Antiseptic containing adhesive composition.

0001/ This invention is directed to an antiseptic or germicide containing adhesive composition that is useful for various medical purposes. The adhesive composition comprises a pressure sensitive rubbery elastomer having intimately dispersed therein one or more water soluble or water swellable hydrocolloids and one or more antiseptic or germicidal agents.

0002This invention is directed to the discovery that by incorporating one or more antiseptic or germicidal agents within an adhesive composition the potential for bacterial overgrowth is considerably diminished and in many cases entirely eliminated while at the same time not interfering with the healing qualities of the bandage.

0003The adhesive composition comprises a pressure sensitive rubbery elastomer material having intimately dispersed therein one or more water soluble or water swellable hydrocolloids and one or more antiseptic or germicidal agents. This adhesive composition can have a continuous or discontinuous polymeric film such as polyethylene, polypropylene, polyvinylchloride, polyurethane, etc., laminated to one surface as described in United States Patents 3,339,546 and 4,192,785 or it can be included in a multi-layered bandage having an intermediate polymeric foam layer such as polyurethane foam as described in 3,972,328.

0004Suitable rubbery elastomers for inclusion within the adhesive composition are natural or synthetic viscous gum-like substances such as natural rubber, silicone rubber, acrylonitrile rubber, polyurethane rubber, polyisobutylenes, etc., with polyisobutylenes being preferred (these are commercially available as Vistanex and Hyvis). The viscous gum-like substance acts as a binder for the hydrocolloid particles and, in-addition, renders the final adhesive mass tacky, elastic, and pliable. The elastomeric materials should comprise from about 30% to about 60% by weight of the adhesive composition, about

0005preferably from about 35% to about 50% by weight of the adhesive composition.

0006Suitable water soluble or water swellable hydrocolloids for inclusion within the adhesive composition are gelatin, pectin, sodium carboxymethylcellulose, guar gum, alginic acid, locust bean gum, karaya, etc., and various mixtures thereof. Preferably the hydrocolloid component is a mixture of pectin, gelatin, and sodium carboxymethylcellulose. The hydrocolloid or mixture of hydrocolloids should comprise from about 30% to about 65% by weight of the adhesive layer, preferably from about 40% to about 60% by weight of the adhesive layer.

0007Suitable antiseptic and germicidal agents for inclusion within the adhesive composition are iodophors such as povidone iodine, iodine crystals, potassium iodide, etc., and mixtures thereof which are included so as to provide from about 1% to about 5% by weight of free iodine in the adhesive composition; phenolics such as phenol, cresol, chlorthymol, thymol, p-chlorophenol, hexachlorophene, etc., and mixtures thereof which are included at from about 0.5% to about 5% by weight of the adhesive composition; mercurials such as phenylmercuric chloride, phenylmercuric nitrate, phenylmercuric borate, thimerosal, mercury bichloride, nitromersol, etc., and mixtures thereof which are included at from about 0.00001.to about 0.001% by weight of the adhesive composition; nitrofurazone which is included at from about 0.1% to about 5% by weight of the adhesive composition; and chlorhexidine which is included at from about 0.5% to about 5% by weight of the adhesive composition. The iodophors are the preferred antiseptic agents for inclusion within the adhesive composition.

0008Various optional ingredients can also be included within the adhesive composition. For example, a cohesive strengthening agent can be included as described in United States Patent 4,192,785, as well as small amounts of a plasticizer such as mineral oil, an antioxidant such as butylated hydroxyanisole, a deodorant or perfume agent.

0009The adhesive composition is prepared by mixing the hydrocolloids and antiseptic materials in a suitable blender. The viscous substance is then added and mixing is continued until a homogeneous dough-like mass is produced. This mass is extruded or rolled into slab of desired thickness. A thin film of polymeric material can be laminated to one surface and the other side can be covered with silicone coated release paper. The slab can then be cut into wafers of desired size.

0010Bandages including the antiseptic or germicide containing adhesive composition of this invention are useful in treating various wounds. In particular, such bandages will be beneficial in the treatment of dermal ulcers and in burn therapy.,

0011Bandages including the antiseptic or germicide containing adhesive composition of this invention can be sterilized by conventional techniques such as gamma irradiation.

0012The following examples are illustrative of the invention.

Example 1

0013An antiseptic containing adhesive composition is prepared containing the following ingredients: <tables id="tabl0001" num="0001"><img file="EP0055023A2_D0001.tif" /></tables>

0014The gelatin, pectin, sodium, carboxymethylcellulose, and povidone iodine are mixed in a blender until thoroughly dispersed. The polyisobutylene is added and mixing is continued until a dough-like mass is produced. This mass is rolled or extruded into sheets of approximately 1/16 inch thickness. A thin film (about 1 mil.) of polyethylene is laminated to one side and the other is covered with silicone coated release.

Example 2

0015An antiseptic containing adhesive composition is prepared containing the following ingredients: <tables id="tabl0002" num="0002"><img file="EP0055023A2_D0002.tif" /></tables>

0016The iodine crystals, potassium iodide, and sodium carboxymethylcellulose are mixed in a blender until thoroughly dispersed. The pectin and gelatin powders are added with continuous stirring. Finally, the polyisobutylene is added with continuous stirring until a dough-like mass is produced. The mass is rolled or extruded into sheets of approximately 1/16 inch thickness. A thin film of polyethylene or other polymeric material is laminated to one side and the other is covered with silicone coated release paper.

Examples 3 - 11

0017Following the procedure of Examples 1 and 2, additional antiseptic adhesive compositions can be prepared containing the following ingredients. <tables id="tabl0003" num="0003"><img file="EP0055023A2_D0003.tif" /></tables><tables id="tabl0004" num="0004"><img file="EP0055023A2_D0004.tif" /></tables>

Example 12

0018In this in vitro experiment the antiseptic properties of the bandage prepared according to Example 1 is compared with a control bandage prepared by'replacing the povidone iodine in Example 1 with an additional 100 gms. of sodium carboxymethylcellulose.

0019A microbiological medium is prepared containing: <tables id="tabl0005" num="0005"><img file="EP0055023A2_D0005.tif" /></tables>

0020This aqueous mixture is sterilized by autoclave at 121°C for 15 minutes and has a pH after sterilization of 7.3.

002150 ml. portions of the microbiological medium are placed in Petri dishes (150 x 20 mm) and inoculated separately with the microbs listed below. The medium is inoculated in the ratio of 1.0 ml. of organisms suspension containing at least 10⁸ colony forming units per ml. for each liter of medium. <tables id="tabl0006" num="0006"><img file="EP0055023A2_D0006.tif" /></tables>

0022Four filter paper discs are placed on the ,agar surface of each inoculated plate 25 mm. in from the edge at 90 intervals to each other. 18 mm. circles are cut from both the control and iodinated bandage, two of each for any single-seeded Petri dish. The release paper is removed from the samples and two control sample circles and two iodinated sample circles are placed (adhesive side down) on the filter paper discs already on each inoculated Petri dish. A metal weight is placed 'On top of each sample circle and the Petri dishes are kept at 5°C to prediffuse overnight. After overnight incubation the following results in zones of inhibition are (average of two) obtained. <tables id="tabl0007" num="0007"><img file="EP0055023A2_D0007.tif" /></tables>