Topical antiseptic system

a topical antiseptic and system technology, applied in the field of topical antiseptic systems, can solve the problems of increasing material and procedural costs as well as time for health care professionals, and general unsuitability for a variety of applications including the treatment of mucosal tissue or wounds

Inactive Publication Date: 2016-12-22
INFECTION CONTAINMENT CO LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0066]for a time and under conditions effective to form the antiseptic composition at use concentration.

Problems solved by technology

While alcohol-based antiseptics on the market for, inter alia, pre-surgical and pre-catherization antisepsis are fast acting they are generally unsuitable in a variety of applications including treatment of mucosal tissue or wounds.
In numerous instances of products with fast acting antimicrobial activity, the products lack a sustained activity to guard against microbial recontamination.
Any additional efficacy provided by the film must be balanced by their post-surgical removal requirement, which add to material and procedural costs as well as time by health care professionals.
These increased costs must be absorbed by the patient or health care provider.
In spite of recent advances in antiseptic compositions and their administration, there remains a need for compositions that result in rapid, effective, and / or sustained microbial kill.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example a

Preparation of Topical Antimicrobial Composition

[0277]Step 1

[0278]In an appropriate size of beaker, combine jojoba esters (40 parts), cetyl alcohol (2 parts) and a mixture of 65% glyceryl stearate / 35% PEG-100 stearate (80 parts). Heat the mixture to 72±3° C. until all ingredients are melted and a clear solution is obtained. Maintain the temperature at 72±3° C.

[0279]Step 2

[0280]In a manufacturing vessel, add purified water (qsad 1000 parts) and EDTA, disodium salt (2 parts). Heat the mixture to 72±3° C. with propeller mixing. Continue mixing until the EDTA disodium salt is completely dissolved. Maintain the temperature at 72±3° C.

[0281]Step 3

[0282]With mixing, add laureth −4 (40 parts), benzalkonium chloride (as a 50% aqueous solution) (2 parts) and PVP / Iodine (11 parts) to the manufacturing vessel. Continue mixing until the PVP-Iodine is dissolved and a homogeneous solution is obtained. Maintain the temperature at 72±3° C.

[0283]Step 4

[0284]Add the solution from Step 1 to the manufac...

example b

Procedure

[0289]Water (84.4 g) was placed in a sanitized mixing vessel. EDTA disodium salt (0.1 g) was added and dissolved into the water with continued mixing. Hydroxyelthylcellulose (HEC, 0.25 g) was slowly added with stirring to avoid clumping. NaOH (0.2 g of 20% by weight aqueous solution) was added and mixed until batch was completely smooth and free of “fish eyes”. The remaining ingredients (Floraesters K=20W jojoba (2.6 g), Laureth-4 (2 g), benzalkonium chloride (0.01 g), and sodium iodide (0.5 g) were independently added to ensure that each ingredient was dissolved before the addition of the next. PVP-iodine (9.726 g) was very slowly added to the mixture with mixing carried out as to avoid entrapment of air. PVP-I % was calculated according to “Available Iodine AS IS” assay found on COA (11.31%) for a total of 1.1% Iodine. The batch was mixed until batch was completely homogeneous.

APPEARANCE: Semi-viscous clear liquid

COLOR: Dark reddish / brown

ODOR: Characteristic-iodine

Initial...

example c

[0292]Water (74.5 g) was placed in a sanitized mixing vessel. EDTA disodium salt (0.1 g) was added and dissolved into the water with continued mixing. Pluracare F 127 (analogous material to Poloxamer 407, 10 g) was slowly added to avoid introduction of excess air. PVP-iodine (9.73 g) was very slowly added to the mixture with mixing carried out as to avoid entrapment of air. PVP-I % was calculated according to “Available Iodine AS IS” assay found on COA (11.31%) for a total of 1.1% Iodine. NaOH (0.6 g of 20% by weight aqueous solution) was added and mixed until batch was completely smooth and free of “fish eyes”. The remaining ingredients (Floraesters K=20W jojoba (2.6 g), Laureth-4 (2 g), benzalkonium chloride (0.01 g), and sodium iodide (0.5 g) were independently added to ensure that each ingredient was dissolved before the addition of the next. The batch was mixed until batch was completely homogeneous.

APPEARANCE: Semi-viscous clear liquid

COLOR: Dark reddish / brown

ODOR: Characteris...

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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.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Application Ser. No. 62 / 183,059, filed Jun. 22, 2015, 62 / 200,900, filed Aug. 4, 2015 and 62 / 327,736, filed Apr. 26, 2016, the disclosures of each of which are hereby incorporated herein by reference in their entireties.FIELD OF THE INVENTION[0002]The present invention relates to antiseptic compositions containing an antimicrobial agent. More particularly, this invention relates to antiseptic compositions comprising an antimicrobial agent and methods of their use, including transdermal or topical administration for treatment of various microbial infections, including tissue, particularly skin antisepsis and / or nasal mucosal tissue antisepsis.BACKGROUND OF THE INVENTION[0003]In order to reduce the risk of infection, doctors and / or hospital surgical teams typically prepare or disinfect the skin prior to any invasive procedure such as surgery, catheterization, or needle puncture. Two tra...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A01N25/24A61K31/79A61K31/14A61K47/38A61K47/34A61K47/44A61K47/10A01N59/12A01N33/12A01N37/44A61K9/00A61K31/198
CPCA01N25/24A61K9/0014A61K9/0043A61K31/79A61K31/14A61K47/38A61K47/34A61K47/44A61K47/10A01N59/12A01N33/12A01N37/44A61K31/198A61Q17/005A61K47/183A61K47/186A61K33/18A01N25/10A01N65/00A01N65/08A61K8/416A61K8/44A61K8/731A61K8/90A61K8/20A61K45/06A61K2300/00Y02A50/30
Inventor DYER, DENNIE W.GARRUTO, JOHN A.
Owner INFECTION CONTAINMENT CO LLC
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