Technology Bundle ID: TAB-2673

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

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Licensing Contact:
Primary Inventors: 
Mark Papania (CDC)
Co-Inventors: 
Darin Knaus (Creare LLC), Eric Friets (Creare LLC), James Barry (Creare LLC), James Norris (Creare LLC), Mark Bagley (Creare LLC), Nabil Elkouh (Creare LLC), Robert Trabka (Creare LLC)
Development Stage: 
Prototype
Development Status: 
  • Prototype
  • In vitro data available
  • In vivo data available (animal)
Institute or Center: 
CDC

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.

Applications:
  • Intranasal delivery of vaccines and therapeutics
  • Childhood vaccination programs, mass immunization campaigns, or response to epidemics
Advantages:
  • 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

Patents

PCT Application PCT/US2002/007973
Filed on 2002-03-13
PCT Application PCT/US2005/011086
Filed on 2005-04-01
PCT Application PCT/US2011/039020
Filed on 2011-06-03
PCT Application PCT/US2014/032863
Filed on 2014-04-03
US Application 15/288,979
Filed on 2016-10-07
US Application 16/798,127
Filed on 2020-02-21
US Application 60/276,539
Filed on 2001-03-15
US Application 60/559,318
Filed on 2004-04-02
US Application 61/351,745
Filed on 2010-06-04
US Application 61/808,547
Filed on 2013-04-04
US Pat 10,596,334

Issued 2020-03-24
US Pat 7,225,807

Issued 2007-06-05
US Pat 7,954,486

Issued 2011-06-07
US Pat 8,544,462

Issued 2013-10-01
US Pat 8,656,908

Issued 2014-02-25
US Pat 9,492,068

Issued 2016-11-15

Various international issued and pending patents

Publications

Smith JH, et al.
PMID 22075083

Updated

Nov 19, 2013

Data Source: 
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