Needle-free device

Needle-free companies Cross-Ject and BioValve employ chemical reactions to generate gas at a predictable and apparently reproducible rate to power single-use needle-free devices. A mixture of chemicals is mechanically or electrically ignited to initiate a reaction where the chemical burns and produces gas. The composition of the chemicals can be varied... 

Patient acceptability is another area that has seen significant developments in the last 10 years. Early needle-free devices were somewhat rudimentary in design and often used far more force to deliver the drug than was necessary. In addition to affecting pharmacokinetics, the excess force also led to a perception that needle-free injections are uncomfortable and inconvenient. Interestingly, despite various side effects and frequently poor performance (10-20% unsuccessful injections), needle-free presentations were still generally preferred by patients, although only around 70-85% preference was typically seen. " ... 

Needle-free devices have demonstrated consistent delivery to the epidermis, the dermis, the subcutaneous layer, and the intramuscular space. While questions remain over the ability of this technology to target the dermis or the muscle across a very wide range of subject morphologies, published data suggest that the delivery is at least as good as that achieved with a needle which remains the gold standard for all parenteral injections. 

Partsch, C.-J. von Bilren, E. Kiihn, B. Sippell, W.G. Brinkmann, G. Visualization of injection depot after subcutaneous administration by syringe and needle-free device (Medi-Jector) first results with magnetic resonance imaging. Eur. J. Pediatr. 1997, 156, 893-898. 

Some aspects of insulin were dealt with in section 9.4.4. Table 11.8 lists some of the insulin formulations designed to produce different durations of onset and action. Insulin is generally self-administered subcutaneously with injection pens, needle-free devices or pumps. 

Using injection vials and needle-free devices, as far as possible, to minimise needle-stick injuries. If sharps cannot be avoided, their use should be minimised [18], see also Sect. 26.10... 

Other delivery systems are transdermal patches, metered dose inhalers, nasal sprays, implantable devices, and needle-free injections. A description of needleless injection is given in Exhibit 5.16. 

The use of needle-free jet devices for the delivery of nucleic acids has been described for various disease models, and has been found to generally enhance DNA uptake in various tissues and to increase DNA vaccine efficacy. Jet injection has been found to be an efficient method to induce papillomas in rabbits by inoculation with cottontail rabbit papillomavirus DNA (Brandsma et al., 1991). Jet injection has been used to introduce DNA through the skin surface, effectively transfecting skin, muscle, fat and mammary tumor tissue (Furth et al., 1992). 

Powder injection applies many of the principles of pulmonary delivery of dry powders to the lungs The drug has to be in the form of very small particles, is dispensed from a reservoir, and is delivered as an aerosol i.e., particles are dispersed in a gas. Liquid or dissolved drug can be delivered by precipitation or adsorption onto carrier particles. The big difference with pulmonary delivery is the momentum at which the particles are delivered. Driven by a high-pressure helium gas stream, the particles travel fast enough to penetrate the outer layer of the skin, the stratum corneum. The design of devices to deliver needle-free injection of solids was pioneered by researchers at the University of Oxford who founded PowderJect Pharmaceuticals PLC in 1993 (now PowderMed Ltd.) to develop the only powder-based technology so far. Since that... 

A drug product can only be successful if it is delivered in a timely manner to the site of action in a way that will be amenable to the patient and in a way to ensure product quality. Different routes of administration may be used to achieve either systemic or local delivery of the protein. Devices such as needle-free injectors and nebulizers may be used to deliver the protein and to enhance patient compliance with use of the drug. Both the route of administration and the decision to use a device are optimally determined early in clinical development of the protein so that there is plenty of clinical experience with the final product. Some... 

Selection of the appropriate route of administration and delivery device is critical for the commercial success of a drug product. Although injections are the most efficient delivery method for proteins, they are not always the most suitable from the patient s perspective. Few routes of administration (IV, IM, SC, pulmonary, and topical for local delivery) have been successful to date with protein therapeutics because of the size and complexity of the protein structure. Consideration of the bioavailability via a given route must be made when determining the dose required. Use of a delivery device such as an implantable pump, needle-free injector, or dry-powder inhaler may yield a product with a commercial advantage over a competitor s product. 

Fig. 2 The Intraject device. A prefilled, disposable, needle-free injector. (Courtesy of Aradigm Corporation, Hayward, California, U.S.A.)...

Algorx has the rights to develop the PowderJect needle-free injection technology in all areas outside of DNA vaccines. The device is helium powered and was described more fully earlier in this chapter. 

Potter, C. Caretek medical device. Management Forum Conference on Needle-Free Injection Systems and Auto-Injectors. Management Forum, London, England, Feb 23, 2004. 

Cui, Z. Baizer, L. Mumper, R.J. Intradermal immunization with novel plasmid DNA-coated nanoparticles via a needle-free injection device. J. Biotechnol. 2003, 102, 105-115. 

There are different devices conunerciaUy available for needle-free injectirai. Commonly jet injectors produce a high-velocity jet of medicine that penetrate the skin. Medicines and vaccines can be administered either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet that penetrates the skin. The gas-forced needle-free injection systems are typically made up of three components including an injection device, a disposable needle free syringe and a gas cartridge. 

The hi-dose delivery system for our intransal ketamine product candidate provides non-invasive (i.e. needle-free) administration compared to IV or IM injections, via a rugged, simple to use device that can be patient-administered if necessary. Each disposable device delivers a total of 30 mg ketamine with well-characterized, predictable pharmacokinetics. This approach to delivering subanesthetic doses of ketamine may be particularly advantageous in emergency situations where convenience, speed of drug delivery/onset, and avoidance of accidental needle sticks in healthcare providers are desirable. In addition, our intranasal ketamine product candidate was formulated to minimize neurotoxicity, a question that has been raised regarding the differently formulated ketamine product currently approved for anesthesia. 

The recently introduced closed Luer-Lok access devices , sometimes called needle-free connectors may significantly reduce CVC bloodstream infections due to less manipulation with the ports. When there are no extracorporeal bloodlines connected to the CVC, the silicone seal automatically closes entry into it. With connection of the lines, a straight internal fluid path is created. Those devices make use of anticoagulant lock unnecessary and can thus be used in patients with heparin-induced thrombocytopenia. However, pressure drop over some types may decrease the blood flow obtainable from the CVC [25]. 

---