Over 16 Billion injections (480 Million in immunizations) are administered every year. However, injecting freeze-dried drugs and vaccines is very demanding as it generally involves:

1. Trained personnel take from the refrigerator a sterile vial with the drug or vaccine
2. Take a vial of sterile water for injection from its box
3. Remove a wide-bore needle from its sterile packaging
4.  Attach the needle to the syringe
5.  Use the syringe and needle to aspirate a precise volume of sterile water
6.  Use the syringe and needle to deliver the correct volume of water into the drug containing vial
7.  Swirl or shake the vial until the dried drug is completely dissolved
8.  Use the syringe and needle to aspirate the correct dose back into the syringe
9.  Remove a narrow bore needle from its sterile packaging
10. Replace the wide bore preparation needle with the fresh narrow bore needle for injection
11. Carefully expel all the air
12. Inject the drug or vaccine
13. Safely dispose of the syringe and needle to avoid reuse
14. Schedule next visit for booster dose !

In the Developing World this can represent a significant problem:

• Worldwide, 40% (70% in some countries) of injections are given with reused unsterilized needles,
• Unsafe injections transmit hepatitis B and C, and HIV causing estimated 1.3 M early deaths and an annual burden of $ 535 M in direct medical costs,
• Vaccination programs cannot afford the $200 M /year cost of the “cold chain”,
• It is estimated that over 50% of vaccines go to waste,
• Defficient immunity resulting from non-compliance for booster doses.

In the First World improved drug and vaccine delivery can also have a direct application for established and upcoming vaccines against cervical cancer, seasonal flu, epidemic flu, etc.

AzureBio is developing drug delivery devices that avoid the problems currently associated with current syringes and needles by means of incorporating an injectable drug-containing needles in simple autodisable devices.

The devices meet the requirements for XXI century delivery of drugs and vaccines as they:

a) avoid refrigeration,
b) avoid reconstitution,
b) permit preloaded devices,
c) permit self-administration,
d) are disposable,
e) do not incorporate hypodermic needles.

Key References:

• WHO Fact sheet N°231 – Oct. 2006
• M.A. Miller & E. Pisani 1999. The cost of unsafe injections: Bulletin of the WHO 77(10): 808-811.
• Kane A. et al. 1999. Unsafe injections in the developing world and transmission of blood-borne pathogens: a review. Bulletin of the WHO 77: 789-800.
• Jodar L. et al. 1998. Revolutionizing Immunizations Gen. Eng. News. 18: 6
• JG. Hamilton 1995. Needle Phobia: A Neglected Diagnosis The J.of Family Practice. 41(2)pp. 169-175.