Antiseptic compositions and methods

An antiseptic composition comprising:

• an antimicrobial agent selected from the group consisting of I2, an iodophor, and a combination thereof, wherein the antimicrobial agent is present in an amount sufficient to provide an available iodine concentration of at least about 0.25 wt-%;
• a hydroxycarboxylic acid buffer in an amount of at least about 5 wt-%;
• water;
• and
• a film-forming polymer comprising hydrophilic and hydrophobic moieties.

An antiseptic composition comprising:

• an iodophor in an amount of greater than 5 wt-%, 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;
• a hydroxycarboxylic acid buffer in an amount of at least about 5 wt-%;
• and
• water.

An antiseptic composition comprising:

• an antimicrobial agent selected from the group consisting of I2, an iodophor, and a combination thereof, wherein the antimicrobial agent is present in an amount sufficient to provide an available iodine concentration of at least about 0.25 wt-%;
• a hydroxycarboxylic acid buffer in an amount of at least about 5 wt-%;
• water;
• and
• a substantive film-forming polymer;
• wherein a dry film of the composition is stable and substantive.

An antiseptic composition comprising:

• an antimicrobial agent selected from the group consisting of I2, an iodophor, and a combination thereof, wherein the antimicrobial agent is present in an amount sufficient to provide an available iodine concentration of at least about 0.25 wt-%;
• a hydroxycarboxylic acid buffer in an amount of at least about 5 wt-%;
• water;
• and
• a substantive film-forming polymer;
• wherein a dry film of the composition is stable and substantive and demonstrates one or more of the following characteristics:
• reduces normal skin flora by at least about 1 log in 2 minutes on a dry human skin site using ASTM testing method E1173-93 and a 30-second scrub with gauze soaked in the composition using moderate pressure;
• is substantially nontacky when in the form of a dry film;
• demonstrates a Draize score of zero in no greater than about 96 hours according to the Rabbit Eye Irritation Test;
• or
• adheres to a PSA-coated tape at a level of at least about 50% of the level of adhesion of the PSA-coated tape applied over dried BETADINE surgical scrub and paint solutions when measured using a 180 degree peel test after applying the PSA-coated tape to a dry film on dry human skin by rolling with a 2.1-kg, 5.1-cm wide roller, waiting at least 1 minute, and removing the PSA-coated tape at a peel angle of 180 degrees at a speed of 30.5 cm/minute.

An antiseptic composition comprising:

• an antimicrobial agent selected from the group consisting of I2, an iodophor, and a combination thereof, wherein the antimicrobial agent is present in an amount sufficient to provide an available iodine concentration of at least about 0.25 wt-% to about 1.0 wt-%;
• a hydroxycarboxylic acid buffer in an amount of about 5 wt-% to about 15 wt-%;
• water;
• and
• a substantive film-forming polymer;
• wherein the hydroxycarboxylic acid buffer comprises a compound represented by the formula:
• R1(CR2OH)n(CH2)mCOOH
• wherein:
• R1 and R2 are each independently H or a (C1-C8) saturated straight, branched, or cyclic alkyl group, a (C6-C12)aryl group, or a (C6-C12)aralkyl or alkaryl group wherein the alkyl groups are saturated straight, branched, or cyclic, wherein R1 and R2 may be optionally substituted with one or more carboxylic acid groups;
• m=0 or 1;
• and
• n=1-3.

A method of disinfecting tissue comprising:

• applying directly to tissue an antiseptic composition comprising:
• an antimicrobial agent selected from the group consisting of 12, an iodophor, and a combination thereof, wherein the antimicrobial agent is present in an amount sufficient to provide an available iodine concentration of at least about 0.25 wt-%;
• a hydroxycarboxylic acid buffer in an amount of at least about 5 wt-%;
• and
• water;
• and
• allowing the antiseptic composition to remain on the tissue.

A method of disinfecting tissue comprising:

• applying directly to tissue an antiseptic composition comprising:
• an iodophor in an amount of greater than 5 wt-%, 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;
• a hydroxycarboxylic acid buffer in an amount of at least about 5 wt-%;
• and
• water;
• and
• allowing the antiseptic composition to remain on the tissue.

A method of disinfecting tissue comprising:

• applying directly to tissue an antiseptic composition comprising:
• an antimicrobial agent selected from the group consisting of I2, an iodophor, and a combination thereof, wherein the antimicrobial agent is present in an amount sufficient to provide an available iodine concentration of at least about 0.25 wt-%;
• a hydroxycarboxylic acid buffer in an amount of at least about 5 wt-%;
• water;
• and
• a substantive film-forming polymer;
• wherein a dry film of the composition is stable and substantive;
• and
• allowing the antiseptic composition to remain on the tissue.

A method of disinfecting tissue comprising:

• applying directly to tissue an antiseptic composition comprising:
• an antimicrobial agent selected from the group consisting of I2, an iodophor, and a combination thereof, wherein the antimicrobial agent is present in an amount sufficient to provide an available iodine concentration of at least about 0.25 wt-%;
• a hydroxycarboxylic acid buffer in an amount of at least about 5 wt-%;
• water;
• and
• a film-forming polymer comprising hydrophilic and hydrophobic moieties;
• and
• allowing the antiseptic composition to remain on the tissue.

A method of disinfecting tissue comprising:

• applying directly to tissue an antiseptic composition comprising:
• an antimicrobial agent selected from the group consisting of I2, an iodophor, and a combination thereof, wherein the antimicrobial agent is present in an amount sufficient to provide an available iodine concentration of at least about 0.25 wt-%;
• a hydroxycarboxylic acid buffer in an amount of at least about 5 wt-%;
• water;
• and
• a substantive film-forming polymer;
• wherein a dry film of the composition is stable and substantive and demonstrates one or more of the following characteristics:
• reduces normal skin flora by at least about 1 log in 2 minutes on a dry human skin site using ASTM testing method E1173-93 and a 30-second scrub with gauze soaked in the composition using moderate pressure;
• is substantially nontacky when in the form of a dry film;
• demonstrates a Draize score of zero in no greater than about 96 hours according to the Rabbit Eye Irritation Test;
• or
• adheres to a PSA-coated tape at a level of at least about 50% of the level of adhesion of the PSA-coated tape applied over dried BETADINE surgical scrub and paint solutions when measured using a 180 degree peel test after applying the PSA-coated tape to a dry film on dry human skin by rolling with a 2.1-kg, 5.1-cm wide roller, waiting at least 1 minute, and removing the PSA-coated tape at a peel angle of 180 degrees at a speed of 30.5 cm/minute;
• and
• allowing the antiseptic composition to remain on the tissue.

A method of disinfecting tissue comprising:

• applying directly to tissue an antiseptic composition comprising:
• an antimicrobial agent selected from the group consisting of I2, an iodophor, and a combination thereof, wherein the antimicrobial agent is present in an amount sufficient to provide an available iodine concentration of at least about 0.25 wt-% to about 1.0 wt-%;
• a hydroxycarboxylic acid buffer in an amount of about 5 wt-% to about 25 wt-%;
• water;
• and
• a substantive film-forming polymer;
• wherein the hydroxycarboxylic acid buffer comprises a compound represented by the formula:
• R1(CR2OH)n(CH2)mCOOH
• wherein:
• R1 and R2 are each independently H or a (C1-C8) saturated straight, branched, or cyclic alkyl group, a (C6-C12)aryl group, or a (C6-C12)aralkyl or alkaryl group wherein the alkyl groups are saturated straight, branched, or cyclic, wherein R1 may be optionally substituted with one or more carboxylic acid groups;
• m=0 or 1;
• and
• n=1-3;
• and
• allowing the antiseptic composition to remain on the tissue.

A method of making an antiseptic composition, the method comprising combining components comprising:

• an antimicrobial agent selected from the group consisting of I2, an iodophor, and a combination thereof, wherein the antimicrobial agent is present in an amount sufficient to provide an available iodine concentration of at least about 0.25 wt-%;
• a hydroxycarboxylic acid buffer in an amount of at least about 5 wt-%;
• water;
• and
• a substantive film-forming polymer.