Intranasal Nebulizer with Disposable Drug Cartridge for Improved Delivery of Vaccines and Therapeutics


Intranasal delivery is a simple, inexpensive and needle-free route for administration of vaccines and therapeutics. This intranasal delivery technology, developed with Creare LLC., includes low-cost, disposable drug cartridges (DDCs) that mate with a durable hand-held device. The rechargeable-battery-powered device transmits ultrasonic energy to the DDC to aerosolize the drug and is capable of performing for eight hours at 120 vaccinations per hour. Potential applications for this platform technology include intranasal vaccination (e.g. seasonal or pandemic influenza vaccines) and intranasal delivery of locally active (e.g. antihistamines, steroids) or systemically active (e.g. pain medications, sedatives) pharmaceuticals.

The DDCs themselves offer two unique benefits. First, all components that contact the active agent or the patient may be easily disposed of, which reduces the risk of patient cross-contamination and minimizes cleaning and maintenance requirements of the hand-held device. Second, DDCs provide a low-cost and simple method to package and distribute individual doses.

This technology also allows for significant dose-sparing. Preliminary studies have shown robust immune responses when this technology is used to delivery significantly reduced doses of Live Attenuated Influenza Vaccine in animal models. The intranasal nebulizer produces droplets sized for optimum depositioning in the nasal airway. The small nebulizer droplets essentially “spray paint” the internal nasal airway, resulting in an increased tissue surface coverage that may enable a significant dose reduction. In contrast, currently available nasal delivery devices, such as nasal sprays and droppers, do not provide efficient intranasal delivery in humans because the large droplets they generate fail to coat a significant portion of the nasal airway. Large droplets also tend to drip out of the nose or down the throat, which can be unpleasant for the patient in addition to wasting a sizable portion of the active agent.

Potential Commercial Applications: Competitive Advantages:
  • Intranasal delivery of vaccines and therapeutics
  • Childhood vaccination programs, mass immunization campaigns, or response to epidemics
 
  • Safe, needle-less delivery
  • No patient-to-patient contamination
  • Long-life, rechargeable battery
  • Consistent delivery and dose-sparing
  • Nasal delivery of live-attenuated vaccines may be more effective than traditional injected vaccines
  • Cost-effective
  • Reduces biohazard waste
  • May be administered by personnel with minimal medical training
  • Easy means of delivery to children with fear of needles


Development Stage:
  • Prototype
  • In vitro data available
  • In vivo data available (animal)


Inventors:

Mark Papania (CDC)  ➽ more inventions...

James Barry

Mark Bagley

Eric Friets

Darin Knaus

Nabil Elkouh

Robert Trabka

James Norris


Intellectual Property:
U.S. Pat: 7,225,807 issued 2007-06-05
U.S. Pat: 8,544,462 issued 2013-10-01
U.S. Pat: 7,954,486 issued 2011-06-07
U.S. Pat: 8,656,908 issued 2014-02-25
U.S. Pat: 9,492,068 issued 2016-11-15
US Application No. 10/471,620
US Application No. 11/796,313
US Application No. 60/559,318
PCT Application No. PCT/US2005/011086
US Application No. 10/587,814
US Application No. 13/099,261
US Application No. 61/351,745
PCT Application No. PCT/US2011/039020
US Application No. 13/701,992
PCT Application No. PCT/US2014/032863
Various international issued and pending patents

Publications:
Smith JH, et al. PMID 22075083

Licensing Contact:
Karen Surabian, J.D., M.B.A.
Email: karen.surabian@nih.gov
Phone: 301-594-9719

OTT Reference No: E-308-2013-0
Updated: Jun 14, 2018