Prefilled Syringes, p. 40 - Safety Syringes, Inc.

Drug DeliveryThe Ins and Outs ofPrefilled Syringesby Jenevieve Blair PolinContributing EditorPharmaceutical companies are realizing the benefits of prefilled syringesand are exploring their use for a variety of drug products.Within months, thenumber-one-selling lowmolecular-weightheparin in the world,Lovenox (enoxaparinsodium injection), will be available inprefilled syringes equipped with aneedle-safety device and a sharperneedle. Gerhard Mayer, PhD, is directorof marketing and business developmentfor Becton DickinsonPharmaceutical Systems (BD; FranklinLakes, NJ), which supplies the prefillableBD Hypak syringes and the safetydevice to the drug’s manufacturer,Aventis (Bridgewater, NJ), and manufacturesmost of the prefillablesyringes used worldwide. He says thislaunch is just the tip of the iceberg forprefilled syringes. He and the otherexperts interviewed for this articleagree that the U.S. market for prefilledsyringes has been growing at a rate ofabout 20% a year for at least 5 years.PREFILLED SYRINGESVERSUS VIALSPrefilled syringes offer severaladvantages over traditional packagingin vials.Ease of use. Use of a prefilledsyringe eliminates several steps thatare required before use of a drug in avial. If the drug is lyophilized, one ofthese steps is reconstitution.Elimination of dosing errors.Prefilled syringes contain the exactdeliverable dose desired. Pharmaceuticalmanufacturers overfill vials by upto 25%, especially if the desired doseis very small, to ensure that the usermay withdraw the desired dose. Thisoverfill of vials allows the possibility ofdosing errors that are eliminated withprefilled syringes.Increased drug supply andreduced waste. Elimination of theneed to overfill reduces waste of product.This is a godsend for manufacturersof product that is in short supply,such as some vaccines. This is also truefor product that is extremely costly tomanufacture, such as biotech drugs.PRODUCTS IN PREFILLEDSYRINGESPrefilled syringes accommodate volumesthat typically range from 0.25 to5.0 ml. They are therefore best suitedto products administered by subcutaneousor intramuscular injection.Three categories account for the bulkof prefilled syringes: antithrombotics,vaccines, and biotech drugs.Antithrombotics. Lovenoxbelongs to the class of drugs known asantithrombotics, which account forabout 40% of all prefilled syringesavailable globally, estimates ErikMiller, director of marketing for SafetySyringes Inc. (SSI; Carlsbad, CA).This class also includes Arixtra(Organon Sanofi-Synthelabo, WestOrange, NJ), and Fragmin (PharmaciaCorp., Kalamazoo, MI). Vetter Pharma-Fertigung(Ravensburg, Germany)fills the Fragmin prefilled syringes,which are supplied integrated with theUltraSafe Passive Delivery Systemmanufactured by SSI.Vaccines. Vaccines are alsoincreasingly marketed in prefilledsyringes. While elimination of overfillis one factor driving the switch to theprefilled syringe, another is theremoval of preservative thimerosolfrom vaccine formulations. With theremoval of the preservative, says BD’sMayer, “a move from a 10- or 15-dosevial to a single-dose prefilled syringemakes a lot of sense.”Home-use products. Home useis also contributing to the growth inthis market sector. “I would say homeuse is growing faster just because thereare some terrific new therapies,” saysMayer. Many drugs for long-termtreatment of chronic disorders,including treatments for rheumatoidarthritis and growth hormones, aregood candidates for self-injection.Ease of use is paramount for productsdesigned for patient administration.One such drug is Copaxone, a treatmentfor multiple sclerosis marketed byIMAGE COURTESY SAFETY SYRINGES INC.