US2016366879A1PendingUtilityA1

Topical antiseptic system

55
Assignee: INFECTION CONTAINMENT COMPANY LLCPriority: Jun 22, 2015Filed: Jun 22, 2016Published: Dec 22, 2016
Est. expiryJun 22, 2035(~8.9 yrs left)· nominal 20-yr term from priority
Inventors:Dennie W. DyerJohn A. Garruto
A61K 9/0043A61K 47/10A61K 47/34A61K 47/38A61K 8/416A61K 31/14A01N 33/12A61K 31/79A61K 8/44A01N 59/12A61K 47/44A61K 47/186A61K 8/90A01N 37/44A61K 31/198A61K 8/731A61K 9/0014A01N 25/10A61K 45/06A61K 8/20A61K 33/18A01N 65/08A61K 47/183A01N 25/24A01N 65/00A61Q 17/005Y02A50/30
55
PatentIndex Score
0
Cited by
0
References
0
Claims

Abstract

Novel antimicrobial compositions and kits thereof containing these antimicrobial compositions, methods of manufacture and methods of use thereof are disclosed. The novel aqueous transdermal or topical delivery systems are useful, inter alia, for treatment of various microbial infections, including for use on tissue infections, particularly skin antisepsis and/or nasal mucosal tissue antisepsis to a mammalian host in need thereof.

Claims

exact text as granted — not AI-modified
What is claimed: 
     
         1 . A topical antimicrobial composition comprising:
 a first antimicrobial agent selected from the group consisting of I 2 , an iodophor, and a combination thereof, wherein the antimicrobial agent is present in an amount sufficient to provide an available iodine concentration of from about 0.25 wt-% or more to about 1.5 wt-% or less;   a second antimicrobial agent;   a thickening agent comprising a nonionic cellulose derivative or nonionic copolymer, or combination thereof; and   water;
 wherein:
 said composition is substantially free of any hydroxycarboxylic acid buffer; and 
 said composition is substantially free of any fragrance. 
 
   
     
     
         2 . A topical antimicrobial composition according to  claim 1 , wherein the thickening agent comprises a nonionic cellulose derivative. 
     
     
         3 . A topical antimicrobial composition according to  claim 1 , wherein the thickening agent comprises a nonionic copolymer. 
     
     
         4 . A topical antimicrobial composition according to  claim 2 , wherein the nonionic cellulose derivative comprises hydroxyethyl cellulose. 
     
     
         5 . An antimicrobial composition according to  claim 3 , wherein the nonionic copolymer comprises hydrophilic and hydrophobic regions. 
     
     
         6 . A topical antimicrobial composition according to  claim 5 , wherein the nonionic copolymer comprises a poloxamer. 
     
     
         7 . An antimicrobial composition according to  claim 1 , wherein the first antimicrobial agent comprises an iodophor in an amount of greater than 5 wt-% and sufficient to provide an available iodine concentration of about 1.5 wt-% or less, wherein the iodophor comprises a carrier selected from the group consisting of a polyvinylpyrrolidone, a copolymer of N-vinyl lactam, a polyether glycol, a polyvinyl alcohol, a polyacrylamide, a polysaccharide, and combinations thereof. 
     
     
         8 . An antimicrobial composition according to  claim 1 , wherein the composition is substantive to mucosal or skin tissue. 
     
     
         9 . An antimicrobial composition according to  claim 1 , wherein the composition has a Brookfield viscosity of about 500 cP or less. 
     
     
         10 . An antimicrobial composition according to  claim 1 , wherein the composition has a Brookfield viscosity of about 400 cP or less. 
     
     
         11 . An antimicrobial composition according to  claim 1 , wherein the composition has a Brookfield viscosity of about 300 cP or less. 
     
     
         12 . An antimicrobial composition according to  claim 1 , wherein the iodophor carrier comprises povidone. 
     
     
         13 . An antimicrobial composition according to  claim 1 , wherein the iodophor comprises povidone-iodine. 
     
     
         14 . An antimicrobial composition according to  claim 13 , wherein the iodophor comprises povidone-iodine USP. 
     
     
         15 . An antimicrobial composition according to  claim 13 , wherein the iodophor further comprises an iodide salt. 
     
     
         16 . An antimicrobial composition according to  claim 13  further comprising a surfactant. 
     
     
         17 . An antimicrobial composition according to  claim 16 , wherein the surfactant comprises a nonionic or anionic surfactant, or combination thereof. 
     
     
         18 . An antimicrobial composition according to  claim 17 , wherein the surfactant comprises a nonionic surfactant. 
     
     
         19 . An antimicrobial composition according to  claim 18 , wherein the surfactant further comprises an anionic surfactant. 
     
     
         20 . An antimicrobial composition according to  claim 1 , wherein the second antimicrobial agent comprises a neutral or cationic antimicrobial agent. 
     
     
         21 . An antimicrobial composition according to  claim 20 , wherein the second antimicrobial agent comprises a compound selected from the group consisting of: diazolidinyl urea, methylchloroisothiazolinone, methylisothiazolinone, disodium EDTA, and a benzalkonium salt, or a combination thereof. 
     
     
         22 . An antimicrobial composition according to  claim 20 , wherein the second antimicrobial agent comprises disodium EDTA. 
     
     
         23 . An antimicrobial composition according to  claim 1 , wherein the second antimicrobial agent comprises a benzalkonium compound. 
     
     
         24 . An antimicrobial composition according to  claim 23 , wherein the benzalkonium compound comprises benzalkonium chloride. 
     
     
         25 . An antimicrobial composition according to  claim 1 , further comprising a nonionic surfactant. 
     
     
         26 . An antimicrobial composition according to  claim 1 , further comprising a nonionic surfactant and an anionic surfactant. 
     
     
         27 . An antimicrobial composition according to  claim 1 , further comprising an emollient. 
     
     
         28 . An antimicrobial composition according to  claim 27 , wherein the emollient comprises a fatty alcohol. 
     
     
         29 . An antimicrobial composition according to  claim 26 , further comprising an emollient. 
     
     
         30 . An antimicrobial composition according to  claim 29 , wherein the emollient comprises a fatty alcohol. 
     
     
         31 . An antimicrobial composition according to  claim 30 , wherein the anionic surfactant comprises a salt of a fatty acid. 
     
     
         32 . An antimicrobial composition according to  claim 6 , wherein the poloxamer has the formula I: 
       
         
           
           
               
               
           
         
         wherein, on average, each a is independently from about 80 to about 120 and b is from about 50 to about 80. 
       
     
     
         33 . An antimicrobial composition according to  claim 32  each a is independently from about 90 to about 110 and b is from about 55 to about 70. 
     
     
         34 . An antimicrobial composition according to  claim 6 , wherein the poloxamer has an approximate molecular mass of the poly(oxypropylene) core of 3500 to about 4500 g/mol and about 65 to about 75% of poly(oxyethylene) content by weight of the poloxamer. 
     
     
         35 . An antimicrobial composition according to  claim 27 , wherein the emollient comprises at least one jojoba ester or derivative thereof. 
     
     
         36 . An antimicrobial composition according to  claim 21 , wherein the second antimicrobial agent comprises a compound selected from the group consisting of: disodium EDTA and a benzalkonium salt, or a combination thereof. 
     
     
         37 . An antimicrobial composition according to  claim 36 , wherein:
 the second antimicrobial agent comprises benzalkonium chloride and disodium EDTA;   the surfactant comprises laureth-4; and   the emollient comprises a saponified ester of jojoba oil.   
     
     
         38 . A method of disinfecting tissue comprising:
 applying directly to tissue an antiseptic composition at use concentration, wherein the use concentration of the composition comprises:
 an iodophor comprising a carrier selected from the group consisting of a polyvinylpyrrolidone, a copolymer of N-vinyl lactam, a polyether glycol, a polyvinyl alcohol, a polyacrylamide, a polysaccharide, and combinations thereof; wherein the iodophor is present in an amount sufficient to provide an available iodine concentration of at least 0.25 wt-%; 
 a second antimicrobial agent; 
 a thickening agent comprising a nonionic cellulose derivative or nonionic copolymer, or combination thereof; and 
 water;
 wherein:
 said composition is substantially free of any hydroxycarboxylic acid buffer; and 
 said composition is substantially free of any fragrance; and 
 
 
   allowing the antiseptic composition to remain on the tissue; wherein the composition has a pH of 1.5 to 6.5.   
     
     
         39 . A method according to  claim 38 , wherein the thickening agent comprises a nonionic cellulose derivative. 
     
     
         40 . A method according to  claim 38 , wherein the thickening agent comprises a nonionic copolymer. 
     
     
         41 . A method according to  claim 39 , wherein the nonionic cellulose derivative comprises hydroxyethyl cellulose. 
     
     
         42 . A method according to  claim 40 , wherein the nonionic copolymer comprises hydrophilic and hydrophobic regions. 
     
     
         43 . A method according to  claim 42 , wherein the nonionic copolymer comprises a poloxamer. 
     
     
         44 . A method of making an antiseptic composition at use concentration, the method comprising combining components comprising:
 an iodophor comprising a carrier selected from the group consisting of a polyvinylpyrrolidone, a copolymer of N-vinyl lactam, a polyether glycol, a polyvinyl alcohol, a polyacrylamide, a polysaccharide, and combinations thereof; wherein the iodophor is present in an amount sufficient to provide an available iodine concentration of at least 0.25 wt-%;   a second antimicrobial agent;   a thickening agent comprising a nonionic cellulose derivative or nonionic copolymer, or combination thereof; and   water;
 wherein:
 said composition is substantially free of any hydroxycarboxylic acid buffer; and 
 said composition is substantially free of any fragrance; 
 
   for a time and under conditions effective to form the antiseptic composition at use concentration.   
     
     
         45 . A method of disinfecting skin of a subject comprising:
 prior to an invasive procedure, applying directly to the skin of the subject an antiseptic composition at use concentration, wherein the use concentration of the composition comprises:
 a first antimicrobial agent selected from the group consisting of I 2 , an iodophor, and a combination thereof, wherein the antimicrobial agent is present in an amount sufficient to provide an available iodine concentration of from about 0.25 wt-% or more to about 1.5 wt-% or less; 
 a second antimicrobial agent; 
 a thickening agent comprising a nonionic cellulose derivative or nonionic copolymer, or combination thereof; and 
 water;
 wherein:
 said composition is substantially free of any hydroxycarboxylic acid buffer; and 
 said composition is substantially free of any fragrance; and 
 
 
   allowing the antiseptic composition to remain on the skin during the invasive procedure.   
     
     
         46 . A method of  claim 45 , wherein the invasive procedure is a surgical, catheterization, or needle puncture procedure. 
     
     
         47 . A method of  claim 45  wherein the antiseptic composition further includes a non-ionic surfactant or an emollient. 
     
     
         48 . A method of disinfecting mucosal tissue of a subject comprising:
 applying directly to the mucosal tissue of the subject an antiseptic composition at use concentration, wherein the use concentration of the composition comprises:
 a first antimicrobial agent selected from the group consisting of I 2 , an iodophor, and a combination thereof, wherein the antimicrobial agent is present in an amount sufficient to provide an available iodine concentration of from about 0.25 wt-% or more to about 1.5 wt-% or less; 
 a second antimicrobial agent; 
 a thickening agent comprising a nonionic cellulose derivative or nonionic copolymer or combination thereof; and 
 water;
 wherein:
 said composition is substantially free of any hydroxycarboxylic acid buffer; and 
 said composition is substantially free of any fragrance; and 
 
 
   allowing the antiseptic composition to remain on the mucosal tissue.   
     
     
         49 . A method of  claim 48 , wherein the mucosal tissue is nasal tissue. 
     
     
         50 . A method of  claim 48 , wherein the antiseptic composition further includes a non-ionic surfactant or an emollient. 
     
     
         51 . A method of decolonizing the nasal passages of a subject, the method comprising: applying the composition of  claim 1  to the nasal passages of the subject. 
     
     
         52 . A method of disinfecting the tissue of a subject, the method comprising: applying the composition of  claim 1  to the tissue of the subject. 
     
     
         53 . A topical antimicrobial composition comprising:
 a first antimicrobial agent selected from the group consisting of I 2 , an iodophor, and a combination thereof, wherein the antimicrobial agent is present in an amount sufficient to provide an available iodine concentration of from about 0.25 wt-% or more to about 1.5 wt-% or less;   a second antimicrobial agent comprising EDTA or a benzalkonium salt or combination thereof;   a thickening agent comprising a nonionic cellulose derivative or nonionic copolymer, or combination thereof;   an emollient comprising a saponified ester of a fatty acid and fatty alcohol;   a nonionic surfactant comprising laureth-4;   an iodide salt;   and   water;
 wherein:
 said composition is substantially free of any hydroxycarboxylic acid buffer; and 
 said composition is substantially free of any fragrance. 
 
   
     
     
         54 . A topical antimicrobial composition according to  claim 53  comprising:
 a first antimicrobial agent selected from the group consisting of I 2 , an iodophor, and a combination thereof, wherein the antimicrobial agent is present in an amount sufficient to provide an available iodine concentration of from about 0.25 wt-% or more to about 1.5 wt-% or less; 
 a second antimicrobial agent comprising EDTA and a benzalkonium salt; 
 a thickening agent comprising a nonionic copolymer; 
 an emollient comprising a saponified ester of a fatty acid and fatty alcohol; 
 a nonionic surfactant comprising laureth-4; 
 an iodide salt; and 
 water;
 wherein:
 said composition is substantially free of any hydroxycarboxylic acid buffer; and 
 
 
 
       said composition is substantially free of any fragrance. 
     
     
         55 . A topical antimicrobial composition according to  claim 53  comprising:
 a first antimicrobial agent selected from the group consisting of I 2 , an iodophor, and a combination thereof, wherein the antimicrobial agent is present in an amount sufficient to provide an available iodine concentration of from about 0.25 wt-% or more to about 1.5 wt-% or less; 
 a second antimicrobial agent comprising EDTA and a benzalkonium salt or combination thereof; 
 a thickening agent comprising a nonionic cellulose derivative; 
 an emollient comprising a saponified ester of a fatty acid and fatty alcohol; 
 a nonionic surfactant comprising laureth-4; 
 an iodide salt; 
 and 
 water;
 wherein:
 said composition is substantially free of any hydroxycarboxylic acid buffer; and 
 said composition is substantially free of any fragrance. 
 
 
 
     
     
         56 . A topical antimicrobial composition according to  claim 54  wherein the nonionic copolymer is a poloxamer.

Join the waitlist — get patent alerts

Track US2016366879A1 — get alerts on status changes and closely related new filings.

We store only your email — no account needed. See our privacy policy.