US 11,707,433 B2
Methods and compositions for treating diabetic foot ulcers
Jeffrey Clark, Madison, MS (US); and Jeffery King, Madison, MS (US)
Assigned to PATHWAY DEVELOPMENT LLC, Madison, MS (US)
Filed by Pathway Development, LLC, Madison, MS (US)
Filed on Sep. 1, 2020, as Appl. No. 17/9,509.
Claims priority of provisional application 62/894,826, filed on Sep. 1, 2019.
Prior Publication US 2021/0059934 A1, Mar. 4, 2021
Int. Cl. A61K 9/08 (2006.01); A61K 31/7036 (2006.01); A61K 31/4725 (2006.01); A61K 38/14 (2006.01); A61K 31/497 (2006.01); A61K 31/4174 (2006.01); A61M 3/02 (2006.01)
CPC A61K 9/08 (2013.01) [A61K 31/4174 (2013.01); A61K 31/4725 (2013.01); A61K 31/497 (2013.01); A61K 31/7036 (2013.01); A61K 38/14 (2013.01); A61M 3/0204 (2014.02); A61M 3/0229 (2013.01)] 15 Claims
 
1. A method for the treatment of diabetic foot ulcers using water-soluble anti-infective medication, comprising administering to a subject an effective amount of an irrigation therapy solution consisting of about 1 gram to about 10 grams of a pharmaceutical composition dissolved in a volume of about 1.5 to about 5 liters of water,
wherein the pharmaceutical composition comprises:
a first antimicrobial agent, a second antimicrobial agent, a third antimicrobial agent, and a powder excipient base;
wherein the first antimicrobial agent is an aminoglycoside antibiotic or a fluoroquinolone, and is present in an amount of from about 15 wt % to about 35 wt %;
wherein the second antimicrobial agent is glycopeptide antibiotic, and is present in an amount of from about 15 wt % to about 40 wt %;
wherein the third antimicrobial agent is an azole antifungal or an imidazole antifungal, and is present in an amount of from about 1 wt % to about 15 wt %;
wherein the powder excipient base is present in an amount of from about 10 wt % to about 50 wt %;
wherein the wt % is based on the total weight of the first antimicrobial agent, the second antimicrobial agent, the third antimicrobial agent, and the powder excipient base such that the total wt % for foregoing components is 100 wt %; and
wherein the first antimicrobial agent, the second antimicrobial agent, the third antimicrobial agent, and the powder excipient base are a homogeneously dispersed powder mixture prior to being dissolved;
wherein the subject is diagnosed with diabetes;
wherein the irrigation therapy solution is contained in a suitable irrigation therapy delivery device;
wherein administering comprises the subject placing at least one foot in the irrigation therapy delivery device for a suitable period of time.