PREFILLED SYRINGES - ONdrugDelivery Magazine

1 PREFILLED SYRINGESINNOVATIONS THAT MEET THE GROWING 2005 ONdrugDelivery Ltd PREFILLED SYRINGES : innovationsthat meet the growing demand This is the first in a series of sponsored themedpublications from ONdrugDelivery Ltd. Eachissue will focus on a specific topic within the fieldof drug delivery, and contain up to eight articlescontributed by industry contact information appears alongside eacharticle. Contributing companies would be delight-ed to hear from interested readers would also be very pleased topass on to authors, or answer as appropriate,any queries you might have in relation to this publication or others in the :Guy Furness, Managing DirectorT: +44 1273 831 370E: PREFILLED SYRINGES : innovations that meet thegrowing demand.

2 Published by ONdrugDeliveryLtd, Cedar Cottage, Newtimber Place Lane,Newtimber, West Sussex, BN6 9BU, UnitedKingdom. Registered in England: No 2005 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 publishermakes 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. * except the article: Outsourcing as a strategic decision Vetter Pharma-FertigungFront cover photograph reproduced with permission from Buender Glas GmbHIntroductory commentGeorg Roessling (Schering AG / PDA)3 Sterile PREFILLED SYRINGES .

3 Market dynamics & current issues in manufacturing & controlKarim Abdelkader, Ryan M Akers, and Michael J Akers (Baxter Healthcare)4-5 Prefillable SYRINGES trends and growth strategiesGlenn A Thorpe (BD Medical)6-8 Why new developments are important in injectable delivery todayMathias Romacker (Buender Glas)9-11 The next generation of safety prefill devices: NMT s Safety Prefill Needle Unit enters the commercial Littleton (NMT Group)12-13 Outsourcing as a strategic decisionMax Horn (Vetter Pharma-Fertigung)14-16 The intricacies of selecting and evaluating plungers for PREFILLED syringe systemsFrances DeGrazio (West Pharmaceutical Services)17-19 New-generation auto-injectors: taking self injection beyond PREFILLED syringesIan Thompson (Ypsomed)21-24 Company profilesThe Medical HouseImprint Pharmaceuticals25 CONTENTSThe use of PREFILLED SYRINGES is a modernway to apply parenteral drugs.

4 With theachievements in science and technology inthe past twenty years an increasing numberof injectables apply PREFILLED SYRINGES . Thebenefits compared with vial-disposablesyringe concepts are obviously conve-nience and ease of handling as well as advantages in safety and a reduction of drug currently existing market of pre-filled SYRINGES is in the range of US$1-2billion. The growth rate is to be expectedto remain at a high level of more than10% the future, the pharmaceutical andbiotech industries will ask for prefillabledrug delivery systems for valuable potentdrugs.

5 Particularly, for biologicals the par-enteral application will remain the mostimportant route of valuable new drugs will needapplication systems that allow for accuratedosing and safe handling. There will be anincreased use of drugs in home-care situa-tions, which will result in a need for pre-filled SYRINGES , given the inherent benefits inconvenience and safe handling. In this publication you will find a compi-lation of papers that cover a broad range oftopics on PREFILLED SYRINGES . Descriptions ofthe basic components of PREFILLED syringeslike glass, needle and stoppers are given andspecial aspects of quality are addressed.

6 Inaddition, handling and safety issues as wellas auto-injector features are described. Onearticle deals with manufacturing and out-sourcing papers are written by experts in thefield, giving an insight into the capabilitiesand services of their , this compilation of papers is not covering every aspect of the field of pre-filled SYRINGES , but aims to provide the read-er with a better understanding of thisdynamically growing field of parenteralapplication idea to create such a brochure wasborn at the October 2004 PDA meeting: The Universe of PREFILLED SYRINGES , inHanover, Germany.

7 The next PDA meetingon PREFILLED SYRINGES will take place inMunich, Germany, on October 17-18,2005. For details please visit the website, , or contact Gautam Roessling, PhDSchering AGBoard Member of PDA3 Copyright 2005 ONdrugDelivery DYNAMICS The worldwide prefill market is estimated tobe one billion units 1. PREFILLED SYRINGES in theUS market have been growing at a rate of 20%per year for at least five years 2. Studies indicatethat the majority of healthcare professionals aredemanding the convenience and safety that pre-filled SYRINGES provide 1.

8 In addition, conversions into a prefilledsyringe system (from a vial) and/or supplement-ing lyophilised drugs in a vial with a prefilleddiluent syringe are becoming more and moreapparent in antithrombotics, vaccines, anti-infectives, and other biotech drugs indicated forchronic conditions such as rheumatoid arthritis,multiple sclerosis, psoriasis and Crohn s dis-ease. Growth in these conversions to prefilledsyringes (and newly approved products in pre-filled SYRINGES ) is expected to primary driving factors behind thegrowth of PREFILLED SYRINGES include: ease of administration; more convenient forhealthcare professionals and end users; easierfor home use; easier in emergency situations reduction of medication errors, misidentifica-tion.

9 Better dose accuracy increased assurance of sterility better use of controlled drugs such as narcotics lower injection costs less preparation, fewermaterials, easy storage and disposal elimination of vial overfill for products trans-ferred to SYRINGES for direct injection or addi-tion to primary diluents removal of preservatives ( thimerosol) fromvaccine formulations product differentiation Most lyophilised drug products are filledinto vials. While options such as dual- cham-bered delivery systems are on the market andcontinue to be created,such devices are notcompatible with manylyophilised proteindrugs because ofincreased siliconeexposure when the rub-ber separator is activated to mix diluent withpowder.

10 For silicone-sensitive proteins, the pro-tein product lyophilised in the vial and the pre-filled diluent syringe is a best option to assurelong-term and reconstituted protein stability. At Baxter BioPharma Solutions, our offeringfor PREFILLED diluent SYRINGES has been have streamlined the approach to process4 STERILE PREFILLED SYRINGES : MARKET DYNAMICS AND CURRENT ISSUES INMANUFACTURING AND QUALITY CONTROLWith the potential for filling up to 300 million SYRINGES annually at its facility in Bloomington,Indiana, US, Baxter BioPharma Solutions is the leading parenteral contract manufacturer ofprefilled SYRINGES in North America.