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WO1997015286A1 - Procede de traitement de blessures avec une composition en gel - Google Patents

Procede de traitement de blessures avec une composition en gel Download PDF

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Publication number
WO1997015286A1
WO1997015286A1 PCT/US1996/016974 US9616974W WO9715286A1 WO 1997015286 A1 WO1997015286 A1 WO 1997015286A1 US 9616974 W US9616974 W US 9616974W WO 9715286 A1 WO9715286 A1 WO 9715286A1
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WO
WIPO (PCT)
Prior art keywords
wound
composition
accordance
healing
gel
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US1996/016974
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English (en)
Inventor
Anthony N. Silvetti, Sr.
Anthony N. Silvetti, Jr.
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
LANGE MEDICAL PRODUCTS Inc
Original Assignee
LANGE MEDICAL PRODUCTS Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to IL12357196A priority Critical patent/IL123571A/xx
Application filed by LANGE MEDICAL PRODUCTS Inc filed Critical LANGE MEDICAL PRODUCTS Inc
Priority to AU75193/96A priority patent/AU7519396A/en
Publication of WO1997015286A1 publication Critical patent/WO1997015286A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0061—Use of materials characterised by their function or physical properties
    • A61L26/0066—Medicaments; Biocides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7015—Drug-containing film-forming compositions, e.g. spray-on
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
    • A61L26/0023—Polysaccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/21—Acids
    • A61L2300/214—Amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/23—Carbohydrates
    • A61L2300/232—Monosaccharides, disaccharides, polysaccharides, lipopolysaccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/428—Vitamins, e.g. tocopherol, riboflavin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/602—Type of release, e.g. controlled, sustained, slow

Definitions

  • the present invention relates to methods and compositions for beneficiating wound healing. More specifically, it relates to the use of glycerin, to form a gel, to beneficiate wound healing processes.
  • the injured area is extremely unstable physiologically. Following such injury or trauma, the normal physiological processes of the area in question may be severely compromised. Disruption in the normal pattern of skin growth, blood flow, and immunity may all be impaired to some extent by the trauma to the region. The health care provider treating such damaged tissue must therefore be able to control and eventually reverse these undesirable effects, while at the same time stimulating the processes that are necessary to achieve healing of the area.
  • silver sulfadiazine the current antibacterial agent of choice, is effective against gram-positive and gram- egative bacteria but many resistant strains have developed in the course of its use, particularly in the genus, Pseudomonas.
  • the commonly used 10% pvp iodine although effective against both gram-positive and gram-negative bacteria, can be quite painful to the patient upon application, kills white cells in the wound, specifically polymorphonuclear cells, lymphocytes, monocytes, macrophages, fibroblasts, endothelial cells and keratinocytes and may cause sensitization of an area already severely traumatized.
  • Other known antibacterial agents may be hampered in their use by low diffusibility of the composition, or a range of activity that covers relatively few types of microbes. Expense, as with substances such as the various silver salts, is also a factor to be considered.
  • the increased blood flow should also be accompanied by the formation of healthy granulation tissue.
  • the latter is a layer of highly vascularized tissue, containing numerous fibroblasts and collagen and ground substance, which supports the normal wound healing processes of recollagenation and re-epithelialization.
  • Another very critical aspect of the wound healing process is the initiation of wound closure.
  • This is generally a two-stage process, comprising contraction and epidermal migration.
  • Contraction is the process of bulk skin movement from the edges of the wound, while migration is the separation and movement of activated epidermal cells over the surface of the wound.
  • contraction itself may lead to some scarring, it is preferable to be able to speed healing in a manner which will increase the process of epidermal migration.
  • the process of migration is characterized by a stimulation of mitosis in the epidermal cells, accompanied by movement across the wound site.
  • the extent to which epidermal migration, and thus wound closure, can be promoted will also in some cases determine whether or not additional skin grafting is required to complete the healing of the wound.
  • the present invention relates to a composition
  • a composition comprising a therapeutically effective amount of a pharmaceutically acceptable film forming agent, an amount of sterile water to form an emulsion of desired viscosity, and a pharmaceutically acceptable gelatinization agent.
  • the present invention relates to a composition
  • a composition comprising an effective amount of a starch hydrolysate and glycerin, and preferably to a composition comprising glycerin and a starch hydrolysate having a dextrose equivalent of between 13 and 17.
  • the viscosity of the composition is preferably in the range of 31,000 to 35,000 centipoise in order to facilitate exposure of dermatological agents added to improve healing and to facilitate contact to all areas of the wound including those that may be partially covered.
  • the present invention also provides a method of treating wounds which comprises contacting the wound with the compositions described above for a period of time sufficient to initiate wound healing.
  • This invention relates to the treatment of skin wounds such as second and third degree burns, stasis ulcers, ischemic ulcers, trophic lesions, decubitus ulcers, severe cuts, deep punctures, abrasions, full thickness skin losses, skin undermining and deep skin tunnels.
  • skin wounds such as second and third degree burns, stasis ulcers, ischemic ulcers, trophic lesions, decubitus ulcers, severe cuts, deep punctures, abrasions, full thickness skin losses, skin undermining and deep skin tunnels.
  • the aforementioned skin wounds are characterized by open wounds or gaps in the skin tissue. As the healing process progresses these open wounds are gradually filled in by new cells which appear across the surface of the open wound so that when the healing process is complete, new skin tissue covers the former open area of the wound. Such cells are termed granulation tissue cells and the healing mechanism is a granulation cell formation process. These granulation cells and the blood capillaries supplying them are, however, very
  • the conventional technique to prevent this loss of vital body fluids has been to attempt to seal off the exuding wound. This has been accomplished, for example, by applying to the wound a layer of petrolatum or other water immiscible hydrocarbon material.
  • the tissue under such a layer of petrolatum is often excessively soft, wet and macerated. This softened tissue causes difficulty in both autograft and homograft skin transplants. It also provides an environment that is conducive to the development of secondary infections. The wound, therefore, must be cleansed constantly. But cleansing necessitates removal and replacement of the dressing and, as described above, there is great danger of rupturing the very fragile granulation tissue cells and capillaries during this removal and replacement process.
  • Soft protein, polysaccharide and polymer films have been used instead of a petrolatum seal in the treatment of burns or exudative lesions, but encounter the same problem of the underlying tissues becoming excessively soft.
  • these films collect exudate underneath and have a tendency to lift up and must then be removed and reapplied. This removal and replacement process again creates the possibility of rupturing the very fragile granulation cells and capillaries.
  • Powders containing starch have been used with many improvements over the protein films and petrolatum. However, with such powders an excessive amount of product must be applied to the wound to compensate for material falling outside the wound. Additionally, the powder, even with careful application, only contacts the areas of the wound where it lands.
  • the powder does not reach areas of the wound, particularly along the edge, that may be covered with torn skin nor does the powder reach areas of the wound that have more depth than the surrounding wound surface.
  • dermatological agents that aid healing can be blended with a starch-based powder, they are not necessarily available to the entire wound surface because the powder lacks fluidity.
  • a method for the treatment of the aforementioned skin wounds should, therefore, permit the use of a dressing which is as close as functionally possible to a natural wound scab, be permeable to exudate but not to proteinaceous material, be water vapor permeable, be flexible and not lift up, and inhibit the start or spread of secondary infections by reducing the bacteria count in and around the treated wound.
  • the dressing employed should be similar to a skin autograft in that it affords a natural protective covering which promotes healing, and yet it should, like a homograft, be easily sloughed off by the body when the healing process is completed.
  • starch hydrolysate has been shown to be an exceptionally effective treatment for burns, ulcers, lesions, and other skin defects such as wound dehiscences.
  • the starch hydrolysate mixes with the proteins in the wound fluid and forms a film which ultimately adheres to underlying tissue and which is semipermeable to air and fluid. It thus provides a covering which reduces plasma and fluid loss, while also preventing invasion and proliferation of pathogenic microbes.
  • Another outstanding property of the starch hydrolysate is its antimicrobial effects, such as bacteriostatic and bacteriocidal -Si- effects. The effects observed with use of starch hydrolysate are far superior to results seen with use of traditional wound- treating methods and the like.
  • the gel composition has all the benefits of a powder and provides for more efficient and more thorough wound healing.
  • the gel having a viscosity in the desired range, provides a better result in application of the starch hydrolysate to the wound. There is better product control with a gel and the fluid flow of the gel brings the wound healing benefits of the starch hydrolysate to areas of the wound a powder may not reach.
  • starch hydrolysate is a generic term of a mixture of carbohydrates most commonly classified according to their dextrose equivalent.
  • the starch hydrolysate of the present invention is one which has a dextrose equivalent of no more than 60, and preferably no more than 30.
  • the dextrose equivalent of the starch hydrolysate of the present invention is between about 7 and 20.
  • the dextrose equivalent of the starch hydrolysate is between about 7.5 and 30. Most preferably, the starch hydrolysate of the present invention has a dextrose equivalent in the range of between about 13 and 17. Those skilled in the art are aware that starch hydrolysates having a dextrose equivalent in this latter most preferred range are more specifically called maltodextrins. It will also be understood that "pharmaceutically acceptable” means purified and sterilized. While any of the known methods, including dry heat, filtration, or irradiation may be used for the sterilization, the preferred method of the present invention is Gamma Radiation.
  • Starch is a polymer of anhydro-D-glucose units. Hydrolysis of starch produces a mixture of polymers of various molecular weights ranging from 200 glucose units or more down to maltose (2 glucose units) and D-glucose itself. Because of their nature the accepted way to describe the polymers formed by hydrolysis of starch is by their D.E. value, which is an expression of the average extent of hydrolysis. Low D.E. products suitable for use in the present invention may be made by subjecting gelatinized starch to the hydrolytic action of an acid or an enzyme or by successive treatments with such agents.
  • the hydrolysate so formed is then purified by conventional means such as by subjecting it to filtration, centrifugation, decantation or the like to separate and remove any water insoluble materials remaining after hydrolysis.
  • the hydrolysate, dissolved in water to the extent of 10 grams per 100 ml, will contain less than 0.1 percent insoluble material as determined by filtration and drying the residue to constant weight under vacuum at 100°C.
  • the hydrolysate material may be subjected to further purification steps known to the art such as carbon or clay treatment, dialysis, electrodialysis, osmosis, ion exclusion, ion exchange and the like.
  • a starch such as waxy starch
  • a single enzyme application of bacterial alpha-amylase More speci ically, an aqueous slurry of a starch such as waxy starch having a solids content less than 50 percent is subjected to the hydrolytic action of bacterial alpha-amylase under suitable conditions to produce the starch hydrolysate material.
  • This material is further specifically characterized as having the sum of the percentages (dry basis) of saccharides therein with a degree of polymerization of 1 to 6, divided by the D.E. to provide a ratio greater than about 2.0. This ratio is referred to as the "characteristic" or “descriptive" ratio. Those materials having a descriptive ratio less than about 2 are somewhat undesirable in that they exhibit less water solubility and also tend to form a haze in solution as compared to those products with a ratio of about 2 or greater.
  • Suitable starch hydrolysate materials may also be made via a number of other routes.
  • a mixture of starch and water having a solids content less than 50 percent may be first subjected to the hydrolytic action of a bacterial alpha-amylase. After an initial thinning by the enzyme, the resulting partial hydrolysate is heated to a temperature sufficient to solubilize any unsolubilized starch. Since this temperature also tends to inactivate the enzyme, it is then necessary to subject the solubilized partial hydrolysate to a second hydrolysis by treatment with more bacterial alpha-amylase to obtain the final starch hydrolysate.
  • a third method of making the preferred class of starch hydrolysate materials consists of hydrolyzing a mixture of starch and water by the action of acid to reach a D.E. of less than about 35.
  • the partial hydrolysate is subsequently subjected to the action of bacterial alpha-amylase to obtain a starch hydrolysate having a D.E. between 5 and 25.
  • a particularly preferred product useful here has the following specifications: moisture content, 5% (five) maximum; 9-13 D.E.; pH of 4.5 to 5.5 when in aqueous solution at 10% (ten) solids; an average bulk density of 28-35 pounds per cubic foot and a descriptive ratio of about 2.
  • starch hydrolysate material used in the invention Any starch or starch like material may be used to prepare the starch hydrolysate material used in the invention. Suitable materials include cereal and tuber starches, such as corn, wheat, potato, tapioca, rice, sago and grain sorghum; waxy starches may also be used. Hydrolysis may be carried out by enzymes, acids or combinations of the two.
  • the starch hydrolysate used in the present invention is a pharmaceutically acceptable maltodextrin, such as the commercially available product sold under the brand name Maltrin M150. The weight percentage of maltodextrin in the wound healing composition should be in the range of 57 to 77% to form the continuous phase with the sterile water.
  • the weight percentage of maltodextrin would be between 65 and 69% of the composition.
  • the present invention relates to a composition in the form of a gel.
  • a gel is defined as an emulsion in which the dispersed phase has combined with the continuous phase to produce a semi-solid material as a jelly.
  • the gel characteristics of the present composition allow for a better result in application of the starch hydrolysate to the wound.
  • the wound healing gel is formed by blending the starch hydrolysate with a sufficient amount of sterile water to form the continuous phase. A gelatinization agent is then mixed into the continuous phase so that it becomes the dispersed phase.
  • the result is an emulsion in semi-solid form with the gelatinization agent acting as the dispersed phase and the starch hydrolysate and water acting as the continuous phase.
  • the gel has a final viscosity in the range of 29,000 to 37,000 centipoise.
  • the gelatinization agent can be any compound capable of acting as the dispersed phase in a semi-solid emulsion.
  • the present invention relates to a composition comprising the gelatinization agent, glycerin.
  • the glycerin should be USP/FCC grade, for example, as the type that may be supplied by American International Chemical, Inc.
  • the weight percentage, sufficient to act as the dispersed phase of the semi-solid emulsion, of glycerin in the wound healing composition should be in the range of 2 to 20%.
  • the weight percentage of glycerin is in the range of 9 to 11%.
  • a sufficient amount of sterile water is used to form a continuous phase consisting of the starch hydrolysate and the sterile water.
  • the weight percentage of sterile water in the wound healing composition should be in the range of 11 to 31% to form the continuous phase. Preferably, the weight percentage of water would be between 21 and 23% of the composition.
  • the blending of maltodextrin, the preferred starch hydrolysate compound, with sterile water, to form a continuous phase, and then introduction of the preferred gelatinization agent, glycerin, to form an emulsion produces a gel having several advantages over dry powders as a wound-healing treatment. The primary benefits are more efficient delivery of dermatological agents having a wound-healing effect and more thorough application of those agents to the wound area.
  • the selected gel viscosity has fluid flow so that the composition moves and spreads into areas of the wound that are not exposed to the external application of other wound-healing compositions such as a powder.
  • the gel can better penetrate areas along the edge of the wound where there may be layers of skin partially covering the wound.
  • the fluid flow of the gel also more efficiently delivers wound-healing agents to all areas of the wound because a gel spreads and a powder is limited in its activity to the areas of the wound where it lands and adheres.
  • the gel improves wound-healing by improving delivery of the agents that cause wound closure by enhancing mitotic division of the epidermal cells.
  • Another benefit of the gel composition of the selected viscosity is better product control in application and a reduced amount of product used.
  • These benefits are provided by a gel emulsion having a viscosity in the range of 29,000 to 37,000 cp.
  • the gel viscosity was selected to provide the above-described benefits. Not all semi-solid emulsions would provide these benefits.
  • a higher viscosity gel would not adequately disperse the wound-healing agents and a lower viscosity gel would cause slip and a lack of adherence to the wound surface.
  • the gel can be applied so that it only contacts the wound area and is not wasted on the surrounding skin surface as would happen during application of other compositions such as a powder. For example, powder that does not immediately adhere to the wound surface falls away from the wound area. With a gel, the entire quantity of gel applied to the wound remains in contact with the wound surface.
  • the present invention of a gel composition with improved wound healing capability has the following composition: M-150 maltodextrin (66 to 68.25 weight %) , Sterile Water (21 to 23 weight %) , and Glycerin (9 to 11 weight %) , with a final viscosity in the range of 31,000 to 35,000 centipoise.
  • M-150 maltodextrin 66 to 68.25 weight %)
  • Sterile Water 21 to 23 weight
  • Glycerin 9 to 11 weight %)
  • there is a cumulative effect in the prevention of bacterial and viral growth provided by the combination of maltodextrin and glycerin.
  • Maltodextrin by itself, is highly bacteriostatic. High concentrations of glycerin are known to be virucidal and possibly bacteriostatic.
  • a gel composition containing both maltodextrin and glycerin has the cumulative capability of preventing the growth of both bacteria and viruses.
  • a principal additional component of the composition of the present invention is one which includes ascorbic acid or a pharmaceutically acceptable salt thereof.
  • ascorbic acid or a pharmaceutically acceptable salt thereof promotes the formation and growth of healthy granulation tissue.
  • pharmaceutically acceptable ascorbate salts contemplated for use in this invention are sodium ascorbate, potassium ascorbate and calcium ascorbate.
  • the acid, ascorbic acid itself is most preferred.
  • the ascorbate component is preferably used in an amount of from about 0.1-5% of the total weight of the composition, and most preferably comprises about 1-3.5% of the composition.
  • another component of the composition of the present invention is a monosaccharide such as fructose.
  • a monosaccharide such as fructose.
  • the benefits of using a monosaccharide in conjunction with a film-forming agent were disclosed in U.S. Pat. No. 4,889,844, the teaching of which is incorporated by reference.
  • a mixture of a starch hydrolysate with fructose has several beneficial effects including hastening the process of revascularization of the wound, a greater level of activity in the development of granulation tissue, and acceleration of wound closure such that the need for a skin graft is reduced or eliminated.
  • Fructose also has a synergistic effect with starch hydrolysate in the inhibition of microbial growth at the wound site.
  • the weight percentage of fructose in the wound healing composition should be in the range of 0.25 to 3% of the composition. Preferably, the weight percentage of fructose would be between 1 and 2% of the composition.
  • the materials used in practicing the invention should, of course, be sterile. Sterilization may be accomplished by any of the known sterilization procedures.
  • purified starch hydrolysate material having a D.E. of less than about 35 is used as the film-forming agent, however, the preferred sterile, purified starch hydrolysate material has a D.E. of between about 5 and about 25.
  • the starch hydrolysate is water soluble so that it easily forms a continuous phase with sterile water and so that the continuous phase is miscible with the dispersed phase consisting of the gelatinization agent. Additionally, the water soluble gel composition need not be mechanically removed from a wound; it can be washed away by flooding with water. When undermining or tunneling occurs in an exudative skin wound, this composition dissolves in the exudate.
  • dressing with the gel composition forms a covering which is very similar to a natural wound scab.
  • This covering has been found to be flexible so that some movement of the treated area is possible without causing the covering to lift up and away from the exudative wound.
  • the gel composition of the invention also has been found to act as a semi-permeable membrane which allows edemic liquids to pass through it while proteinaceous materials are retained within the body.
  • the exudate is clean and relatively free of proteinaceous materials. It, therefore, does not support bacteriological proliferation to the same extent as exudate containing proteinaceous fluids. At the same time excessive build up of edemic liquids is also minimized. The possibility of the patient going into shock is, therefore, greatly reduced.
  • the gel when applied to a skin wound, the gel reduces the bacterial count of an infected wound, and inhibits infection of an uninfected wound.
  • the sterile, purified gel composition may be admixed with any of the antibacterial agents known to the art to be effective in the prevention or treatment of secondary infections, e.g., iodine, penicillin, nitrofuranes and the sulfa drugs such as silver sulfadiazine.
  • proteolytic enzymes known by the art to be effective in promoting healing may also be admixed with the gel composition.
  • nutritive agents and vitamins such as ascorbic acid (Vitamin C) , may also be admixed or applied along with the gel composition to promote the formation and growth of healthy granulation tissue.
  • composition of the present invention is one or more amino acids which also improve healing.
  • amino acids which also improve healing.
  • one or more, up to all, of the following amino acids may be provided in the composition of the present invention: isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophane, valine, tyrosine, alanine, arginine, glycine, proline, histidine, serine, asparagine, aspartic acid, cysteine, cystine, glutamine and glutamic acid.
  • glycine, proline and lysine are particularly preferred.
  • amino acid refers to both the pure form and the hydrochloric acid salts of the amino acids.
  • amino acid refers to both the pure form and the hydrochloric acid salts of the amino acids.
  • amino acid refers to both the pure form and the hydrochloric acid salts of the amino acids.
  • one, two or all three of the above preferred amino acids are included in the composition of this invention.
  • the amount of amino acid in the composition should not exceed 1%.
  • the gel composition when applied as a dressing to an exudative wound, a film resembling a natural wound scab is formed. To promote the formation of this protective film, the treated wound should not be tightly bandaged, but should only be loosely covered so that the wound can "breathe.” It has been found that application of the gel composition serves also to reduce the pain that is usually associated with burns, ulcers, and the like.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Materials Engineering (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Cette invention concerne un procédé de traitement de blessures qui consiste à mettre la blessure en contact, pendant un laps de temps suffisant, avec une quantité thérapeutiquement efficace d'une composition en gel comportant une phase continue d'un hydrolysat d'amidon et d'eau stérilisée et, une phase dispersée d'un agent de gélatinisation, ladite composition ayant une viscosité comprise entre 29000 et 37000 cp. Il est possible d'utiliser comme hydrolysat d'amidon de la maltodextrine et comme agent de gélatinisation de la glycérine. Ladite composition peut également contenir de l'acide ascorbique ainsi que des agents antibactériens et des agents nutritifs qui favorisent la formation et la croissance de tissu de granulation.
PCT/US1996/016974 1995-10-26 1996-10-23 Procede de traitement de blessures avec une composition en gel Ceased WO1997015286A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
IL12357196A IL123571A (en) 1995-11-01 1996-10-18 Process for aqueous granulation of a macrolide antibiotic, pharmaceutical granules prepared according to the process and a method for increasing the hardness of such pharmaceutical granules
AU75193/96A AU7519396A (en) 1995-10-26 1996-10-23 Method of treating wounds with a gel composition

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US54879395A 1995-10-26 1995-10-26
US08/548,793 1995-10-26

Publications (1)

Publication Number Publication Date
WO1997015286A1 true WO1997015286A1 (fr) 1997-05-01

Family

ID=24190422

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1996/016974 Ceased WO1997015286A1 (fr) 1995-10-26 1996-10-23 Procede de traitement de blessures avec une composition en gel

Country Status (2)

Country Link
AU (1) AU7519396A (fr)
WO (1) WO1997015286A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000045802A3 (fr) * 1999-02-08 2001-03-01 Idexx Lab Inc PROCEDES PERMETTANT DE FAVORISER LA CICATRISATION DES PLAIES ET ULCERS CUTANES PAR UTILISATION DE COMPOSITIONS A BASE DE α-D-GLUCANS
EP1206271A4 (fr) * 1999-07-22 2003-03-26 Deroyal Ind Inc Composition et procede ameliorant la cicatrisation des plaies

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4889844A (en) * 1985-10-22 1989-12-26 Silvetti Sr Anthony N Fructose containing wound healing preparation

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4889844A (en) * 1985-10-22 1989-12-26 Silvetti Sr Anthony N Fructose containing wound healing preparation

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000045802A3 (fr) * 1999-02-08 2001-03-01 Idexx Lab Inc PROCEDES PERMETTANT DE FAVORISER LA CICATRISATION DES PLAIES ET ULCERS CUTANES PAR UTILISATION DE COMPOSITIONS A BASE DE α-D-GLUCANS
EP1206271A4 (fr) * 1999-07-22 2003-03-26 Deroyal Ind Inc Composition et procede ameliorant la cicatrisation des plaies

Also Published As

Publication number Publication date
AU7519396A (en) 1997-05-15

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