Zenith. tainable growth rate between 10-15%. And a recent Engineering at Amgen, made the following two Other suppliers of plastic syringes and/or the study conducted by IMS Health and Becton observations about current developments: polymers suitable for their manufacture include: Dickinson predicted growth at more than 12% per Injection devices are becoming increasingly Zeon Chemicals (Louisville, KY, US), which sup- year in the prefilled syringes market.

8 In 2006, bil- utilised as competitive tools plies its Zeonex cyclo olefin copolymer; Schott lion prefilled syringe units were sold and this, the Technology advancements are overcoming previ- forma vitrum (St Gallen, Switzerland), which manu- study said, would grow to billion units by 2010. ous limitations and conventions. factures TopPac syringes made from Topas, a cyclo Dr French's presentation was on the topic of par- olefin copolymer supplied by Topas Advanced AN INCREASINGLY INTERESTING SECTOR enteral devices generally, but these two points are Polymers (Frankfurt-H chst, Germany); Baxter very much valid for prefilled syringes . The two are BioPharma Solutions (Round Lake, IL, US), which Over the past few years, at the same time as it has also intrinsically linked, as it is often the drive for a manufactures a line of syringes and vials made from become larger and more valuable, the prefilled competitive edge that brings about the technology a copolymer and branded ClearShot; and BD.

9 syringes sector has also become more interesting, advancements we see. (Franklin Lakes, NJ, US), which launched its on various fronts. Sterifill SCF line of syringes in 2004. The latter are We have seen the numbers of pharmaceutical made from BD's proprietary Crystal Clear Polymer. products launched onto the market in prefilled THE ARRIVAL OF PLASTIC. syringe formats growing, and as such the pharma One of the most fundamental changes taking place industry is tending to view these systems, and the INNOVATIVE FILLING TECHNIQUES. right now is that the pharma industry is coming technologies and services associated with them, as round to the idea of prefilled syringes made from Another aspect of prefilled syringes where new market proven . As anyone involved in drug deliv- plastic, rather than glass. This has been on the hori- ideas are being put into practice to improve the end ery technology partnering will know, a proven mar- zon for some time the first polymer syringes , result is the filling process.

10 One could be forgiven ket track record is one of the most important boxes although they were made from polypropylene and for supposing that syringe filling, as long as it is that pharma wants ticked before entering into rela- thus had their pitfalls, became available in the 1990s. conducted safely, is compared with drug discovery tionships with suppliers and partners. As is often the case, pharma companies while or drug delivery R&D, for example quite a rigid The prefillable syringe has gained broad accep- happy to talk about the potential benefits of a new process where it is difficult to think of ways truly to tance in the pharmaceutical industry often as the idea moved slowly to begin with. But now instead innovate, apart from the obvious angles for improve- format of choice for many injectable products. of just talking about plastic syringes , we are seeing ment such as reducing cost or increasing speed.