Needle-free injection system

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

Cooper, J.A. Bromley, L.M. Baranowski, A.P. Barker, S.G.E. Evaluation of a needle-free injection system for local anaesthesia prior to venous cannulation. Anaesthesia 2000, 55, 247-250. 

Jackson, J. Dworkin, R. Tsai, T. McMullen, R. Kuchmak, N. Comparison of antibody response and patient tolerance of yellow fever vaccine administered by the Biojector needle-free injection system versus conventional needle/syringe injection. International Society of Travel Medicine Conference, Paris, 1993. 

FIGURE 26.5 (See color insert following page 40). Cnrrent and future trends in delivery systems for mAbs inclnde (a) dual-chamber cartridge and prefilled syringe with attached needle (conrtesy Vetter), (b) pen systems for self-administration, and (c, d) needle-free injection systems (BioJect). 

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. 

Szmuk P, Szmuk E, Ezri T (2005) Use of needle-free injection systems to alleviate needle phobia and pain at injection. Expert Rev Pharmacoecon Outcomes Res 5(4) 467 77... 

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. 

A number of DNA vaccines have progressed into clinical trials for the prevention and/or treatment of HIV, malaria, cytomegalovirus (CMV) and hepatitis B and C [23,24], So far the DNA vaccines have been well tolerated in clinical trials [23] and have produced both humoral and cellular responses in some trials [41], but overall the potency has been disappointing [20], Although DNA is typically injected intramuscularly, alternative delivery systems have been evaluated. One such system that has been tested clinically for hepatitis B involves coating plasmid DNA onto gold beads, which are then propelled into the epidermis using a needle-free delivery system [20,42,43],... 

The key to achieving a successful injection with a needle-free system is to understand the necessary mechanics for the consistent penetration of skin and fat with a liquid jet, without causing unnecessary trauma to the tissues and to the molecule being delivered. Only recently have detailed studies of the fluid mechanics of needle-free injection appeared. The fluid mechanics conditions necessary for a consistent targeted needle-free injection are addressed in the following section. 

Needle-Free Drug Delivery Systems. The three types of needle-free drug delivery systems are liquid, powder, and depot injections. Each of these types uses some form of mechanical compression to create enough pressure to force the medication into the skin. Although these needle-free delivery systems cost more initially and require more technical expertise... 

Fig. 4 Summary of preference between needle-free delivery (Intraject , Aradigm Corporation) and needle-based delivery (courtesy of Aradigm Corporation). Volunteers were asked which system they would prefer if they had to self-inject regularly at home.

Lysakowski, C. Dumont, L. Tramer, M.R. Tassonyi, E. A needle-free jet-injection system with lidocaine for peripheral intravenous cannula insertion a randomized controlled trial with cost-effectiveness analysis. Anesth. Analg. 2003, 96, 215-219. 

Lidocaine is absorbed rapidly after parenteral administration and from the gastrointestinal and respiratory tracts. Although it is effective when used without any vasoconstrictor, epinephrine decreases the rate of absorption, such that the toxicity is decreased and the duration of action usually is prolonged. In addition to preparations for injection, an iontophoretic, needle-free drug-delivery system for a solution of lidocaine and epinephrine (lontocaine) is available. This system generally is nsed for dermal procedures and provides anesthesia to a depth of np to 10 mm. 

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. 

Cauda equina syndrome occurred in a 55-year-old woman who underwent spinal anesthesia with a 22 G needle in the L4-5 interspace (214). On needle insertion, she felt radiating pain in her right leg. The needle was immediately withdrawn and repositioned. Pain-free intrathecal injection of 2.0 ml of hyperbaric cinchocaine 0.24% with adrenaline 66 micrograms resulted in block to LI. Surgery was carried out in the supine position. Three days postoperatively, she had enuresis and reduced perineal sensation, without bowel dysfunction or lower limb symptoms. There was sensory loss at S2-5. The symptoms persisted, required self-catheterization and systemic steroids, and disappeared on the 19th postoperative day. 

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