The Next Generation of Vaccines

unimportant decoration Nano-scale droplet illustration

NanoBio™ Topical Applications

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BlueWillow’s NanoBio™ technology platform uses other proprietary nano-scale formulations to enable numerous topical anti-infective products.  The technology employs high-energy, oil-in-water nanoemulsions (NE).  As shown below, the resulting products are composed of droplets 200-600nm in size that use a physical process to disrupt the outer lipid membrane of viruses, bacteria and fungi:

The droplets traverse the pores and hair follicles of the skin and mucosal membranes, without disrupting normal tissues. These droplets permeate to the epidermis and dermis where they interact with and disrupt organisms at the site of an infection.

NanoBio Protect logo

In 2018, BlueWillow completed testing of its new NanoBioTM Protect formulation, which offers several unique advantages for the topical treatment of infections:

  • Formulated to enable near-term launch as an OTC skin antiseptic
  • Comprised of soft, biodegradable nanodroplets that effectively permeate skin to the site of infection
  • Active against bacteria, viruses and fungi
  • Prevents wound progression by attenuating inflammatory cytokines
  • Goes on like a lotion and hydrates skin following use
  • Shown to be safe in extensive preclinical and clinical testing
  • Demonstrated stability of 3 years
  • Manufacturing scaled to commercial levels
  • Able to incorporate, deliver and enhance other active agents
  • Patent coverage through 2029 (issued), 2039 (pending)

When tested in standard in vitro models, NanoBio Protect completely killed all gram-positive and gram-negative bacteria within 60 seconds of exposure, as shown below:

 

Graph of Nanobio Protect effectiveness

Ex vivo tests in human skin demonstrate that NanoBio Protect permeates up to 7x better than commercial products or aqueous solutions containing the same monograph antiseptic active ingredient.  Since most viruses, bacteria and fungi reside in the epidermis and dermis, enhanced permeation is critical to improved efficacy:

Graph of levels of BZK in skin following application

Finally, extensive in vivo studies in mice1, rats2 and pigs have demonstrated that NanoBio Protect is effective as a broad-spectrum antimicrobial therapy.  In addition, burn wound progression studies in rats3 and pigs have demonstrated that the product also minimizes pain and prevents burn progression by reducing:

  • Dermal pro-inflammatory cytokines, including IL-1b, IL-6 and IL-8;
  • Neutrophil sequestration into the wound; and,
  • Hair follicle cell apoptosis.

References:

1 – “Screening of Nanoemulsion Formulations and Identification of NB-201 as an Effective Topical Antimicrobial for Staphylococcus aureus in a Mouse Model of Infected Wounds”. Military Medicine. 2016, May: 181, 5S:259-264

2 – “Topical Nanoemulsion Therapy Reduces Bacterial Wound Infection And Inflammation After Burn Injury”. Surgery. 2010

3 – “Nanoemulsion Therapy for Burn Wounds Is Effective as a Topical Antimicrobial Against Gram-Negative and Gram-Positive Bacteria”. Burn Care Res. 2016, March /April: 37(2); 104-114

Other scientific publications describing the extensive research conducted using topical NanoBio-based applications are listed below:

  • “Treatment With a Novel Topical Nanoemulsion (NB-001) Speeds Time to Healing of Recurrent Cold Sores”. Drugs Dermatol. 2012 Aug; 11(8):970-7
  • “In Vitro Antibacterial Activity of NB-003 against Propionibacterium acnes”. Antimicrobial Agents And Chemotherapy, Sept. 2011,Vol. 55, No. 9, p. 4211–4217
  • “NB-002, A Novel Nanoemulsion With Broad Antifungal Activity Against Dermatophytes, Other Filamentous Fungi, And Candida Albicans”. Antimicrobial Agents And Chemotherapy, Aug. 2009, Vol. 53, No. 8, p. 3273–3279
  • “In Vitro Activities of a Novel Nanoemulsion against Burkholderia and Other Multidrug-Resistant Cystic Fibrosis-Associated Bacterial Species”. Antimicrobial Agents And Chemotherapy, Jan. 2009, Vol. 53, No. 1, p. 249–255
  • “The Fungicidal Activity Of Novel Nanoemulsion (X8W60PC) Against Clinically Important Yeast And Filamentous Fungi”. Mycopathologia 155: 195–201, 2001
  • “A Novel Surfactant Nanoemulsion With A Unique Non-Irritant Topical Antimicrobial Activity Against Bacteria, Enveloped Viruses And Fungi”. Microbiol. Res. (200I) 156, I-7
  • “Inactivation Of Ebola Virus With A Surfactant Nanoemulsion”. Acta Tropica 87 (2003) 315/320
  • “Antimicrobial Mechanism Of Action Of Surfactant Lipid Preparations In Enteric Gram-Negative Bacilli”. Journal of Applied Microbiology 2000, 89, 397-403
  • “Prevention of Murine Influenza A Virus Pneumonitis by Surfactant Nano-emulsions”. Antiviral Chemistry & Chemotherapy, 2000, 11:41-49
  • “A Novel Surfactant Nanoemulsion with Broad-Spectrum Sporicidal Activity Against Bacillus Species”. The Journal of Infectious Diseases, 1999, 180:1939–49