Information & Studies

Just draw the dose into the ampoule. Load the ampoule into the injector. Press the trigger. Gentle, safe and just as effective as a needle injection. Say goodbye to needles.

Diabetes Mellitus

Insulin Study TR-105
This in-vitro study demonstrates complete retention of molecular identity of insulin molecules injected via the INJEX.

Insulin Study TR-006
This data suggests that there is little or no difference in the pharmacokinetics of a fast acting insulin when injected with either the INJEX Injector or the syringe.

Dynamic control of needle-free jet injection
Stachowiak JC, Li TH, Arora A, Mitragotri S, Fletcher DA. 2009 Apr 17;135(2):104-12. Epub 2009 Jan 21.

Human Insulin Analog – induced Lipoatrophy
Ximena Lopez, MD., M. Casells, MD.

Jet-injected insulin in associated with decreased antibody production and postprandial glucose variability when compared with needle-injected insulin in gestational diabetic women.
Jovanovic-Peterson L, Sparks S. Palmer JP, Peterson CM. Sansum Medical Research Foundation, Santa Barbara CA 93105

Needle-free injection-science fiction or comeback of an almost forgotten drug delivery system?

Abstract

The first to create a “needle-free injector” was the American anesthetist Robert A. Hingson, 65 years ago. Since that time those devices underwent a changing history. In 1986 an outbreak of hepatitis B among patients receiving injections from a needle-free multiple-use-nozzle injector was documented and related to the use of the injector device. Due to such risk of transmission of infection with these reusable devices, their application has been restricted. In 1998 the WHO recommended that only conventional needles and syringes should be used for immunization until safe needle-free injectors were identified through independent safety testing. Since needle-free injection has shown numerous advantages in comparison to conventional injection, new systems were developed that combine the advantages of needle-free injection with sufficient safety in mass vaccination programs. As an alternative to this early injector type, the disposable-cartridge injectors were developed. The newest research field in the area of the needle-free injection systems opened with the development of powder injectors, in which the drug preparation is no longer a suspension or solution, but a powdered solid. This injector type using powder formulations shows a number of advantages in comparison with the conventional needle/syringe injection technique as well as towards the liquid jet injectors. Due to this new kind of injector, the comeback of the needle-free injection technique in large-scale vaccination programs of the WHO seems reasonable and within reach.

PMID: 17879809 [PubMed - indexed for MEDLINE]

104(11):4255-60. Epub 2007 Mar 6.

Needle-free delivery of macromolecules across the skin by nanoliter-volume pulsed microjets.

Biomolecular Science and Engineering, University of California, Santa Barbara, CA 93106, USA.

Abstract

Needle-free liquid jet injectors were invented more than 50 years ago for the delivery of proteins and vaccines. Despite their long history, needle-free liquid jet injectors are not commonly used as a result of frequent pain and bruising. We hypothesized that pain and bruising originate from the deep penetration of the jets and can potentially be addressed by minimizing the penetration depth of jets into the skin. However, current jet injectors are not designed to maintain shallow dermal penetration depths. Using a new strategy of jet injection, pulsed microjets, we report on delivery of protein drugs into the skin without deep penetration. The high velocity (v >100 m/s) of microjets allows their entry into the skin, whereas the small jet diameters (50-100 mum) and extremely small volumes (2-15 nanoliters) limit the penetration depth ( approximately 200 mum). In vitro experiments confirmed quantitative delivery of molecules into human skin and in vivo experiments with rats confirmed the ability of pulsed microjets to deliver therapeutic doses of insulin across the skin. Pulsed microjet injectors could be used to deliver drugs for local as well as systemic applications without using needles.

PMID: 17360511 [PubMed - indexed for MEDLINE]PMCID: PMC1838589

3(5):565-74.

Needle-free liquid jet injections: mechanisms and applications.

Unilever Research and Development, 40 Merritt Blvd., Trumbull, CT 06611, Abstract

Liquid jet injections employ a high-speed jet to puncture the skin and deliver drugs without the use of a needle. They have been used to deliver a number of macromolecules including vaccines and insulin, as well as small molecules, such as anesthetics and antibiotics. This article reviews liquid jet injectors with respect to their historical perspective, clinical applications, mechanisms and future prospects. An overview of the use of jet injectors for delivery of vaccines, insulin and growth hormones is presented. Particular attention is paid to the mechanistic understanding of jet injections, especially the dependence of jet penetration on parameters such as nozzle diameter, velocity and jet power. Finally, gaps in the current understanding are presented and suggestions for future research and development are made.

PMID: 17064242 [PubMed - indexed for MEDLINE]

150(3):455-61.

Assessment of the biological performance of the needle-free injector INJEX using the isolated porcine forelimb.

Vitro-Tec Entwicklungs-GmbH, Wiesenweg 10, D-12247 Berlin, Germany. wagner@vitro-tec.de

Abstract

BACKGROUND: The development and utilization of novel needle-free injection devices in order to minimize needle stick injuries make increasing demands for suitable assay systems, which reflect the physiological situation in humans as close as possible.

OBJECTIVES: It was therefore the goal of the present study to test the biological performance of a needle-free injector (INJEX) by the use of porcine skin as a model with a high predictive value for the feasibility in humans because of its close similarity to human skin.

METHODS: In order to use porcine skin in the context of the underlying tissues, the isolated porcine forelimb was chosen as an assay model for use with the INJEX injector. Ink or the fluorescent dye fluorescein-isothiocyanate was injected and the penetration depth was determined metrically and dye distribution histologically. To assess the resorption of heparin, needle injection was compared with needle-free injection in a perfused limb model.

RESULTS: Increasing amounts of ink increasingly penetrated into subcutaneous tissue layers in a cone-shaped manner mainly following lead structures. Penetration was hampered by skin thickness and by the deep muscle fascia, which served as a penetration barrier. Resorption of heparin was similar irrespective of injection by the use of a needle or the INJEX device.

CONCLUSIONS: The isolated porcine forelimb serves as a versatile tool for the assessment of the biological performance of needle-free injection devices such as INJEX. Further studies are necessary to correlate the model for drug delivery in humans.

PMID: 15030327 [PubMed – indexed for MEDLINE

Nov. 2002 Pharmacokinetics and Glucodynamics of Rapid-, Short-, and Intermediate-Acting Insulins: Comparison of Jet Injection to Needle Syringe, Mark J. Sarno, B.A. Vision Biotechnology Consulting Encinitas, CA Jo Bell, R.N. Steven V. Edelman, M.D. University of California at San Diego School of Medicine and Veterans Affairs Medical Center San Diego, CA. Nov. 2002

Dec 2001 Present and future of insulin therapy in type 2 diabetic patients

Delivery of insulin by jet injection: recent observations, Bremseth et al., Diabetes Technol Ther (2001), 3-2: 225-32

March 2001 Comparison of blood sugar and insulin kinetics following needle-free and Pen injection of Insulin M. Pfohl, Poster: 36th Annual Conference of the German Diabetes Association

Feb 2001 Retention of structural/potency characteristics of Lantus Insulin, AKA Insulin Glargine, or HOE901 ANALYTICAL INVESTIGATIONAL STUDY TECHNICAL REPORT TR-01-001 # EQUA-004, Mark Sarno Vision Biotechnology Consulting February 9, 2001

Dec 2000 New trend in therapy of Diabetes: More freedom, fewer risks comfortable insulin administration, Harsch et al., MMW Fortschritte der Medizin(2000) 142-28/9:24-6

June 2000 Clinical Experiences with needle-free Application(Jet-Injection) of Insulin and other Pharmaceuticals to be injected subcutaneously M. Pfohl, Ruhr Universität Bochum Juni 2000, Präsentation 35. Jährliche Diabetiker Treffen Deutschland

EQUIDYNE SYSTEMS, INC. “TECHNICAL REPORT TR-105Retention of structural/potency characteristics of Insulins Authored by: Mark Sarno,Vision Biotechnology Consulting

EQUIDYNE SYSTEMS, INC. TECHNISCHER REPORT # 006 Rev. #7/8/99 INJEX SYSTEM: Wirksamkeitsstudie Insulin

Retention of structural/Potency characteristics of injectable drugs and model compounds, Mark Sarno Project D Investigational Protocol #Equa-001 12.1998

Subcutaneous or intramuscular injections of Insulin in children: Are we injecting where we think we are?, Polak et al., Diabetes Care (1996) 19-21: 1434-35

Human insulin-induced lipoatrophy. Successful treatment using a jet-injection device. S Logwin, I Conget, M Jansa, M Vidal, C Nicolau and R Gomis, Diabetes Care March 1996 vol. 19 no. 3 255-256

Jet-injected is Associated Decreased Atibody Production and Postprandial Glucose Varability with needle-Injected Insulin in Gestational Diabetic Women, Jovanovic-Peterson, L. Sparks,

A survey of patient perference for Insulin jet injectors vs. needle and syringe , Denne et al., Diabetes educ (1992) 18-3: 223-7

Comparison of Insuline levels (Humulin U-100): After injection by Jet-stream and disposable Insulin syringe , Malone et al., Diabetes Care (1986) 9-6: 637-41

Twice daily mixed regular and NPH Insulin injections with the new Jet Injector versus conventional syringes: Pharmacokinetics of insulin absorption, Halle et al., Diabetes Care (1986) 9:279-82

Comparision of Plasma Insulin profiles after subcutaneous administration of Insulin (Actrapid U-100) Jet spray and conventional needle injection in patients with Insulin-dependent Diabetes mellitus, Pheling et al., Mayo Clin Proc (1984) 59: 751-54

Comparison of insulin levels after injection by jet stream and disposable insulin syringe. J I Malone, S Lowitt, N P Grove and S C Shah. Diabetes Care November 1986 vol. 9 no. 6 637-640

Plasma free Insuline profiles after administration of Insuline by jet and syringen injection, Taylor er al., Diabetes Care (1981) 4:377-9

Injex Media for Diabetes

A selection of videos showing Injex being used gently, safely and just as effectively as a needle injection around the world.

Through the skin in a fraction of a second with no needles, and less pain.Purchase Injex online today to be free of needles.