	US 12,447,188 B2
	Compositions and methods for the antiseptic treatment of biofilms on mammalian tissue
Stephen Thomas Woody, Asheville, NC (US)
Assigned to Avadim Holdings, Inc., Asheville, NC (US)
Filed by Avadim Health IP, Inc., Asheville, NC (US)
Filed on Jun. 12, 2020, as Appl. No. 16/900,863.
Claims priority of provisional application 62/860,727, filed on Jun. 12, 2019.
Prior Publication US 2021/0244785 A1, Aug. 12, 2021
Int. Cl. A61K 36/886 (2006.01); A61K 9/00 (2006.01); A61K 31/4166 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01); A61K 47/18 (2017.01); A61K 47/22 (2006.01); A61K 47/24 (2006.01); A61K 47/26 (2006.01); A61K 47/34 (2017.01); A61P 31/02 (2006.01)

CPC A61K 36/886 (2013.01) [A61K 9/0053 (2013.01); A61K 31/4166 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/183 (2013.01); A61K 47/186 (2013.01); A61K 47/22 (2013.01); A61K 47/24 (2013.01); A61K 47/26 (2013.01); A61K 47/34 (2013.01); A61P 31/02 (2018.01)]

6 Claims

1. A composition for treating the surface of inflamed chronically infected mammalian tissue, consisting of:

at least one ingredient selected from each of the following categories: an amphoteric surfactant category (a) ingredient having a wt % from about 2.0 to about 8.0 wt. %, a skin compatible anti-inflammatory category (b) ingredient having a wt % from about 6.0 to about 12.0 wt. %, and a skin compatible anti-foaming category (c) ingredient having a wt % from about 0.19 to about 0.27 wt. %;

at least one ingredient selected from each of the following categories: a cell growth promoting category (d) ingredient having a wt % from about 4.0 to about 10.0 wt. %, an immune system enhancing category (e) ingredient having a weight percentage from about 2.0 to about 5.0 wt. %, a fast acting skin compatible antimicrobial category (f) ingredient having a weight percentage from about 2.0 to about 10.0 wt. %, an absorption facilitation category (g) ingredient having a weight percentage from about 0.5 to about 5.0 wt. %, a humectant and emollient category (h) ingredient having a weight percentage from about 2.0 to about 11.0 wt. %, a free radical scavenging category (i) ingredient having a weight percentage from about 4.0 to about 8.0 wt. %, and a healing promoting category (j) ingredient having a weight percentage from about 2.0 to about 4.0 wt. %;

a biocompatible preservative category (k) ingredient of potassium sorbate having a weight percentage from about 0.01 to about 0.10 wt. %; and a plant based extract category (l) ingredient of olibanum (frankensense) having a weight percentage from about 0.009 wt. % to about 5.0 wt. %; with the balance of the composition being approximately 70 to 90 wt. % water;

wherein the composition has an acidic pH of from 4.0 to 5.0, is gamma irradiated at 4 kGY to 35 kGY to a sterility assurance level of 10⁻²to 10⁻⁶, and provides the hybrid benefits of: (1) treating microbials, (2) treating biofilms, (3) maintaining, nourishing and moisturizing, (4) maintaining the natural pH; (5) maintaining and promoting immunocompetency, and (6) protecting and preserving barrier function of the tissue's stratum corneum.