This article is part of a special feature on injectables that was published in the February issue of PTE Digital, available at http://www.pharmtech.com/ptedigital0211.
More and more, biopharmaceuticals and vaccines are being used for medical treatment and this will be an important driver for parenteral drug delivery because the majority of such treatments can only be delivered via this method. As such, syringes/prefilled syringes will remain important and costeffective drug delivery devices. For singledose medicines, prefilled syringes will also continue to serve as the primary drug recipient within the area of needlebased injection devices because they facilitate patient selfinjection and can include other features for enhanced convenience, such as automated needle insertion, injection of the medicinal product and needle retraction.The rapid growth in biopharmaceuticals, coupled with the increasing need for needlebased injection devices suitable for selfinjection, is also a driver for innovative polymer materials, such as Cyclo Olefin Copolymer and Cyclo Olefin Polymer. These can be used with prefilled syringes and offer advantages over traditional glass syringes in terms of appropriateness for sensitive drugs, as well as accuracy and strength. They also offer more options in the design of the syringe; for instance, integrating functions such as Luer Lock adaptor or adding functions adapted for the specific therapy or target patient population.
Advances in traditional needles
The production of hypodermic needles requires particular core competences for the manufacturing and assembly of stainless steel cannulae. Continuous improvements within a fully automated production process and the use of integrated process control and vision control systems are resulting in high quality, consistent and sharp needles that can help reduce patient trauma.
For enhancing patient comfort, the evolution towards thinner needles continues. Needle gauge sizes of 30 G and smaller are more widely used for intradermal and subcutaneous injections. At the same time, however, the high viscosity of many biologic drugs is posing challenges because they require high forces and are not easy to administer through thin needles. In recent years, innovative needles using tapered cannulae have been brought to the market that are comfortable for patients and, at the same time, improve the flow characteristics for ease of injection. Some other innovations with hypodermic needles relate to the prevention of transmitting infectious diseases via needlestick injuries by integrating passive sharps injury protection features, such as needle encapsulation technologies.
The risks associated with sharps injuries and needlesticks are well recognised, with the European Commission estimating that 1200000 needlestick injuries occur in Europe each year.1 To help create the safest possible working environment in the healthcare sector, the EC introduced the Framework Agreement on the prevention of sharp injuries in the hospital and healthcare sector by adopting Council Directive 2010/32/EU, published in the official European Journal on 10 May 2010.2 EU member states are now required to bring this Directive into law by 11 May 2013. Among other things, the Directive strives to set up an integrated approach in risk assessment, risk prevention, training, information, awareness raising and monitoring.
Manufacturers have also joined the fight against needlestick injuries by developing medical devices that incorporate safetyengineered protection mechanisms. A broad conversion to such safetyengineered devices has already taken place in the US following the adoption of the Needlestick Safety and Prevention Act in November 2000. In time, we may expect the same within the EU because of the national transposition of the EU Council Directive 2010/32/EU.
The future of the traditional syringe
In the future, we may see further improvements in traditional needles and syringes by the offering of a larger variety of needle sizes and specific geometries to accommodate specific therapies, particularly for the treatment of chronic diseases.
Without a doubt, developments in needleless drug delivery, such as patches, will continue to make progress after having proven efficacy and tackled all technological and regulatory hurdles — such technologies will certainly provide more drug delivery options. For the moment, however, current market research predicts further growth in the prefilled syringes market.
William Dierick is Business Development Manager at Terumo.
1. Commission of the European Communities, Proposal for a Council Directive: Implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU (October 2009). http://eur-lex.europa.eu
2. Official Journal of the European Union, Council Directive 2010/32/EU: implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU (10 May 2010). http://eur-lex.europa.eu